A Phase 3 interventional study of Relugolix and Estradiol/norethindrone acetate in Endometriosis, sponsored by Myovant Sciences GmbH. Completed at 169 sites in 20 countries. Open to female participants aged 18 Years to 51 Years. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by Myovant Sciences GmbH (part of Sumitomo Pharma Co., Ltd.) · Phase 3, Interventional, and Treatment
Among 10 studies testing relugolix in Endometriosis — 2 open to participants now, 2 under way, 2 of them phase 3. relugolix · Endometriosis.
Among the 10 studies testing relugolix in Endometriosis, this one is the 3rd largest by enrollment, is the only one that started in 2018, is one of 7 in phase 3, and was the 6th registered.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
Browse Endometriosis studies →2 of the 10 studies testing relugolix in Endometriosis are open now, in 1 country. Recruiting first, the newest first:
Main Line Health · Sites in United States
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 176 Endometriosis studies recruiting now, 51 (29%) set no upper age limit and 123 (70%) stop at 75 or younger; 18 take children under 18; 39 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 802 is above the median of 67 across 540 interventional studies indexed under Endometriosis.
Median enrollment 555 across the 10 interventional studies. Of the 8 that completed or were terminated, 3 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 10 have an industry lead sponsor. The 6 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 4 studies filed under Endometriosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing relugolix in Endometriosis, 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 evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).
This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible participants who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled parent studies, MVT-601-3101 (SPIRIT 1 - NCT03204318) or MVT-601-3102 (SPIRIT 2 - NCT03204331). All participants will receive relugolix 40 mg orally once daily co-administered with low-dose E2 (1.0 mg) and NETA (0.5 mg) for 80 weeks.
Approximately 800 women with endometriosis-associated pain will be enrolled, after having completed a 24-week treatment period in one of the parent studies. The objectives of the study are to evaluate long-term efficacy and safety through up to 104 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose E2/NETA.
Baseline procedures for this extension study will be performed on the same day as the Week 24 Visit of the parent study. This visit, referred to as the "Week 24/Baseline Visit, will be defined as the date of completion of the last Week 24 procedure in the parent study. Participants will have received their last dose of study drug in the parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this extension study in the clinic after the participant is determined to be eligible for this extension study and has provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3103 will define enrollment into this study. Study participants will then take the open-label study treatment orally, once daily for 80 weeks.
Key Inclusion Criteria:
Key Exclusion Criteria:
Has any to treatment with low-dose E2 and NETA, including:
Had any of the following clinical laboratory abnormalities at the parent study Week 20 visit or, if available, any subsequent visit in one of the parent studies (MVT-601-3101 or MVT-601-3102):
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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 80 weeks.
Drug: Relugolix · Drug: Estradiol/norethindrone acetate
Relugolix 40-mg tablet administered orally once daily
Also known as: TAK-385, MVT-601
Drug pages: Estradiol · Norethindrone Acetate
Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
Also known as: E2/NETA, low-dose hormonal add-back
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 52 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Time frame: Week 52
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 52 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Time frame: Week 52
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 104 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Time frame: Week 104
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 104 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Time frame: Week 104
Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52
Assessed using the pain domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. The least squares (LS) mean was presented by pivotal study treatment group and by visit.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104
Assessed using the pain domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. The least squares (LS) mean was presented by pivotal study treatment group and by visit.
Time frame: Week 104
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 52
Assessed using the Pain Domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain.
Time frame: Week 52
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 104
Assessed using the Pain Domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain.
Time frame: Week 104
Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 104
Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 52
The PGIC for dysmenorrhea is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain during their menstrual cycle. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 104
Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 52
Assessed using an NRS score (11-point scale) for overall pain recorded daily in an electronic diary. Participants rated their overall pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 104
Assessed using an NRS score (11-point scale) for overall pain recorded daily in an electronic diary. Participants rated their overall pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 104
Percentage Of Participants Not Using Opioids For Endometriosis-associated Pain At Week 104
Assessed based on usage of study-specified opioids for endometriosis-associated pain recorded daily in an electronic diary. Participants received protocol-specified opioids for treatment of endometriosis-associated pain as needed for pain but not prophylactically.
Time frame: Week 104
Percentage Of Participants Not Using Analgesics For Endometriosis-associated Pain At Week 104
Assessed based on usage of study-specified analgesics for endometriosis-associated pain recorded daily in an electronic diary. Participants received protocol-specified analgesics for treatment of endometriosis-associated pain as needed for pain but not prophylactically.
Time frame: Week 104
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 52
The PGIC for NMPP is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain when they are not menstruating. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants were to report whether they had vaginal sexual intercourse and rated their level of pelvic pain during intercourse on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants were to report whether they had vaginal sexual intercourse and rated their level of pelvic pain during intercourse on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 104
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 52
The PGIC for dyspareunia is a 1-item questionnaire designed to assess participant's impression of change in the severity of their pain during sexual intercourse. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary. Participants were to report their pain during intercourse daily using the following response options: Severe (avoids intercourse because of pain), Moderate (intercourse painful to the point of causing interruption), Mild (tolerated pain), No pain (no pain during intercourse), or No intercourse (no intercourse for other reasons). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 104
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary. Participants were to report their pain during intercourse daily using the following response options: Severe (avoids intercourse because of pain), Moderate (intercourse painful to the point of causing interruption), Mild (tolerated pain), No pain (no pain during intercourse), or No intercourse (no intercourse for other reasons). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 104
Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 52
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 104
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 104
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4).
Time frame: Week 52
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4).
Time frame: Week 104
Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 52
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 104
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 104
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4).
Time frame: Week 52
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4).
Time frame: Week 104
Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52
Assessed using the following non-pain domains of the EHP-30 questionnaire: Control and Powerlessness (questions 12 through 17), Emotional Well-Being (questions 18 through 23), Social Support (questions 24 through 27), and Self-Image (questions 28 through 30). The score for each domain ranged from 0 to 100. Higher scores represent a greater impact of endometriosis. The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104
Assessed using the following non-pain domains of the EHP-30 questionnaire: Control and Powerlessness (questions 12 through 17), Emotional Well-Being (questions 18 through 23), Social Support (questions 24 through 27), and Self-Image (questions 28 through 30). The score for each domain ranged from 0 to 100. Higher scores represent a greater impact of endometriosis. The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 104
Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 52
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary. Participants were to report their pain as related to functional impairment daily in an electronic diary using the following response options: Severe (in bed all day, incapacitation), Moderate (in bed part of the day, some loss of work efficiency), Mild (some loss of work efficiency), No pain (no pain associated with menstruation during past 24 hours), or did not menstruate during the past 24 hours. Participants gave a possible score of 0 (no pain) to 4 (did not menstruate). The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 52
Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 104
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary. Participants were to report their pain as related to functional impairment daily in an electronic diary using the following response options: Severe (in bed all day, incapacitation), Moderate (in bed part of the day, some loss of work efficiency), Mild (some loss of work efficiency), No pain (no pain associated with menstruation during past 24 hours), or did not menstruate during the past 24 hours. Participants gave a possible score of 0 (no pain) to 4 (did not menstruate). The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 104
Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52
Assessed using the participant-modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary. Participants reported their pain daily in an electronic diary using the following response options: Severe (requires strong analgesics), Moderate (noticeable pelvic pain), Mild (occasional pelvic pain), or No pain (no pain during past 24 hours). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 52
Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104
Assessed using the participant-modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary. Participants reported their pain daily in an electronic diary using the following response options: Severe (requires strong analgesics), Moderate (noticeable pelvic pain), Mild (occasional pelvic pain), or No pain (no pain during past 24 hours). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Time frame: Week 104
Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52
Assessed by dual-energy X-ray absorptiometry (DXA) scan at lumbar spine, total hip, and femoral neck (same leg for each participant) at each designated time point. All participants who completed treatment or terminated from the study early were required to return for a 6-month post-treatment follow-up (PTFU) and a 12-month PTFU DXA scan (except if participant was beyond 14 months from last day on treatment). Participants were also to have clinical laboratory evaluations (vitamin D, thyroid stimulating hormone, parathyroid hormone, creatinine, calcium, and phosphorous) at the 6-month and 12-month PTFU only if the PTFU DXA scans showed a bone loss of ≥3% at the lumbar spine and/or total hip compared with the parent study baseline.
Time frame: Week 52
Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104
Assessed by dual-energy X-ray absorptiometry (DXA) scan at lumbar spine, total hip, and femoral neck (same leg for each participant) at each designated time point. All participants who completed treatment or terminated from the study early were required to return for a 6-month post-treatment follow-up (PTFU) and a 12-month PTFU DXA scan (except if participant was beyond 14 months from last day on treatment). Participants were also to have clinical laboratory evaluations (vitamin D, thyroid stimulating hormone, parathyroid hormone, creatinine, calcium, and phosphorous) at the 6-month and 12-month PTFU only if the PTFU DXA scans showed a bone loss of ≥3% at the lumbar spine and/or total hip compared with the parent study baseline.
Time frame: Week 104
Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52
Blood samples were collected from participants for estradiol measurements at each specified timepoints. Estradiol concentrations were measured using an immuno-enzymatic assay based on a commercially available kit.
Time frame: Week 52
Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104
Blood samples were collected from participants for estradiol measurements at each specified timepoints. Estradiol concentrations were measured using an immuno-enzymatic assay based on a commercially available kit.
Time frame: Week 104
All participants who completed their participation in one of the pivotal studies (MVT-601-3101 or MVT-601-3102) were eligible to enroll in this study.
| Milestone | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Started | 278 | 247 | 277 |
| Received at least 1 dose of study drug | 277 | 247 | 275 |
| Completed | 172 | 155 | 174 |
| Not completed | 106 | 92 | 103 |
| Withdrew: Adverse event | 19 | 23 | 24 |
| Withdrew: Protocol deviation | 0 | 2 | 0 |
| Withdrew: Lost to follow-up | 8 | 6 | 5 |
| Withdrew: Withdrawal by subject | 46 | 25 | 33 |
| Withdrew: Lack of efficacy | 4 | 5 | 7 |
| Withdrew: Pregnancy | 2 | 2 | 1 |
| Withdrew: Other | 27 | 29 | 32 |
| Withdrew: Participants who consented to week 52 and completed at week 52 | 0 | 0 | 1 |
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 52 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52 | 84.8 (80.06 to 88.85) | 82.2 (76.83 to 86.75) | 75.6 (70.12 to 80.59) |
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 52 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52 | 73.6 (68.04 to 78.74) | 70.4 (64.33 to 76.06) | 68.0 (62.13 to 73.47) |
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 104 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104 | 84.8 (80.06 to 88.85) | 83.0 (77.72 to 87.46) | 80.4 (75.17 to 84.89) |
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 104 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104 | 75.8 (70.33 to 80.74) | 71.7 (65.60 to 77.19) | 73.1 (67.44 to 78.24) |
Assessed using the pain domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. The least squares (LS) mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52 | -37.7 ± 1.34 | -36.1 ± 1.37 | -35.1 ± 1.32 |
Assessed using the pain domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. The least squares (LS) mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104 | -41.3 ± 1.33 | -38.9 ± 1.36 | -37.7 ± 1.29 |
Assessed using the Pain Domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 52 | 83.6 (78.22 to 88.14) | 81.2 (75.16 to 86.25) | 79.5 (73.66 to 84.51) |
Assessed using the Pain Domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 104 | 88.6 (82.80 to 93.01) | 85.4 (78.78 to 90.64) | 86.1 (80.06 to 90.90) |
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52 | -5.9 ± 0.15 | -5.7 ± 0.16 | -5.3 ± 0.15 |
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 104 | -5.9 ± 0.17 | -5.7 ± 0.18 | -5.6 ± 0.17 |
The PGIC for dysmenorrhea is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain during their menstrual cycle. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 52 | 89.1 (84.27 to 92.92) | 87.1 (81.71 to 91.42) | 83.0 (77.56 to 87.66) |
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 52 | -3.6 ± 0.15 | -3.4 ± 0.16 | -3.4 ± 0.15 |
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 104 | -4.0 ± 0.16 | -3.5 ± 0.17 | -3.8 ± 0.16 |
Assessed using an NRS score (11-point scale) for overall pain recorded daily in an electronic diary. Participants rated their overall pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 52 | -3.9 ± 0.15 | -3.6 ± 0.16 | -3.6 ± 0.15 |
Assessed using an NRS score (11-point scale) for overall pain recorded daily in an electronic diary. Participants rated their overall pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 104 | -4.2 ± 0.16 | -3.9 ± 0.17 | -4.0 ± 0.16 |
Assessed based on usage of study-specified opioids for endometriosis-associated pain recorded daily in an electronic diary. Participants received protocol-specified opioids for treatment of endometriosis-associated pain as needed for pain but not prophylactically.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Not Using Opioids For Endometriosis-associated Pain At Week 104 | 91.0 (87.0 to 94.1) | 88.3 (83.6 to 92.0) | 90.5 (86.5 to 93.7) |
Assessed based on usage of study-specified analgesics for endometriosis-associated pain recorded daily in an electronic diary. Participants received protocol-specified analgesics for treatment of endometriosis-associated pain as needed for pain but not prophylactically.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Not Using Analgesics For Endometriosis-associated Pain At Week 104 | 75.1 (69.6 to 80.1) | 76.5 (70.7 to 81.7) | 76.0 (70.5 to 80.9) |
The PGIC for NMPP is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain when they are not menstruating. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 52 | 85.5 (80.18 to 89.88) | 86.1 (80.59 to 90.59) | 79.1 (73.30 to 84.19) |
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants were to report whether they had vaginal sexual intercourse and rated their level of pelvic pain during intercourse on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 52 | -3.3 ± 0.18 | -3.0 ± 0.19 | -3.0 ± 0.18 |
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants were to report whether they had vaginal sexual intercourse and rated their level of pelvic pain during intercourse on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 104 | -3.5 ± 0.21 | -2.9 ± 0.22 | -3.4 ± 0.21 |
The PGIC for dyspareunia is a 1-item questionnaire designed to assess participant's impression of change in the severity of their pain during sexual intercourse. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 52 | 61.0 (54.00 to 67.59) | 61.9 (54.62 to 68.72) | 60.0 (53.03 to 66.68) |
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary. Participants were to report their pain during intercourse daily using the following response options: Severe (avoids intercourse because of pain), Moderate (intercourse painful to the point of causing interruption), Mild (tolerated pain), No pain (no pain during intercourse), or No intercourse (no intercourse for other reasons). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52 | -0.9 ± 0.06 | -0.9 ± 0.06 | -0.8 ± 0.06 |
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary. Participants were to report their pain during intercourse daily using the following response options: Severe (avoids intercourse because of pain), Moderate (intercourse painful to the point of causing interruption), Mild (tolerated pain), No pain (no pain during intercourse), or No intercourse (no intercourse for other reasons). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 104 | -1.0 ± 0.06 | -0.9 ± 0.07 | -1.0 ± 0.07 |
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 52 | -1.3 ± 0.06 | -1.2 ± 0.06 | -1.2 ± 0.06 |
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 104 | -1.4 ± 0.07 | -1.4 ± 0.07 | -1.3 ± 0.07 |
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4).
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Improvement (-1 to -4) | 81.5 | 69.9 | 72.6 |
| No Change (0) | 14.7 | 26.2 | 23.0 |
| Deterioration (+1 to +4) | 3.9 | 3.9 | 4.4 |
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4).
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Improvement (-1 to -4) | 85.5 | 82.2 | 80.4 |
| No Change (0) | 13.8 | 15.8 | 16.7 |
| Deterioration (+1 to +4) | 0.6 | 2.1 | 3.0 |
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 52 | -1.6 ± 0.06 | -1.6 ± 0.06 | -1.6 ± 0.06 |
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 104 | -1.9 ± 0.07 | -1.9 ± 0.07 | -1.8 ± 0.07 |
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4).
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Improvement (-1 to -4) | 88.9 | 86.9 | 86.1 |
| No Change (0) | 8.1 | 12.6 | 10.0 |
| Deterioration (+1 to +4) | 3.0 | 0.5 | 3.9 |
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4).
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Improvement (-1 to -4) | 92.7 | 92.0 | 91.2 |
| No Change (0) | 6.7 | 7.3 | 8.8 |
| Deterioration (+1 to +4) | 0.6 | 0.7 | 0 |
Assessed using the following non-pain domains of the EHP-30 questionnaire: Control and Powerlessness (questions 12 through 17), Emotional Well-Being (questions 18 through 23), Social Support (questions 24 through 27), and Self-Image (questions 28 through 30). The score for each domain ranged from 0 to 100. Higher scores represent a greater impact of endometriosis. The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Control and Powerlessness | -43.7 ± 1.61 | -40.1 ± 1.66 | -39.5 ± 1.59 |
| Emotional Well-being | -26.7 ± 1.51 | -24.4 ± 1.56 | -23.7 ± 1.49 |
| Social Support | -28.8 ± 1.69 | -28.9 ± 1.74 | -28.7 ± 1.67 |
| Self Image | -26.4 ± 1.70 | -23.1 ± 1.75 | -22.8 ± 1.68 |
Assessed using the following non-pain domains of the EHP-30 questionnaire: Control and Powerlessness (questions 12 through 17), Emotional Well-Being (questions 18 through 23), Social Support (questions 24 through 27), and Self-Image (questions 28 through 30). The score for each domain ranged from 0 to 100. Higher scores represent a greater impact of endometriosis. The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Control and Powerlessness | -47.5 ± 1.59 | -43.7 ± 1.63 | -41.9 ± 1.54 |
| Emotional Well-being | -30.7 ± 1.60 | -26.5 ± 1.65 | -25.6 ± 1.56 |
| Social Support | -33.2 ± 1.85 | -24.9 ± 1.90 | -29.7 ± 1.80 |
| Self Image | -29.5 ± 1.88 | -25.8 ± 1.94 | -25.2 ± 1.83 |
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary. Participants were to report their pain as related to functional impairment daily in an electronic diary using the following response options: Severe (in bed all day, incapacitation), Moderate (in bed part of the day, some loss of work efficiency), Mild (some loss of work efficiency), No pain (no pain associated with menstruation during past 24 hours), or did not menstruate during the past 24 hours. Participants gave a possible score of 0 (no pain) to 4 (did not menstruate). The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 52 | -1.3 ± 0.04 | -1.3 ± 0.04 | -1.2 ± 0.04 |
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary. Participants were to report their pain as related to functional impairment daily in an electronic diary using the following response options: Severe (in bed all day, incapacitation), Moderate (in bed part of the day, some loss of work efficiency), Mild (some loss of work efficiency), No pain (no pain associated with menstruation during past 24 hours), or did not menstruate during the past 24 hours. Participants gave a possible score of 0 (no pain) to 4 (did not menstruate). The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 104 | -1.3 ± 0.04 | -1.3 ± 0.05 | -1.2 ± 0.04 |
Assessed using the participant-modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary. Participants reported their pain daily in an electronic diary using the following response options: Severe (requires strong analgesics), Moderate (noticeable pelvic pain), Mild (occasional pelvic pain), or No pain (no pain during past 24 hours). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52 | -1.0 ± 0.04 | -1.0 ± 0.05 | -1.0 ± 0.04 |
Assessed using the participant-modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary. Participants reported their pain daily in an electronic diary using the following response options: Severe (requires strong analgesics), Moderate (noticeable pelvic pain), Mild (occasional pelvic pain), or No pain (no pain during past 24 hours). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104 | -1.2 ± 0.05 | -1.1 ± 0.05 | -1.1 ± 0.05 |
Assessed by dual-energy X-ray absorptiometry (DXA) scan at lumbar spine, total hip, and femoral neck (same leg for each participant) at each designated time point. All participants who completed treatment or terminated from the study early were required to return for a 6-month post-treatment follow-up (PTFU) and a 12-month PTFU DXA scan (except if participant was beyond 14 months from last day on treatment). Participants were also to have clinical laboratory evaluations (vitamin D, thyroid stimulating hormone, parathyroid hormone, creatinine, calcium, and phosphorous) at the 6-month and 12-month PTFU only if the PTFU DXA scans showed a bone loss of ≥3% at the lumbar spine and/or total hip compared with the parent study baseline.
| percent change | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Lumbar Spine (L1-L4) | -0.69 ± 0.241 | -1.09 ± 0.256 | -0.09 ± 0.244 |
| Femoral Neck | -0.21 ± 0.277 | -0.84 ± 0.294 | 0.06 ± 0.280 |
| Total Hip | -0.10 ± 0.207 | -0.52 ± 0.219 | 0.27 ± 0.210 |
Assessed by dual-energy X-ray absorptiometry (DXA) scan at lumbar spine, total hip, and femoral neck (same leg for each participant) at each designated time point. All participants who completed treatment or terminated from the study early were required to return for a 6-month post-treatment follow-up (PTFU) and a 12-month PTFU DXA scan (except if participant was beyond 14 months from last day on treatment). Participants were also to have clinical laboratory evaluations (vitamin D, thyroid stimulating hormone, parathyroid hormone, creatinine, calcium, and phosphorous) at the 6-month and 12-month PTFU only if the PTFU DXA scans showed a bone loss of ≥3% at the lumbar spine and/or total hip compared with the parent study baseline.
| percent change | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Lumbar Spine (L1-L4) | -0.45 ± 0.295 | -0.56 ± 0.310 | -0.09 ± 0.292 |
| Femoral Neck | 0.24 ± 0.325 | -0.44 ± 0.341 | -0.05 ± 0.324 |
| Total Hip | 0.82 ± 0.268 | 0.10 ± 0.281 | 0.69 ± 0.267 |
Blood samples were collected from participants for estradiol measurements at each specified timepoints. Estradiol concentrations were measured using an immuno-enzymatic assay based on a commercially available kit.
| pg/mL | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52 | -55.22 ± 99.636 | -77.76 ± 125.791 | -62.07 ± 90.031 |
Blood samples were collected from participants for estradiol measurements at each specified timepoints. Estradiol concentrations were measured using an immuno-enzymatic assay based on a commercially available kit.
| pg/mL | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104 | -51.72 ± 106.801 | -74.68 ± 138.840 | -64.39 ± 104.463 |
Collected over Week 24/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) | 0/277 (0%) | 7/277 (2.5%) | 173/277 (62.5%) |
| Relugolix Plus Delayed E2/NETA (Group B) | 0/247 (0%) | 19/247 (7.7%) | 106/247 (42.9%) |
| Placebo (Group C) | 0/275 (0%) | 18/275 (6.5%) | 151/275 (54.9%) |
| Event | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Suicidal ideationPsychiatric disorders | 0/277 | 3/247 | 1/275 |
| CholelithiasisHepatobiliary disorders | 0/277 | 2/247 | 1/275 |
| Corona virus infectionInfections and infestations | 0/277 | 2/247 | 1/275 |
| Tibia fractureInjury, poisoning and procedural complications | 0/277 | 2/247 | 0/275 |
| GoitreEndocrine disorders | 0/277 | 0/247 | 2/275 |
| EndometriosisReproductive system and breast disorders | 0/277 | 1/247 | 2/275 |
| Abdominal pain lowerGastrointestinal disorders | 0/277 | 1/247 | 0/275 |
| FatigueGeneral disorders | 0/277 | 1/247 | 0/275 |
| CholecystitisHepatobiliary disorders | 0/277 | 1/247 | 0/275 |
| Anaphylactic reactionImmune system disorders | 0/277 | 1/247 | 0/275 |
| Event | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| HeadacheNervous system disorders | 38/277 | 18/247 | 38/275 |
| Vulvovaginal mycotic infectionInfections and infestations | 28/277 | 12/247 | 15/275 |
| NasopharyngitisInfections and infestations | 24/277 | 14/247 | 22/275 |
| Vaginal infectionInfections and infestations | 22/277 | 18/247 | 17/275 |
| Corona virus infectionInfections and infestations | 13/277 | 18/247 | 21/275 |
| Urinary tract infectionInfections and infestations | 18/277 | 12/247 | 14/275 |
| Depressed moodPsychiatric disorders | 15/277 | 7/247 | 15/275 |
| Vulvovaginal drynessReproductive system and breast disorders | 15/277 | 7/247 | 9/275 |
Extension Study Population: all participants who enrolled into MVT-601-3103 study and received any amount of open-label study drug in MVT-601-3103 study. Three participants (1 in the relugolix plus E2/NETA group and 2 in the placebo group) were excluded due to Good Clinical Practice noncompliance at Site 3015 and no data is reported for these patients. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA.
| 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 | 277 | 247 | 275 | 799 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Female | 277 | 247 | 275 | 799 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 27 | 31 | 42 | 100 |
| Not Hispanic or Latino | 249 | 215 | 233 | 697 |
| Unknown or Not Reported | 1 | 1 | 0 | 2 |
| 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 | 1 | 1 | 0 | 2 |
| Asian | 0 | 1 | 0 | 1 |
| Black or African American | 17 | 7 | 13 | 37 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| White | 254 | 236 | 248 | 738 |
| Other | 1 | 0 | 8 | 9 |
| Multiple | 4 | 2 | 5 | 11 |
| Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| United States | 48 | 44 | 52 | 144 |
| Argentina | 10 | 12 | 12 | 34 |
| Australia | 2 | 4 | 5 | 11 |
| Belgium | 3 | 2 | 3 | 8 |
| Brazil | 13 | 13 | 15 | 41 |
| Bulgaria | 14 | 5 | 10 | 29 |
| Canada | 0 | 2 | 4 | 6 |
| Chile | 3 | 1 | 1 | 5 |
| Czechia | 12 | 8 | 8 | 28 |
| Finland | 2 | 2 | 1 | 5 |
| Georgia | 5 | 1 | 1 | 7 |
| Hungary | 7 | 10 | 7 | 24 |
| Italy | 7 | 8 | 2 | 17 |
| New Zealand | 2 | 2 | 4 | 8 |
| Poland | 105 | 86 | 106 | 297 |
| Portugal | 1 | 4 | 2 | 7 |
| Romania | 12 | 12 | 7 | 31 |
| South Africa | 8 | 10 | 14 | 32 |
| Spain | 0 | 1 | 1 | 2 |
| Ukraine | 23 | 20 | 20 | 63 |
| Time Since Surgical Diagnosis of Endometriosis(years) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Mean | 4.0 ± 3.52 | 4.7 ± 4.00 | 3.9 ± 3.24 | 4.2 ± 3.60 |
| Dysmenorrhea Numerical Rating Scale (NRS) Score at Baseline(score on a scale) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Mean | 7.1 ± 1.66 | 7.0 ± 1.65 | 7.2 ± 1.63 | 7.1 ± 1.65 |
| Nonmenstrual Pelvic Pain (NMPP) NRS Score at Baseline(score on a scale) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Mean | 5.7 ± 1.93 | 5.5 ± 1.98 | 5.7 ± 1.91 | 5.6 ± 1.94 |
3 further baseline measures are reported on the registry.
Showing the first 100 of 169 sites across 20 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Dec 2021, 42 months.
Results were first posted in Jul 2023, 1 year 7 months after primary completion.
Of 33 phase 3 interventional studies under Endometriosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 42. This study's 42 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Relugolix