A Phase 3 interventional study of Relugolix and Estradiol/norethindrone acetate in Uterine Leiomyoma and Uterine Fibroids, sponsored by Myovant Sciences GmbH. Completed at 104 sites in 8 countries. Open to female participants aged 18 Years to 51 Years. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by Myovant Sciences GmbH (part of Sumitomo Pharma Co., Ltd.) · Phase 3, Interventional, and Treatment
Among 10 studies testing relugolix in Leiomyoma — 2 open to participants now, 2 under way, 2 of them phase 3. relugolix · Leiomyoma.
Among the 10 studies testing relugolix in Leiomyoma, this one is the 7th largest by enrollment, is the only one that started in 2018, is one of 9 in phase 3, and was the 7th registered.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
Browse Leiomyoma studies →2 of the 10 studies testing relugolix in Leiomyoma are open now, in 2 countries. Recruiting first, the newest first:
Qilu Pharmaceutical Co., Ltd. · Sites in China
Sumitomo Pharma Switzerland GmbH · Sites in United States
By country, each count listing its studies:
relugolix: first FDA approval 2020 (ORGOVYX), first EMA approval 2021. What it is approved for, and how studies give it, is on its page →
Of the 43 Leiomyoma studies recruiting now, 21 (49%) set no upper age limit and 21 (49%) stop at 75 or younger; 3 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 51 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2018.
This study's enrollment of 229 is above the median of 66 across 306 interventional studies indexed under Leiomyoma.
Median enrollment 332 across the 10 interventional studies. Of the 8 that completed or were terminated, 7 (88%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 10 have an industry lead sponsor. The 4 most frequent:
Myovant Sciences GmbH is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 6 (60%) have results posted.
Myovant Sciences GmbH has 5 studies filed under Leiomyoma — fewer than ten, so there is no comparison to draw.
1 of the studies testing relugolix in Leiomyoma that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06671548Phase 3Qilu Pharmaceutical Co., Ltd.Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids | 2026-11-12 |
Among the 10 studies testing relugolix in Leiomyoma, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment, including a 24-week treatment period in a parent study (study MVT-601-3001 or MVT-601-3002) and a 28-week treatment period in the open-label extension study (MVT-601-3003), and who meet the definition of responder, defined as a patient who demonstrates a menstrual blood loss of \< 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.
This randomized withdrawal study is an international phase 3 double-blind, placebo-controlled study that will enroll eligible patients with uterine fibroids who have completed the 24-week treatment period in a parent study (MVT-601-3001 or MVT-601-3002) and the 28-week treatment period of the open-label extension study (MVT-601-3003). When including treatment during the parent study and the extension study, patients completing this randomized withdrawal study will have received up to a total of 104 weeks of treatment with relugolix.
Approximately 360 women with heavy menstrual bleeding associated with uterine fibroids completing the extension study with a response to treatment will be eligible to participate in this study. A responder is defined as a patient who demonstrates a menstrual blood loss of \< 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.
Screening procedures will be done on the same day as the Week 52 visit for the extension study. This visit will be referred to as the "Week 52/Baseline visit." When the Week 52/Baseline procedures in the extension study have been completed, the investigator will assess patient eligibility for participation in this study. The eligibility assessment will be based on data available at the Week 52/Baseline visit.
Patients will be asked to provide feminine products for alkaline hematin analysis at each visit until the analysis confirms the return of heavy menstrual bleeding. The patients will then be offered retreatment with open-label relugolix with E2/NETA with the onset of the next menses. They will resume collection of feminine products for alkaline hematin analysis until two consecutive analyses confirm resolution of heavy menstrual bleeding (menstrual blood loss of \< 80 mL). Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, and assessments of bone mineral density.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 52 weeks.
Drug: Relugolix · Drug: Estradiol/norethindrone acetate
* Placebo for relugolix co-administered with placebo for E2/NETA for up to 52 weeks or until heavy menstrual bleeding returns. * Retreatment with open-label relugolix with E2/NETA will be offered if heavy menstrual bleeding returns.
Drug: Placebo for relugolix · Drug: Placebo for E2/NETA
Relugolix 40 mg tablet administered orally once daily
Also known as: TAK-385
Drug pages: Estradiol · Norethindrone Acetate
Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
Also known as: E2/NETA, Low-dose hormonal add-back
Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor
Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor
Percentage Of Participants Who Maintained MBL Volume Of <80 Milliliters (mL) At Week 76 During The Randomized Treatment Period
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume \< 80 mL through Week 76 using the Kaplan-Meier method.
Time frame: Week 52/Baseline up to Week 76
Time To MBL Volume ≥80 mL During The Randomized Treatment Period
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Time frame: From Week 52/Baseline through Week 104
Percentage Of Participants Who Maintained MBL Volume Of <80 mL At Week 104 During The Randomized Treatment Period
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume \< 80 mL through Week 104 using the Kaplan-Meier method.
Time frame: Week 52/Baseline up to Week 104
Percentage Of Participants Achieving Or Maintaining Amenorrhea At Week 76 During The Randomized Treatment Period
Assessed using participant daily diary and MBL volume measured using the alkaline hematin method. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea, or No feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (\<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was \>70%.
Time frame: Week 76
Change From Week 52/Baseline To Week 76 In MBL Volume During The Randomized Treatment Period
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Time frame: Week 52/Baseline to Week 76
Change From Week 52/Baseline To Week 104 In MBL Volume During The Randomized Treatment Period
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Time frame: Week 52/Baseline to Week 104
Percentage Change From Week 52/Baseline To Week 76 In MBL Volume During The Randomized Treatment Period
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Time frame: Week 52/Baseline to Week 76
Percentage Change From Week 52/Baseline To Week 104 In MBL Volume During The Randomized Treatment Period
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Time frame: Week 52/Baseline to Week 104
Percentage Of Participants Achieving Or Maintaining Amenorrhea At Week 104 During The Randomized Treatment Period
Assessed using participant daily diary and MBL volume measured using the alkaline hematin method. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea or no feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (\<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was \>70%.
Time frame: Week 104
Percentage Of Participants Who Responded (MBL Volume <80 mL) To Retreatment During The Retreatment Period
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Time frame: From Initiation of Retreatment to Week 104
Percentage Of Participants Whose Menses Had Resumed During The Randomized Treatment Period
Participants who were previously amenorrhoeic were deemed to resume menses according to the following rules: MBL volume of collected feminine product was ≥5 mL; MBL volume of collected feminine product was \<5 mL; however, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit; no feminine products were returned because the participant failed to collect used products per protocol; however, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit; or no feminine products were returned due to other reasons that indicated menstruation had occurred; also, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit.
Time frame: Week 52/Baseline to Week 76 and Week 104
Time To Resumption Of Menses For Participants Who Were Amenorrhoeic At Week 52/Baseline During The Randomized Treatment Period
Assessed using participant daily diary. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea, or No feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (\<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was \>70%.
Time frame: Week 52/Baseline up to Week 104
Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Time frame: Week 52/Baseline to Week 76
Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Time frame: Week 52/Baseline to Week 104
Percentage Of Participants With MBL Volume Of ≥80 mL At Week 76 And Week 104 During the Randomized Treatment Period
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Time frame: From Week 52/Baseline to Week 76 and Week 104
Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Time frame: Week 52/Baseline to Week 64
Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Time frame: Week 52/Baseline to Week 76
Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Time frame: Week 52/Baseline to Week 104
Percentage Of Participants Who Had Hemoglobin Level ≤10.5 g/dL Over Time During The Randomized Treatment Period
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Time frame: Week 52/Baseline to Week 76
Percentage Of Participants Who Had Hemoglobin Level ≤10.5 g/dL Over Time During The Randomized Treatment Period
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Time frame: Week 52/Baseline to Week 104
Percentage Of Participants Who Had Hemoglobin Level <11.6 g/dL Over Time During The Randomized Treatment Period
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Time frame: Week 52/Baseline to Week 76
Percentage Of Participants Who Had Hemoglobin Level <11.6 g/dL Over Time During The Randomized Treatment Period
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Time frame: Week 52/Baseline to Week 104
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Time frame: Week 52/Baseline to Week 76
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Time frame: Week 52/Baseline to Week 104
Change From Week 52/Baseline In SF-36v2 Summary Component Scores During The Randomized Treatment Period
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary (PCS) score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary (MCS) score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Time frame: Week 52/Baseline to Week 76
Change From Week 52/Baseline In SF-36v2 Summary Component Scores During The Randomized Treatment Period
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary (PCS) score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary (MCS) score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Time frame: Week 52/Baseline to Week 104
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
The PGA for function is a 1-item questionnaire designed to assess participant's impression of the impact on their function related to uterine fibroids affected their usual activities and was completed on paper. The PGA for function was evaluated using a 5-point Likert scale (1 = No limitation at all; 5 = Extreme limitation) with higher numbers representing worse results. Endpoint values represent the worsening of function (deterioration), improvement of function (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (No limitation at all) to 5 (Extreme limitation) and a 4-category improvement represents a change from 5 (Extreme limitation) to 1 (No limitation at all).
Time frame: Week 52/Baseline to Week 76
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
The PGA for function is a 1-item questionnaire designed to assess participant's impression of the impact on their function related to uterine fibroids affected their usual activities and was completed on paper. The PGA for function was evaluated using a 5-point Likert scale (1 = No limitation at all; 5 = Extreme limitation) with higher numbers representing worse results. Endpoint values represent the worsening of function (deterioration), improvement of function (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (No limitation at all) to 5 (Extreme limitation) and a 4-category improvement represents a change from 5 (Extreme limitation) to 1 (No limitation at all).
Time frame: Week 52/Baseline to Week 104
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids and was completed on paper. The PGA for symptoms was evaluated using a 5-point Likert scale (1 = Not severe; 5 = Extremely severe) with higher numbers representing worse results. Endpoint values represent the worsening of symptoms (deterioration), improvement of symptoms (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (Not severe) to 5 (Extremely severe) and a 4-category improvement represents a change from 5 (Extremely severe) to 1 (Not severe).
Time frame: Week 52/Baseline to Week 76
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids and was completed on paper. The PGA for symptoms was evaluated using a 5-point Likert scale (1 = Not severe; 5 = Extremely severe) with higher numbers representing worse results. Endpoint values represent the worsening of symptoms (deterioration), improvement of symptoms (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (Not severe) to 5 (Extremely severe) and a 4-category improvement represents a change from 5 (Extremely severe) to 1 (Not severe).
Time frame: Week 52/Baseline to Week 104
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Work Time Missed Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent work time missed due to uterine fibroids was calculated from hours missed due to uterine fibroids divided by the sum of hours missed due to uterine fibroids plus hours actually worked. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Time frame: Week 52/Baseline up to Week 76
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Work Time Missed Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent work time missed due to uterine fibroids was calculated from hours missed due to uterine fibroids divided by the sum of hours missed due to uterine fibroids plus hours actually worked. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Time frame: Week 52/Baseline up to Week 104
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Impairment While Working Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent impairment while working due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Time frame: Week 52/Baseline up to Week 76
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Impairment While Working Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent impairment while working due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Time frame: Week 52/Baseline up to Week 104
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Overall Work Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent overall work impairment due to uterine fibroid symptoms was calculated from the work time missed due to uterine fibroids plus the value calculated from 1 minus the work time missed value multiplied by the value for impairment while working due to uterine fibroids. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Time frame: Week 52/Baseline up to Week 76
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Overall Work Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent overall work impairment due to uterine fibroid symptoms was calculated from the work time missed due to uterine fibroids plus the value calculated from 1 minus the work time missed value multiplied by the value for impairment while working due to uterine fibroids. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Time frame: Week 52/Baseline up to Week 104
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Activity Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent activity impairment due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented activity) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Time frame: Week 52/Baseline up to Week 76
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Activity Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent activity impairment due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages (0 to 100%), with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Time frame: Week 52/Baseline up to Week 104
Change From Week 52/Baseline In The UFS-QoL Bleeding And Pelvic Discomfort Score During The Randomized Treatment Period
Assessed using the UFS-QOL which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer the following questions: heavy bleeding during your menstrual period (Question 1), passing blood clots during your menstrual period (Question 2), and feeling tightness or pressure in your pelvic area (Question 5). Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1, 2, and 5 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater distress and a lower score of less distress (high scores = bad).
Time frame: Week 52/Baseline to Week 76
Change From Week 52/Baseline In The UFS-QoL Bleeding And Pelvic Discomfort Score During The Randomized Treatment Period
Assessed using the UFS-QOL which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer the following questions: heavy bleeding during your menstrual period (Question 1), passing blood clots during your menstrual period (Question 2), and feeling tightness or pressure in your pelvic area (Question 5). Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1, 2, and 5 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater distress and a lower score of less distress (high scores = bad).
Time frame: Week 52/Baseline to Week 104
Original: Change From Week 52/Baseline In The UFS-QoL Symptom Severity Score During The Randomized Treatment Period
Assessed using the UFS-QOL, which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1 through 8 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater symptom severity and a lower score of lower symptom severity (negative score = improvement).
Time frame: Week 52/Baseline to Week 76
New: Change From Week 52/Baseline In The UFS-QoL Symptom Severity Score During The Randomized Treatment Period
Assessed using the UFS-QOL, which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1 through 8 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater symptom severity and a lower score of lower symptom severity (negative score = improvement).
Time frame: Week 52/Baseline to Week 104
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Assessed using the UFS-QOL which, is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. Items are scored on a 5-point scale, ranging from "none of the time" to "all of the time." The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Questions 9 through 37 were used to calculate the total scores and the following subscales: concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function. All raw scores are transformed to normalized scores with a range of possible values from 0 to 100. A positive score indicates improvement.
Time frame: Week 52/Baseline to Week 76
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Assessed using the UFS-QOL which, is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. Items are scored on a 5-point scale, ranging from "none of the time" to "all of the time." The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Questions 9 through 37 were used to calculate the total scores and the following subscales: concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function. All raw scores are transformed to normalized scores with a range of possible values from 0 to 100. A positive score indicates improvement.
Time frame: Week 52/Baseline to Week 104
Predose Concentration Of Estradiol At Week 56
Blood samples were collected from participants for estradiol measurements and were analyzed using a standard clinical methodology. The change from Week 52/Baseline in estradiol concentration at Week 56 was presented in this outcome.
Time frame: Week 52/Baseline and Week 56
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
Assessed by percentage of participants with AEs and serious AEs (SAEs). An AE was defined as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or a congenital anomaly/birth defect. Events of heavy menstrual bleeding were only reported if the event met criteria as an SAE. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time frame: Week 52/Baseline up to Week 104
Percent Change From Week 52/Baseline In BMD At Lumbar Spine (L1-L4)
Assessed by dual-energy X-ray absorptiometry scan at the lumbar spine (L1-L4), total hip \[presented separately\], and femoral neck (same leg within each participant) \[presented separately\] at each designated timepoints. The least squares means and their 95% CI were based on analysis of covariance model with treatment, stratification factors, race as fixed factors, and age at Week 52/Baseline, Week 52/Baseline BMD value, and body mass index at Week 52/Baseline as covariates.
Time frame: Week 52/Baseline to Week 104
Percent Change From Week 52/Baseline In BMD At Femoral Neck And Total Hip
Assessed by dual-energy X-ray absorptiometry scan at the lumbar spine (L1-L4) \[presented separately\], total hip, and femoral neck (same leg within each participant) at each designated timepoints. The least squares means and their 95% CI were based on analysis of covariance model with treatment, stratification factors, race as fixed factors, and age at Week 52/Baseline, Week 52/Baseline BMD value, and body mass index at Week 52/Baseline as covariates.
Time frame: Week 52/Baseline to Week 104
Participants who completed the long-term extension study with a response to treatment, signed the informed consent form, and met all eligibility criteria were enrolled in the study.
| Milestone | Relugolix Plus Estradiol (E2) /Norethindrone Acetate (NETA) (Group A) | Placebo (Group B) |
|---|---|---|
| Started | 115 | 114 |
| Received at least 1 dose of study drug | 115 | 113 |
| Completed | 89 | 86 |
| Not completed | 26 | 28 |
| Withdrew: Adverse event | 4 | 3 |
| Withdrew: Protocol deviation | 0 | 1 |
| Withdrew: Lost to follow-up | 6 | 4 |
| Withdrew: Withdrawal by subject | 6 | 8 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Pregnancy | 0 | 1 |
| Withdrew: Other | 9 | 9 |
| Withdrew: Participants who did not receive any study drug | 0 | 1 |
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume \< 80 mL through Week 76 using the Kaplan-Meier method.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percentage Of Participants Who Maintained MBL Volume Of <80 Milliliters (mL) At Week 76 During The Randomized Treatment Period | 78.43 (69.33 to 85.12) | 15.08 (8.91 to 22.76) |
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
| weeks | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Time To MBL Volume ≥80 mL During The Randomized Treatment Period | NA (NA to NA) | 5.9 (5.4 to 6.3) |
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume \< 80 mL through Week 104 using the Kaplan-Meier method.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percentage Of Participants Who Maintained MBL Volume Of <80 mL At Week 104 During The Randomized Treatment Period | 69.79 (59.72 to 77.80) | 11.75 (6.32 to 19.00) |
Assessed using participant daily diary and MBL volume measured using the alkaline hematin method. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea, or No feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (\<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was \>70%.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percentage Of Participants Achieving Or Maintaining Amenorrhea At Week 76 During The Randomized Treatment Period | 57.39 (47.83 to 66.56) | 13.27 (7.62 to 20.95) |
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
| mL | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline To Week 76 In MBL Volume During The Randomized Treatment Period | 6.6 ± 42.80 | 11.5 ± 27.45 |
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
| mL | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline To Week 104 In MBL Volume During The Randomized Treatment Period | 2.1 ± 28.85 | 3.9 ± 10.92 |
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
| percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percentage Change From Week 52/Baseline To Week 76 In MBL Volume During The Randomized Treatment Period | 652.0 ± 1759.37 | 55.0 ± 219.15 |
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
| percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percentage Change From Week 52/Baseline To Week 104 In MBL Volume During The Randomized Treatment Period | -42.0 ± 48.80 | — |
Assessed using participant daily diary and MBL volume measured using the alkaline hematin method. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea or no feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (\<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was \>70%.
| percentage of patients | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percentage Of Participants Achieving Or Maintaining Amenorrhea At Week 104 During The Randomized Treatment Period | 58.26 (48.70 to 67.39) | 10.62 (5.61 to 17.82) |
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percentage Of Participants Who Responded (MBL Volume <80 mL) To Retreatment During The Retreatment Period | 96.15 (80.36 to 99.90) | 97.75 (92.12 to 99.73) |
Participants who were previously amenorrhoeic were deemed to resume menses according to the following rules: MBL volume of collected feminine product was ≥5 mL; MBL volume of collected feminine product was \<5 mL; however, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit; no feminine products were returned because the participant failed to collect used products per protocol; however, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit; or no feminine products were returned due to other reasons that indicated menstruation had occurred; also, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Week 76 | 35.29 (26.14 to 46.48) | 91.54 (84.33 to 96.28) |
| Week 104 | 41.12 (31.22 to 52.75) | 92.75 (85.86 to 97.04) |
Assessed using participant daily diary. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea, or No feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (\<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was \>70%.
| weeks | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Time To Resumption Of Menses For Participants Who Were Amenorrhoeic At Week 52/Baseline During The Randomized Treatment Period | NA (42.6 to NA) | 5.4 (5.0 to 5.9) |
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
| g/dL | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period | 0.3 ± 0.96 | -0.1 ± 1.10 |
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
| g/dL | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period | 0.3 ± 1.03 | -0.2 ± 1.36 |
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| At Week 76 | 21.57 (14.88 to 30.67) | 84.92 (77.24 to 91.09) |
| At Week 104 | 30.21 (22.20 to 40.28) | 88.25 (81.00 to 93.68) |
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
| percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period | 1.3 ± 6.75 | -4.3 ± 8.53 |
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
| percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period | 2.8 ± 8.30 | -0.8 ± 9.10 |
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
| percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period | 2.3 ± 8.94 | -0.7 ± 10.65 |
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percentage Of Participants Who Had Hemoglobin Level ≤10.5 g/dL Over Time During The Randomized Treatment Period | 4.94 (1.36 to 12.16) | 10.00 (1.23 to 31.70) |
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percentage Of Participants Who Had Hemoglobin Level ≤10.5 g/dL Over Time During The Randomized Treatment Period | 5.08 (1.06 to 14.15) | 0 (0 to 36.94) |
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percentage Of Participants Who Had Hemoglobin Level <11.6 g/dL Over Time During The Randomized Treatment Period | 6.17 (2.03 to 13.82) | 15.00 (3.21 to 37.89) |
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percentage Of Participants Who Had Hemoglobin Level <11.6 g/dL Over Time During The Randomized Treatment Period | 6.78 (1.88 to 16.46) | 25.00 (3.19 to 65.09) |
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Physical Functioning | 1.1 ± 4.24 | -2.3 ± 5.16 |
| Role-Physical | 0.3 ± 4.80 | -1.2 ± 4.75 |
| Bodily Pain | 0.6 ± 8.02 | -0.3 ± 9.78 |
| General Health | 0 ± 6.68 | -3.1 ± 6.81 |
| Vitality | 0.5 ± 7.87 | 0.4 ± 8.83 |
| Social Functioning | -0.2 ± 7.85 | -2.9 ± 6.65 |
| Role-Emotional | 0.6 ± 7.38 | -1.0 ± 7.23 |
| Mental Health | 0.5 ± 8.30 | -1.0 ± 9.98 |
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Physical Functioning | 0.5 ± 5.44 | 0.5 ± 2.23 |
| Role-Physical | -0.5 ± 6.49 | -0.6 ± 2.88 |
| Bodily Pain | 1.9 ± 7.36 | 1.7 ± 8.42 |
| General Health | -0.6 ± 5.67 | -5.5 ± 7.72 |
| Vitality | 0.5 ± 7.53 | 3.0 ± 8.84 |
| Social Functioning | -0.4 ± 7.85 | -0.6 ± 3.21 |
| Role-Emotional | -0.2 ± 7.32 | -3.9 ± 6.29 |
| Mental Health | -0.8 ± 7.34 | 2.9 ± 9.83 |
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary (PCS) score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary (MCS) score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| PCS | 0.6 ± 4.89 | -1.8 ± 6.00 |
| MCS | 0.2 ± 7.93 | -0.8 ± 7.70 |
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary (PCS) score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary (MCS) score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| PCS | 0.8 ± 5.18 | -0.6 ± 4.04 |
| MCS | -0.8 ± 6.65 | 0.1 ± 7.71 |
The PGA for function is a 1-item questionnaire designed to assess participant's impression of the impact on their function related to uterine fibroids affected their usual activities and was completed on paper. The PGA for function was evaluated using a 5-point Likert scale (1 = No limitation at all; 5 = Extreme limitation) with higher numbers representing worse results. Endpoint values represent the worsening of function (deterioration), improvement of function (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (No limitation at all) to 5 (Extreme limitation) and a 4-category improvement represents a change from 5 (Extreme limitation) to 1 (No limitation at all).
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| 4 Category deterioration | 0 | 0 |
| 3 Category deterioration | 2 | 0 |
| 2 Category deterioration | 4 | 3 |
| 1 Category deterioration | 8 | 3 |
| No change | 63 | 14 |
| 1 Category improvement | 5 | 1 |
| 2 Category improvement | 2 | 0 |
| 3 Category improvement | 1 | 0 |
| 4 Category improvement | 1 | 0 |
The PGA for function is a 1-item questionnaire designed to assess participant's impression of the impact on their function related to uterine fibroids affected their usual activities and was completed on paper. The PGA for function was evaluated using a 5-point Likert scale (1 = No limitation at all; 5 = Extreme limitation) with higher numbers representing worse results. Endpoint values represent the worsening of function (deterioration), improvement of function (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (No limitation at all) to 5 (Extreme limitation) and a 4-category improvement represents a change from 5 (Extreme limitation) to 1 (No limitation at all).
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| 4 Category deterioration | 0 | 0 |
| 3 Category deterioration | 0 | 0 |
| 2 Category deterioration | 3 | 0 |
| 1 Category deterioration | 4 | 1 |
| No change | 54 | 7 |
| 1 Category improvement | 2 | 0 |
| 2 Category improvement | 1 | 0 |
| 3 Category improvement | 0 | 0 |
| 4 Category improvement | 1 | 0 |
The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids and was completed on paper. The PGA for symptoms was evaluated using a 5-point Likert scale (1 = Not severe; 5 = Extremely severe) with higher numbers representing worse results. Endpoint values represent the worsening of symptoms (deterioration), improvement of symptoms (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (Not severe) to 5 (Extremely severe) and a 4-category improvement represents a change from 5 (Extremely severe) to 1 (Not severe).
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| 4 Category deterioration | 0 | 0 |
| 3 Category deterioration | 1 | 1 |
| 2 Category deterioration | 4 | 3 |
| 1 Category deterioration | 8 | 3 |
| No change | 63 | 13 |
| 1 Category improvement | 5 | 0 |
| 2 Category improvement | 4 | 1 |
| 3 Category improvement | 0 | 0 |
| 4 Category improvement | 1 | 0 |
The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids and was completed on paper. The PGA for symptoms was evaluated using a 5-point Likert scale (1 = Not severe; 5 = Extremely severe) with higher numbers representing worse results. Endpoint values represent the worsening of symptoms (deterioration), improvement of symptoms (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (Not severe) to 5 (Extremely severe) and a 4-category improvement represents a change from 5 (Extremely severe) to 1 (Not severe).
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| 4 Category deterioration | 0 | 0 |
| 3 Category deterioration | 1 | 0 |
| 2 Category deterioration | 1 | 0 |
| 1 Category deterioration | 0 | 1 |
| No change | 58 | 7 |
| 1 Category improvement | 2 | 0 |
| 2 Category improvement | 2 | 0 |
| 3 Category improvement | 0 | 0 |
| 4 Category improvement | 1 | 0 |
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent work time missed due to uterine fibroids was calculated from hours missed due to uterine fibroids divided by the sum of hours missed due to uterine fibroids plus hours actually worked. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
| percentage score | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Work Time Missed Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period | 0.7 ± 10.22 | 3.9 ± 13.85 |
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent work time missed due to uterine fibroids was calculated from hours missed due to uterine fibroids divided by the sum of hours missed due to uterine fibroids plus hours actually worked. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
| percentage score | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Work Time Missed Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period | 0.5 ± 8.50 | 0 ± 0 |
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent impairment while working due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
| percentage score | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Impairment While Working Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period | -1.1 ± 16.20 | 1.8 ± 15.90 |
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent impairment while working due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
| percentage score | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Impairment While Working Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period | 0 ± 15.17 | 5.0 ± 12.25 |
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent overall work impairment due to uterine fibroid symptoms was calculated from the work time missed due to uterine fibroids plus the value calculated from 1 minus the work time missed value multiplied by the value for impairment while working due to uterine fibroids. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
| percentage score | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Overall Work Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period | -0.8 ± 20.05 | 3.2 ± 10.56 |
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent overall work impairment due to uterine fibroid symptoms was calculated from the work time missed due to uterine fibroids plus the value calculated from 1 minus the work time missed value multiplied by the value for impairment while working due to uterine fibroids. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
| percentage score | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Overall Work Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period | 0.6 ± 19.13 | 6.0 ± 13.42 |
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent activity impairment due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented activity) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
| percentage score | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Activity Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period | -0.5 ± 21.10 | 4.5 ± 19.32 |
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent activity impairment due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages (0 to 100%), with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
| percentage score | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Activity Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period | -1.3 ± 18.90 | 5.0 ± 10.69 |
Assessed using the UFS-QOL which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer the following questions: heavy bleeding during your menstrual period (Question 1), passing blood clots during your menstrual period (Question 2), and feeling tightness or pressure in your pelvic area (Question 5). Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1, 2, and 5 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater distress and a lower score of less distress (high scores = bad).
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In The UFS-QoL Bleeding And Pelvic Discomfort Score During The Randomized Treatment Period | 3.4 ± 20.27 | 17.5 ± 24.99 |
Assessed using the UFS-QOL which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer the following questions: heavy bleeding during your menstrual period (Question 1), passing blood clots during your menstrual period (Question 2), and feeling tightness or pressure in your pelvic area (Question 5). Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1, 2, and 5 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater distress and a lower score of less distress (high scores = bad).
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Change From Week 52/Baseline In The UFS-QoL Bleeding And Pelvic Discomfort Score During The Randomized Treatment Period | -0.5 ± 17.85 | -6.3 ± 43.36 |
Assessed using the UFS-QOL, which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1 through 8 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater symptom severity and a lower score of lower symptom severity (negative score = improvement).
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Original: Change From Week 52/Baseline In The UFS-QoL Symptom Severity Score During The Randomized Treatment Period | 2.2 ± 18.16 | 14.1 ± 21.07 |
Assessed using the UFS-QOL, which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1 through 8 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater symptom severity and a lower score of lower symptom severity (negative score = improvement).
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| New: Change From Week 52/Baseline In The UFS-QoL Symptom Severity Score During The Randomized Treatment Period | 0.1 ± 15.94 | -4.3 ± 42.22 |
Assessed using the UFS-QOL which, is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. Items are scored on a 5-point scale, ranging from "none of the time" to "all of the time." The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Questions 9 through 37 were used to calculate the total scores and the following subscales: concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function. All raw scores are transformed to normalized scores with a range of possible values from 0 to 100. A positive score indicates improvement.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Concern | -2.4 ± 24.38 | -13.6 ± 27.76 |
| Activities | -1.7 ± 17.46 | -11.7 ± 26.10 |
| Revised activities | -2.3 ± 18.66 | -13.3 ± 27.13 |
| Energy/mood | -0.1 ± 17.30 | -3.9 ± 23.69 |
| Control | 0.2 ± 15.60 | -3.6 ± 23.03 |
| Self-conscious | 0 ± 21.66 | -11.5 ± 16.77 |
| Sexual function | 1.0 ± 28.77 | -16.7 ± 43.72 |
| Total Score | -0.8 ± 16.79 | -9.1 ± 22.37 |
Assessed using the UFS-QOL which, is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. Items are scored on a 5-point scale, ranging from "none of the time" to "all of the time." The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Questions 9 through 37 were used to calculate the total scores and the following subscales: concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function. All raw scores are transformed to normalized scores with a range of possible values from 0 to 100. A positive score indicates improvement.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Concern | 2.2 ± 21.45 | 11.9 ± 41.40 |
| Activities | 0.9 ± 16.74 | 8.5 ± 42.00 |
| Revised activities | 0.6 ± 16.02 | 7.5 ± 42.59 |
| Energy/mood | 1.6 ± 17.41 | 8.0 ± 44.35 |
| Control | 1.7 ± 15.19 | 9.4 ± 39.05 |
| Self-conscious | -2.8 ± 19.94 | 3.1 ± 44.53 |
| Sexual function | 0.8 ± 26.51 | 3.1 ± 52.08 |
| Total Score | 1.1 ± 15.25 | 8.2 ± 42.12 |
Blood samples were collected from participants for estradiol measurements and were analyzed using a standard clinical methodology. The change from Week 52/Baseline in estradiol concentration at Week 56 was presented in this outcome.
| pg/mL | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Predose Concentration Of Estradiol At Week 56 | 2.03 ± 31.605 | 62.54 ± 77.661 |
Assessed by percentage of participants with AEs and serious AEs (SAEs). An AE was defined as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or a congenital anomaly/birth defect. Events of heavy menstrual bleeding were only reported if the event met criteria as an SAE. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Any AEs | 68 | 72 |
| Leading to study treatment discontinuation | 2 | 3 |
| Leading to study treatment interruption | 1 | 0 |
| Related to study drug | 26 | 27 |
| Grade 3 or higher | 3 | 5 |
| Grade 3 or higher related to study drug | 0 | 2 |
| SAEs | 2 | 2 |
| Serious and related to study drug | 0 | 1 |
| Serious and leading to treatment discontinuation | 1 | 1 |
| Fatal outcome | 0 | 0 |
Assessed by dual-energy X-ray absorptiometry scan at the lumbar spine (L1-L4), total hip \[presented separately\], and femoral neck (same leg within each participant) \[presented separately\] at each designated timepoints. The least squares means and their 95% CI were based on analysis of covariance model with treatment, stratification factors, race as fixed factors, and age at Week 52/Baseline, Week 52/Baseline BMD value, and body mass index at Week 52/Baseline as covariates.
| percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Percent Change From Week 52/Baseline In BMD At Lumbar Spine (L1-L4) | 0.81 (0.20 to 1.41) | 0.10 (-0.52 to 0.71) |
Assessed by dual-energy X-ray absorptiometry scan at the lumbar spine (L1-L4) \[presented separately\], total hip, and femoral neck (same leg within each participant) at each designated timepoints. The least squares means and their 95% CI were based on analysis of covariance model with treatment, stratification factors, race as fixed factors, and age at Week 52/Baseline, Week 52/Baseline BMD value, and body mass index at Week 52/Baseline as covariates.
| percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Total Hip | 0.34 (-0.25 to 0.93) | -0.13 (-0.73 to 0.47) |
| Femoral Neck | -0.19 (-1.14 to 0.77) | -0.76 (-1.74 to 0.21) |
Collected over Week 52/Baseline up to Week 104. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | 0/116 (0%) | 2/116 (1.7%) | 29/116 (25%) |
| Placebo (Group B) | 0/112 (0%) | 2/112 (1.8%) | 45/112 (40.2%) |
| Event | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| Myxoid liposarcomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/116 | 1/112 |
| Transient global amnesiaNervous system disorders | 0/116 | 1/112 |
| AnaemiaBlood and lymphatic system disorders | 1/116 | 0/112 |
| Breast cancer stage IINeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/116 | 0/112 |
| Event | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) |
|---|---|---|
| NasopharyngitisInfections and infestations | 13/116 | 12/112 |
| DysmenorrhoeaReproductive system and breast disorders | 2/116 | 8/112 |
| Hot flushVascular disorders | 2/116 | 8/112 |
| HeadacheNervous system disorders | 8/116 | 5/112 |
| HypertensionVascular disorders | 2/116 | 6/112 |
| Upper respiratory tract infectionInfections and infestations | 2/116 | 6/112 |
mITT population: all participants randomized to treatment who had taken at least one dose of study treatment (relugolix plus E2/NETA or placebo).
| Age, Continuous(years) | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) | Total |
|---|---|---|---|
| Mean | 43.3 ± 5.58 | 44.2 ± 4.39 | 43.8 ± 5.04 |
| Sex/Gender, Customized(Participants) | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) | Total |
|---|---|---|---|
| Female | 115 | 113 | 228 |
| Ethnicity (NIH/OMB)(Participants) | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) | Total |
|---|---|---|---|
| Hispanic or Latino | 29 | 29 | 58 |
| Not Hispanic or Latino | 85 | 84 | 169 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 1 | 2 |
| Black or African American | 49 | 57 | 106 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| White | 63 | 52 | 115 |
| Other | 1 | 2 | 3 |
| Multiple | 0 | 0 | 0 |
| Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) | Total |
|---|---|---|---|
| Hungary | 4 | 8 | 12 |
| United States | 74 | 74 | 148 |
| Czechia | 2 | 1 | 3 |
| Brazil | 5 | 2 | 7 |
| Poland | 14 | 12 | 26 |
| Italy | 6 | 3 | 9 |
| South Africa | 7 | 6 | 13 |
| Chile | 3 | 8 | 11 |
| Bone Mineral Density (BMD) at Week 52/Baseline(g/cm^2) | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) | Total |
|---|---|---|---|
| Lumbar Spine (L1-L4) | 1.18 ± 0.173 | 1.20 ± 0.147 | 1.19 ± 0.160 |
| Total hip | 1.04 ± 0.151 | 1.04 ± 0.140 | 1.04 ± 0.145 |
| Femoral neck | 0.97 ± 0.186 | 0.97 ± 0.164 | 0.97 ± 0.175 |
| Mean Menstrual Blood Loss (MBL) Volume at Week 52/ Baseline(mL) | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) | Total |
|---|---|---|---|
| Mean | 8.67 ± 30.943 | 6.40 ± 20.073 | 7.55 ± 26.095 |
| Hemoglobin at Week 52/Baseline(g/dL) | Relugolix Plus E2/NETA (Group A) | Placebo (Group B) | Total |
|---|---|---|---|
| Mean | 13.00 ± 1.405 | 12.81 ± 1.305 | 12.91 ± 1.356 |
7 further baseline measures are reported on the registry.
Showing the first 100 of 104 sites across 8 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2018 to primary completion in Feb 2021, 28 months.
Results were first posted in Jun 2024, 3 years 4 months after primary completion.
Of 25 phase 3 interventional studies under Leiomyoma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 41. This study's 28 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Relugolix