A Phase 3 interventional study of Relugolix and Estradiol/norethindrone acetate in Heavy Menstrual Bleeding and Uterine Fibroid, sponsored by Myovant Sciences GmbH. Completed at 110 sites in 6 countries. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-04-19.
Sponsored by Myovant Sciences GmbH (part of Sumitomo Pharma Co., Ltd.) · Phase 3, Interventional, and Treatment
Among 85 studies in Menorrhagia with a site in United States — 8 open to participants now, 10 under way, none of them phase 3. Menorrhagia · United States.
Among the 85 studies in Menorrhagia with a site in United States, this one is the 11th largest by enrollment of the 71 interventional ones that give a count, is one of 8 that started in 2017, is one of 22 in phase 3, and was the 49th registered.
206 studies on the registry are indexed under Menorrhagia; 35 are open to participants now.
Browse Menorrhagia studies →8 of the 85 studies in Menorrhagia with a site in United States are open now. Recruiting first, the newest first:
Alnylam Pharmaceuticals · Sites in United States, Netherlands, Sweden and 2 more countries
Spark Biomedical, Inc. · Sites in United States
Oregon Health and Science University · Sites in United States
University of Colorado, Colorado Springs · Sites in United States
Channel Medsystems · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 23 Menorrhagia studies recruiting now, 4 (17%) set no upper age limit and 19 (83%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 50 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.
85 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 5 · Phase 3 22 · Phase 4 16
First in 2001; this study’s year is marked. 8 started in 2017.
This study's enrollment of 388 is above the median of 95 across 149 interventional studies indexed under Menorrhagia.
Median enrollment 82 across the 71 interventional studies, 256 across the 14 observational. Of the 66 that completed or were terminated, 40 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
43 of 85 have an industry lead sponsor. The 10 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 Menorrhagia — fewer than ten, so there is no comparison to draw.
3 of the studies in Menorrhagia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT07575308Alnylam PharmaceuticalsHMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB | 2027-06-30 |
| NCT07326722Spark Biomedical, Inc.Delivering tAN to Reduce HMB: The LUNA Study | 2027-08-31 |
Among the 85 studies in Menorrhagia with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral daily relugolix 40 mg co-administered with low-dose E2 and NETA (Group A) and 12 weeks of daily oral relugolix 40 mg alone followed by 12 weeks of daily oral relugolix 40 mg co-administered with low-dose E2 and NETA (Group B) compared with 24 weeks of placebo (Group C).
All participants completing the Week 24 visit, including women randomized to placebo, were offered the opportunity to enroll in an open-label extension study in which all eligible participants will receive relugolix co-administered with low-dose E2 and NETA. Participants who did not enroll into the extension study had a follow-up visit approximately 30 days after the end of treatment (that is, after the participant's last dose of study medication).
Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and assessments of bone mineral density.
Key Inclusion Criteria:
Key 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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relugolix co-administered with E2/NETA for 24 weeks.
Drug: Relugolix · Drug: Estradiol/norethindrone acetate
Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.
Drug: Relugolix · Drug: Estradiol/norethindrone acetate · Drug: Estradiol/norethindrone acetate placebo
Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.
Drug: Estradiol/norethindrone acetate placebo · Drug: Relugolix placebo
Relugolix (40 mg) tablet administered orally once daily.
Also known as: TAK-385, MVT-601
Drug pages: Estradiol · Norethindrone Acetate
E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.
Also known as: E2/NETA, low-dose hormonal add-back
E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA
A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 24). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 24/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented. As per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: From Baseline up to last 35 days of treatment (up to Week 24)
Percentage Of Participants With Amenorrhea Over The Last 35 Days Of Treatment
Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits: 1. No feminine product returned due to reported amenorrhea; 2. No feminine product returned due to reports of spotting/negligible bleeding coupled with electronic diary (eDiary) data indicating infrequent non-cyclic bleeding/spotting; 3. Feminine product collection with a negligible observed MBL volume coupled with eDiary data indicating infrequent non-cyclic bleeding/spotting. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: From Baseline up to last 35 days of treatment (up to Week 24)
Percent Change From Baseline At Week 24 In MBL Volume
MBL volume was measured using the alkaline hematin method. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Percentage Of Participants With A Hemoglobin Level ≤ 10.5 g/dL At Baseline Who Achieved An Increase Of > 2 g/dL From Baseline At Week 24
Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤ 10.5 gram (g)/deciliter (dL) at Baseline and reported at Week 24. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA with placebo arms are presented.
Time frame: From Baseline up to Week 24
Percentage Of Participants With A Maximum NRS Score ≤ 1 For Uterine Fibroid-Associated Pain Over The Last 35 Days Of Treatment
Uterine fibroid-associated pain was assessed by a pain numerical rating scale (NRS). The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain). Participants were asked to document, in an e-Diary, the worst pain associated with their uterine fibroids that they experienced during the last 24 hours, every day until the end of study drug administration. Pain evaluable participants, defined as those who had maximum NRS score ≥ 4 at Baseline and had at least 28 days (80% of the last 35 days of treatment) of pain scores recorded in the e-Diary, were analyzed. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: From Baseline up to Week 24
Percent Change From Baseline At Week 24 In Primary Uterine Fibroid Volume
The volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Percent Change From Baseline At Week 24 In Uterine Volume
The volume of the uterus was measured by transvaginal or transabdominal ultrasound. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline At Week 24 In UFS-QoL Bleeding And Pelvic Discomfort Scale Score As Measured By The UFS-QoL (Q1, Q2, Q5)
The Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) Bleeding and Pelvic Discomfort (BPD) Scale has been derived from the UFS-QoL Symptoms Scale. The scale consists of the following 3 symptoms proximal to uterine fibroids: Heavy bleeding during your menstrual period (Question \[Q\] 1), passing blood clots during your menstrual period (Q2), and feeling tightness or pressure in your pelvic area (Q5). raw scores were transformed to a normalized score: Transformed Score = \[(Actual raw score - lowest possible raw score)/(Possible raw score range)\] \* 100 Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. As per the study objective, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only these two arms are presented.
Time frame: Baseline, Week 24
Percent Change From Baseline At Week 12 In Bone Mineral Density At The Lumbar Spine (L1 To L4), As Assessed By DXA
Bone mineral density (BMD) was assessed by dual-energy x-ray absorptiometry (DXA) at the lumbar spine (L1, L2, L3, and L4) at Baseline and at Week 12. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. As per the objective of the study, the pre-specified secondary analyses compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below.
Time frame: Baseline, Week 12
Percent Change From Baseline At Week 24 In Bone Mineral Density At The Lumbar Spine (L1 To L4), Total Hip, And Femoral Neck
BMD was assessed by DXA at the lumbar spine (L1, L2, L3, and L4), total hip, and femoral neck at Baseline and at Week 24. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 12
An adverse event was defined as an 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. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term. Reported CI based on exact binomial 95% CI (Clopper-Pearson). As per the objective of the study, this secondary analysis compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below.
Time frame: Baseline through Week 12
Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 24
An adverse event was defined as an 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. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term. Reported percentages based on the total number of participants in each treatment group. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline through Week 24
Predose Trough Concentrations Of Relugolix And Norethindrone (NET) In The Relugolix Plus E2/NETA Group At Week 24
Blood samples for determination of relugolix and NET plasma concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology. Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.
Time frame: Week 24
Predose Trough Concentrations Of E2 In The Relugolix Plus E2/NETA Group At Week 24
Blood samples for determination of E2 serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology. Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.
Time frame: Week 24
Change From Baseline At Week 24 In Predose Concentrations Of Estradiol In The Relugolix Plus E2/NETA Group
Blood samples for determination of serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology. Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.
Time frame: Baseline, Week 24
Time To MBL Response
Defined as the time to achieve an MBL volume of \< 80 mL and a ≥ 50% reduction from Baseline MBL volume as measured by the alkaline hematin method. MBL volume was measured using the alkaline hematin method. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: From Baseline through Week 24
Sustained Amenorrhea Rate (No Or Negligible Bleeding)
Sustained amenorrhea is defined as participants time to achieve and maintain amenorrhea until the date of last study drug. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Week 24
Time To Achieving Sustained Amenorrhea (No Or Negligible Bleeding)
Sustained amenorrhea status as determined based on time to achieve and maintain amenorrhea status. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: From Baseline through Week 24
Time To Achieving Amenorrhea (No Or Negligible Bleeding)
Time to amenorrhea was defined as the weeks from date of first dose of study drug to the start of amenorrhea. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: From Baseline through Week 24
Number Of Participants With Hemoglobin ≤ 10.5 g/dL At Baseline And Achieved An Increase Of > 2 g/dL At Week 24
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: From Baseline through Week 24
Percent Change From Baseline In Hemoglobin For Women With a Hemoglobin ≤ 10.5 g/dL At Baseline
LS means and p-value for test of difference is relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Week 24
Number Of Participants With Hemoglobin Increase Of ≥ 1 g/dL From Baseline To Week 24 Among Those With Below Lower Limit Of Normal
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Week 24
Change From Baseline At Week 24 In The UFS-QoL Symptom Severity Scale Score
Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline At Week 24 In The UFS-QoL Activities Scale Score
Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline At Week 24 In The UFS-QoL Revised Activities Scale Score
Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline In UFS-QoL Score By Health-Related Quality Of Life Total Score
The UFS-QoL total score was the sum of 6 subscales (concern, activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Number Of Responders With At Least 20 Points Increase From Baseline At Week 24 In UFS-QoL Revised Activities Scale Score
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: From Baseline through Week 24
Change From Baseline In UFS-QoL Bleeding And Pelvic Discomfort Scale Score
The Bleeding and Pelvic Discomfort Scale consists of 3 items proximal to uterine fibroids that are experienced by most patients (heavy bleeding during the menstrual period \[Question 1\], passing blood clots during the menstrual period \[Question 2\], and feeling tightness or pressure in the pelvic area \[Question 5\]).Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Number Of Responders With At Least 20 Points Decrease In UFS-QoL Bleeding And Pelvic Discomfort Scale Score
A Responder was defined as meeting a meaningful change threshold, set as a 20-point change from Baseline, in the Bleeding And Pelvic Discomfort Scale at Week 24 on the transformed score. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Physical Activities Based On UFS-QoL Question 11
Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Social Activities Based On UFS-QoL Question 20
Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline At Week 24 In Embarrassment Caused By Uterine Fibroids Based On UFS-QoL Question 29
Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline At Week 24 In Symptoms Assessed Using The Patient Global Assessment (PGA) Questionnaire
The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. 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. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \[1\], mild limitation \[2\], moderate limitation \[3\], quite a bit of limitation \[4\], and extreme limitation \[5\]). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline At Week 24 In Function Assessed Using The PGA Questionnaire
The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. 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. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \[1\], mild limitation \[2\], moderate limitation \[3\], quite a bit of limitation \[4\], and extreme limitation \[5\]). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Participants Achieving Improvement From Baseline In The PGA Questionnaire For Symptoms From Baseline At Week 24
The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \[1\], mild limitation \[2\], moderate limitation \[3\], quite a bit of limitation \[4\], and extreme limitation \[5\]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: From Baseline through Week 24
Participants Achieving Improvement From Baseline In The PGA Questionnaire For Uterine Fibroid-related Function From Baseline At Week 24
The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \[1\], mild limitation \[2\], moderate limitation \[3\], quite a bit of limitation \[4\], and extreme limitation \[5\]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: From Baseline through Week 24
Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Physical Activities
The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Social Activities
The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Number Of Participants Who Achieved A Maximum NRS Score ≤ 1 For Uterine Fibroid-associated Pain Over The Last 35 Days Of Treatment Who Had Maximum Pain Scores ≥ 4 During The 35 Days Prior To Randomization
Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: From Baseline up to the last 35 days of treatment (up to 24 weeks)
Number Of Participants With A ≥ 30% Reduction in NRS Score From Baseline to Last 35 Days of Treatment Who Had Maximum Pain Scores ≥ 4 At Baseline
Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline In Luteinizing Serum Concentration At Week 24
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline In Follicle Stimulating Serum Concentration At Week 24
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline In E2 Serum Concentration At Week 24
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
Change From Baseline In Progesterone Serum Concentration At Week 24
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
Time frame: Baseline, Week 24
A total of 80 study centers globally were initiated in this study, including centers in the United States, Brazil, Italy, Poland, South Africa, and the United Kingdom.
| Milestone | Relugolix Plus Estradiol (E2)/ Norethindrone Acetate (NETA) (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Started | 128 | 132 | 128 |
| Received at least 1 dose of study drug | 128 | 132 | 127 |
| Completed | 100 | 103 | 105 |
| Not completed | 28 | 29 | 23 |
| Withdrew: Discontinued due to ae (not dosed) | 0 | 0 | 1 |
| Withdrew: Other | 5 | 3 | 1 |
| Withdrew: Lack of efficacy | 4 | 0 | 3 |
| Withdrew: Protocol deviation | 1 | 0 | 0 |
| Withdrew: Pregnancy | 0 | 0 | 1 |
| Withdrew: Adverse event | 7 | 18 | 5 |
| Withdrew: Withdrawal by subject | 10 | 3 | 7 |
| Withdrew: Lost to follow-up | 1 | 5 | 5 |
A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 24). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 24/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented. As per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA | 73.4 (64.91 to 80.85) | 18.9 (12.50 to 26.80) |
Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits: 1. No feminine product returned due to reported amenorrhea; 2. No feminine product returned due to reports of spotting/negligible bleeding coupled with electronic diary (eDiary) data indicating infrequent non-cyclic bleeding/spotting; 3. Feminine product collection with a negligible observed MBL volume coupled with eDiary data indicating infrequent non-cyclic bleeding/spotting. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Percentage Of Participants With Amenorrhea Over The Last 35 Days Of Treatment | 52.34 (43.34 to 61.24) | 5.51 (2.24 to 11.03) |
MBL volume was measured using the alkaline hematin method. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Percent Change From Baseline At Week 24 In MBL Volume | -84.3 (-93.5 to -75.0) | -23.2 (-32.2 to -14.1) |
Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤ 10.5 gram (g)/deciliter (dL) at Baseline and reported at Week 24. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA with placebo arms are presented.
| Percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Percentage Of Participants With A Hemoglobin Level ≤ 10.5 g/dL At Baseline Who Achieved An Increase Of > 2 g/dL From Baseline At Week 24 | 50.0 (31.30 to 68.70) | 21.74 (7.46 to 43.70) |
Uterine fibroid-associated pain was assessed by a pain numerical rating scale (NRS). The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain). Participants were asked to document, in an e-Diary, the worst pain associated with their uterine fibroids that they experienced during the last 24 hours, every day until the end of study drug administration. Pain evaluable participants, defined as those who had maximum NRS score ≥ 4 at Baseline and had at least 28 days (80% of the last 35 days of treatment) of pain scores recorded in the e-Diary, were analyzed. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Percentage Of Participants With A Maximum NRS Score ≤ 1 For Uterine Fibroid-Associated Pain Over The Last 35 Days Of Treatment | 43.10 (30.16 to 56.77) | 10.14 (4.18 to 19.79) |
The volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Percent Change From Baseline At Week 24 In Primary Uterine Fibroid Volume | -12.4 (-23.5 to -1.4) | -0.3 (-10.9 to 10.4) |
The volume of the uterus was measured by transvaginal or transabdominal ultrasound. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Percent Change From Baseline At Week 24 In Uterine Volume | -12.9 (-19.0 to -6.9) | 2.2 (-3.7 to 8.1) |
The Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) Bleeding and Pelvic Discomfort (BPD) Scale has been derived from the UFS-QoL Symptoms Scale. The scale consists of the following 3 symptoms proximal to uterine fibroids: Heavy bleeding during your menstrual period (Question \[Q\] 1), passing blood clots during your menstrual period (Q2), and feeling tightness or pressure in your pelvic area (Q5). raw scores were transformed to a normalized score: Transformed Score = \[(Actual raw score - lowest possible raw score)/(Possible raw score range)\] \* 100 Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. As per the study objective, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only these two arms are presented.
| units on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline At Week 24 In UFS-QoL Bleeding And Pelvic Discomfort Scale Score As Measured By The UFS-QoL (Q1, Q2, Q5) | -45.0 (-50.7 to -39.3) | -16.1 (-21.6 to -10.5) |
Bone mineral density (BMD) was assessed by dual-energy x-ray absorptiometry (DXA) at the lumbar spine (L1, L2, L3, and L4) at Baseline and at Week 12. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. As per the objective of the study, the pre-specified secondary analyses compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below.
| percent change | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) |
|---|---|---|
| Percent Change From Baseline At Week 12 In Bone Mineral Density At The Lumbar Spine (L1 To L4), As Assessed By DXA | -0.470 ± 0.2915 | -1.995 ± 0.2848 |
BMD was assessed by DXA at the lumbar spine (L1, L2, L3, and L4), total hip, and femoral neck at Baseline and at Week 24. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Lumbar Spine (L1 to L4) | -0.356 ± 0.2929 | 0.052 ± 0.2896 |
| Total Hip | 0.023 ± 0.2461 | 0.549 ± 0.2407 |
| Femoral Neck | -0.262 ± 0.4466 | 0.307 ± 0.4395 |
An adverse event was defined as an 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. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term. Reported CI based on exact binomial 95% CI (Clopper-Pearson). As per the objective of the study, this secondary analysis compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) |
|---|---|---|
| Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 12 | 10.94 (6.11 to 17.67) | 36.36 (28.17 to 45.18) |
An adverse event was defined as an 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. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term. Reported percentages based on the total number of participants in each treatment group. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 24 | 14.8 | 9.4 |
Blood samples for determination of relugolix and NET plasma concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology. Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.
| ng/mL | Relugolix Plus E2/NETA (Group A) |
|---|---|
| Relugolix | 2.13 ± 2.144 |
| NET | 0.33 ± 0.369 |
Blood samples for determination of E2 serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology. Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.
| pg/mL | Relugolix Plus E2/NETA (Group A) |
|---|---|
| Predose Trough Concentrations Of E2 In The Relugolix Plus E2/NETA Group At Week 24 | 48.34 ± 59.660 |
Blood samples for determination of serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology. Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.
| pg/mL | Relugolix Plus E2/NETA (Group A) |
|---|---|
| Change From Baseline At Week 24 In Predose Concentrations Of Estradiol In The Relugolix Plus E2/NETA Group | -22.95 ± 84.005 |
Defined as the time to achieve an MBL volume of \< 80 mL and a ≥ 50% reduction from Baseline MBL volume as measured by the alkaline hematin method. MBL volume was measured using the alkaline hematin method. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| weeks | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Time To MBL Response | 8.3 (8.1 to 8.7) | 25.1 (24.1 to 28.1) |
Sustained amenorrhea is defined as participants time to achieve and maintain amenorrhea until the date of last study drug. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Sustained Amenorrhea Rate (No Or Negligible Bleeding) | 67 | 7 |
Sustained amenorrhea status as determined based on time to achieve and maintain amenorrhea status. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| weeks | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Time To Achieving Sustained Amenorrhea (No Or Negligible Bleeding) | 11.3 (5.1 to 18.6) | NA (NA to NA) |
Time to amenorrhea was defined as the weeks from date of first dose of study drug to the start of amenorrhea. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| weeks | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Time To Achieving Amenorrhea (No Or Negligible Bleeding) | 5.3 (5.0 to 9.1) | NA (NA to NA) |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Number Of Participants With Hemoglobin ≤ 10.5 g/dL At Baseline And Achieved An Increase Of > 2 g/dL At Week 24 | 15 | 5 |
LS means and p-value for test of difference is relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| percent change | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Percent Change From Baseline In Hemoglobin For Women With a Hemoglobin ≤ 10.5 g/dL At Baseline | 20.8 ± 3.05 | 10.0 ± 3.53 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Number Of Participants With Hemoglobin Increase Of ≥ 1 g/dL From Baseline To Week 24 Among Those With Below Lower Limit Of Normal | 34 | 17 |
Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline At Week 24 In The UFS-QoL Symptom Severity Scale Score | -30.9 ± 2.61 | -10.5 ± 2.55 |
Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline At Week 24 In The UFS-QoL Activities Scale Score | 44.4 ± 3.06 | 14.6 ± 2.99 |
Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| units on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline At Week 24 In The UFS-QoL Revised Activities Scale Score | 45.8 ± 3.19 | 15.1 ± 3.12 |
The UFS-QoL total score was the sum of 6 subscales (concern, activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| units on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline In UFS-QoL Score By Health-Related Quality Of Life Total Score | 38.0 ± 2.80 | 12.8 ± 2.73 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Number Of Responders With At Least 20 Points Increase From Baseline At Week 24 In UFS-QoL Revised Activities Scale Score | 78 | 45 |
The Bleeding and Pelvic Discomfort Scale consists of 3 items proximal to uterine fibroids that are experienced by most patients (heavy bleeding during the menstrual period \[Question 1\], passing blood clots during the menstrual period \[Question 2\], and feeling tightness or pressure in the pelvic area \[Question 5\]).Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline In UFS-QoL Bleeding And Pelvic Discomfort Scale Score | -45.0 ± 2.88 | -16.1 ± 2.81 |
A Responder was defined as meeting a meaningful change threshold, set as a 20-point change from Baseline, in the Bleeding And Pelvic Discomfort Scale at Week 24 on the transformed score. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Number Of Responders With At Least 20 Points Decrease In UFS-QoL Bleeding And Pelvic Discomfort Scale Score | 79 | 35 |
Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Physical Activities Based On UFS-QoL Question 11 | -2.1 ± 0.14 | -0.6 ± 0.13 |
Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Social Activities Based On UFS-QoL Question 20 | -1.7 ± 0.14 | -0.7 ± 0.14 |
Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline At Week 24 In Embarrassment Caused By Uterine Fibroids Based On UFS-QoL Question 29 | -1.5 ± 0.14 | -0.4 ± 0.14 |
The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. 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. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \[1\], mild limitation \[2\], moderate limitation \[3\], quite a bit of limitation \[4\], and extreme limitation \[5\]). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline At Week 24 In Symptoms Assessed Using The Patient Global Assessment (PGA) Questionnaire | -2.1 ± 0.14 | -0.8 ± 0.13 |
The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. 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. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \[1\], mild limitation \[2\], moderate limitation \[3\], quite a bit of limitation \[4\], and extreme limitation \[5\]). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline At Week 24 In Function Assessed Using The PGA Questionnaire | -1.6 ± 0.16 | -0.5 ± 0.15 |
The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \[1\], mild limitation \[2\], moderate limitation \[3\], quite a bit of limitation \[4\], and extreme limitation \[5\]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| 1 Category improvement (-1) | 14 | 28 |
| 2 Category improvement (-2) | 29 | 14 |
| 3 Category improvement (-3) | 22 | 1 |
| 4 Category improvement (-4) | 8 | 5 |
The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \[1\], mild limitation \[2\], moderate limitation \[3\], quite a bit of limitation \[4\], and extreme limitation \[5\]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| 1 Category improvement (-1) | 21 | 16 |
| 2 Category improvement (-2) | 18 | 9 |
| 3 Category improvement (-3) | 23 | 4 |
| 4 Category improvement (-4) | 2 | 4 |
The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Physical Activities | -2.0 ± 0.14 | -0.9 ± 0.14 |
The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Social Activities | -1.9 ± 0.14 | -0.8 ± 0.14 |
Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Number Of Participants Who Achieved A Maximum NRS Score ≤ 1 For Uterine Fibroid-associated Pain Over The Last 35 Days Of Treatment Who Had Maximum Pain Scores ≥ 4 During The 35 Days Prior To Randomization | 33 | 11 |
Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| Participants | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Number Of Participants With A ≥ 30% Reduction in NRS Score From Baseline to Last 35 Days of Treatment Who Had Maximum Pain Scores ≥ 4 At Baseline | 42 | 27 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| IU/L | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline In Luteinizing Serum Concentration At Week 24 | -1.90 ± 20.496 | 3.62 ± 12.524 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| IU/L | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline In Follicle Stimulating Serum Concentration At Week 24 | -6.25 ± 14.779 | 0.10 ± 11.024 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| pg/mL | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline In E2 Serum Concentration At Week 24 | -22.95 ± 84.005 | 51.72 ± 145.346 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
| ng/mL | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|
| Change From Baseline In Progesterone Serum Concentration At Week 24 | -0.05 ± 2.262 | 3.00 ± 4.802 |
Collected over From Baseline to Week 24. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | 0/128 (0%) | 7/128 (5.5%) | 32/128 (25%) |
| Relugolix Plus Delayed E2/NETA (Group B) | 0/132 (0%) | 3/132 (2.3%) | 62/132 (47%) |
| Placebo (Group C) | 0/127 (0%) | 2/127 (1.6%) | 33/127 (26%) |
| Event | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Acute psychosisPsychiatric disorders | 0/128 | 0/132 | 1/127 |
| PneumoniaInfections and infestations | 0/128 | 0/132 | 1/127 |
| Avulsion fractureInjury, poisoning and procedural complications | 1/128 | 0/132 | 0/127 |
| Ankle fractureInjury, poisoning and procedural complications | 1/128 | 1/132 | 0/127 |
| Uterine myoma expulsionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/128 | 0/132 | 0/127 |
| uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/128 | 0/132 | 0/127 |
| Vitreous detachmentEye disorders | 1/128 | 0/132 | 0/127 |
| HaematemesisGastrointestinal disorders | 1/128 | 0/132 | 0/127 |
| MenorrhagiaReproductive system and breast disorders | 1/128 | 0/132 | 0/127 |
| Pelvic painReproductive system and breast disorders | 1/128 | 0/132 | 0/127 |
| Event | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Hot flushVascular disorders | 14/128 | 47/132 | 10/127 |
| HeadacheNervous system disorders | 14/128 | 14/132 | 19/127 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/128 | 0/132 | 7/127 |
| HypertensionVascular disorders | 7/128 | 3/132 | 0/127 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/128 | 7/132 | 4/127 |
| Upper respiratory tract infectionInfections and infestations | 1/128 | 7/132 | 3/127 |
All participants who were enrolled and randomized in the study.
| Age, Categorical(Participants) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 128 | 132 | 128 | 388 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Mean | 42.5 ± 4.99 | 41.3 ± 5.39 | 42.2 ± 5.70 | 42.0 ± 5.38 |
| Sex: Female, Male(Participants) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Female | 128 | 132 | 128 | 388 |
| Male | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 5 | 1 | 8 |
| Asian | 0 | 2 | 2 | 4 |
| Black or African American | 59 | 67 | 66 | 192 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| White | 64 | 53 | 56 | 173 |
| Other Race | 2 | 1 | 1 | 4 |
| Multiple Race | 1 | 4 | 2 | 7 |
| Race Not reported | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 92 | 99 | 104 | 295 |
| Hispanic or Latino | 34 | 33 | 23 | 90 |
| Ethnicity Not reported | 2 | 0 | 1 | 3 |
| Region of Enrollment(participants) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| United States | 98 | 101 | 99 | 298 |
| Brazil | 3 | 5 | 3 | 11 |
| Poland | 12 | 16 | 22 | 50 |
| Italy | 10 | 7 | 3 | 20 |
| South Africa | 4 | 3 | 0 | 7 |
| United Kingdom | 1 | 0 | 1 | 2 |
Showing the first 100 of 110 sites across 6 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2017 to primary completion in Apr 2019, 24 months.
Results were first posted in Apr 2022, 2 years 11 months after primary completion. A results delay was requested in Apr 2020.
Of 17 phase 3 interventional studies under Menorrhagia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 35. This study's 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Relugolix