Endometriosis
Conditions
Keywords
Endometriosis, Dysmenorrhea, Pain, Dyspareunia, Pelvic Pain
Brief summary
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).
Detailed description
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.
Interventions
DRUGRelugolix
Relugolix 40-mg tablet administered orally once daily
Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
Sponsors
Myovant Sciences GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label extension
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Completed 24 weeks of study drug treatment and study participation in either parent study, MVT-601-3101 or MVT-601-3102. 2. Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the participant does not desire such treatment during this time frame. 3. Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these. Key
Exclusion criteria
1. Has had a surgical procedure for treatment for endometriosis at any time during the parent study (MVT-601-3101 or MVT-601-3102). 2. Has any chronic pain or frequently recurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for ≥ 7 days per month. 3. Has a Z-score \< -2.0 or has a ≥ 7% decrease in bone mineral density from the parent study Baseline at lumbar spine, total hip, or femoral neck based on the parent study Week 24 DXA assessment of bone mineral density. 4. Has any contraindication to treatment with low-dose E2 and NETA, including: 1. Known, suspected, or history of breast cancer; 2. Known or suspected estrogen-dependent neoplasia; 3. Active deep vein thrombosis or pulmonary embolism, or history of these conditions prior to the Week 24/Baseline visit; 4. History of or active arterial thromboembolic disease, including stroke and myocardial infarction; 5. Known anaphylactic reaction or angioedema or hypersensitivity to E2 or NETA; 6. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilia disorders, including Factor V Leiden; 7. Migraine with aura; 8. History of porphyria. 5. 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): 1. Alanine aminotransferase or aspartate aminotransferase \> 2.0 times the upper limit of normal (ULN); or 2. Bilirubin (total bilirubin) \> 1.5 x ULN (or \> 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52 | 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. |
| Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52 | 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. |
| Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104 | 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. |
| Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 104 | 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. |
| Percentage Of Participants Who Are Better Or Much Better On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 104 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 104 | 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. |
| Percentage Of Participants Not Using Opioids For Endometriosis-associated Pain At Week 104 | 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. |
| Percentage Of Participants Not Using Analgesics For Endometriosis-associated Pain At Week 104 | 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. |
| Percentage Of Participants Who Are Better Or Much Better On The PGIC For NMPP At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 104 | 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. |
| Percentage Of Participants Who Are Better Or Much Better On The PGIC For Dyspareunia At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 104 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 104 | 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. |
| Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 | 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). |
| Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 | 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). |
| Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 104 | 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. |
| Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 | 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). |
| Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 | 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). |
| Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 104 | 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. |
| Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52 | 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. |
| Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104 | 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. |
| Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | 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. |
| Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52 | 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. |
| Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104 | 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. |
| Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52 | 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. |
| Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104 | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Finland, Georgia, Hungary, Italy, New Zealand, Poland, Portugal, Romania, South Africa, Spain, Ukraine, United States
Participant flow
Recruitment details
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.
Pre-assignment details
The study results were presented by pivotal study treatment but all the participants only received relugolix plus Estradiol (E2)/Norethindrone Acetate (NETA).
Participants by arm
| Arm | Count |
|---|---|
| Relugolix Plus E2/NETA (Group A) Relugolix 40 mg once daily co-administered with E2 (1 mg) and NETA (0.5 mg) for 24 weeks in the pivotal study followed by Relugolix 40 mg once daily co-administered with E2/NETA for 80 weeks in this extension study. | 277 |
| Relugolix Plus Delayed E2/NETA (Group B) Relugolix 40 mg monotherapy (once daily) for 12 weeks, followed by oral relugolix 40 mg once daily co-administered with E2 (1mg) and NETA (0.5 mg) for 12 weeks in the pivotal study and Relugolix 40 mg once daily co-administered with E2/NETA for 80 weeks in this extension study. | 247 |
| Placebo (Group C) Relugolix placebo co-administered with E2/NETA placebo for up to 24 weeks in the pivotal study followed by Relugolix 40 mg once daily co-administered with E2/NETA for 80 weeks in this extension study. | 275 |
| Total | 799 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 19 | 23 | 24 |
| Overall Study | Lack of Efficacy | 4 | 5 | 7 |
| Overall Study | Lost to Follow-up | 8 | 6 | 5 |
| Overall Study | Other | 27 | 29 | 32 |
| Overall Study | Participants Who Consented to Week 52 and Completed at Week 52 | 0 | 0 | 1 |
| Overall Study | Pregnancy | 2 | 2 | 1 |
| Overall Study | Protocol Deviation | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 46 | 25 | 33 |
Baseline characteristics
| Characteristic | Total | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 799 Participants | 277 Participants | 247 Participants | 275 Participants |
| BMD Femoral Neck | 0.92 g/cm^2 STANDARD_DEVIATION 0.149 | 0.93 g/cm^2 STANDARD_DEVIATION 0.157 | 0.92 g/cm^2 STANDARD_DEVIATION 0.136 | 0.93 g/cm^2 STANDARD_DEVIATION 0.151 |
| BMD Total Hip | 0.97 g/cm^2 STANDARD_DEVIATION 0.126 | 0.98 g/cm^2 STANDARD_DEVIATION 0.133 | 0.97 g/cm^2 STANDARD_DEVIATION 0.12 | 0.98 g/cm^2 STANDARD_DEVIATION 0.123 |
| Bone Mineral Density (BMD) Lumbar Spine L1-L4 | 1.14 g/cm^2 STANDARD_DEVIATION 0.153 | 1.14 g/cm^2 STANDARD_DEVIATION 0.163 | 1.14 g/cm^2 STANDARD_DEVIATION 0.144 | 1.14 g/cm^2 STANDARD_DEVIATION 0.149 |
| Dysmenorrhea Numerical Rating Scale (NRS) Score at Baseline | 7.1 score on a scale STANDARD_DEVIATION 1.65 | 7.1 score on a scale STANDARD_DEVIATION 1.66 | 7.0 score on a scale STANDARD_DEVIATION 1.65 | 7.2 score on a scale STANDARD_DEVIATION 1.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 100 Participants | 27 Participants | 31 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 697 Participants | 249 Participants | 215 Participants | 233 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Nonmenstrual Pelvic Pain (NMPP) NRS Score at Baseline | 5.6 score on a scale STANDARD_DEVIATION 1.94 | 5.7 score on a scale STANDARD_DEVIATION 1.93 | 5.5 score on a scale STANDARD_DEVIATION 1.98 | 5.7 score on a scale STANDARD_DEVIATION 1.91 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 37 Participants | 17 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized Multiple | 11 Participants | 4 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 1 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 738 Participants | 254 Participants | 236 Participants | 248 Participants |
| Region of Enrollment Argentina | 34 participants | 10 participants | 12 participants | 12 participants |
| Region of Enrollment Australia | 11 participants | 2 participants | 4 participants | 5 participants |
| Region of Enrollment Belgium | 8 participants | 3 participants | 2 participants | 3 participants |
| Region of Enrollment Brazil | 41 participants | 13 participants | 13 participants | 15 participants |
| Region of Enrollment Bulgaria | 29 participants | 14 participants | 5 participants | 10 participants |
| Region of Enrollment Canada | 6 participants | 0 participants | 2 participants | 4 participants |
| Region of Enrollment Chile | 5 participants | 3 participants | 1 participants | 1 participants |
| Region of Enrollment Czechia | 28 participants | 12 participants | 8 participants | 8 participants |
| Region of Enrollment Finland | 5 participants | 2 participants | 2 participants | 1 participants |
| Region of Enrollment Georgia | 7 participants | 5 participants | 1 participants | 1 participants |
| Region of Enrollment Hungary | 24 participants | 7 participants | 10 participants | 7 participants |
| Region of Enrollment Italy | 17 participants | 7 participants | 8 participants | 2 participants |
| Region of Enrollment New Zealand | 8 participants | 2 participants | 2 participants | 4 participants |
| Region of Enrollment Poland | 297 participants | 105 participants | 86 participants | 106 participants |
| Region of Enrollment Portugal | 7 participants | 1 participants | 4 participants | 2 participants |
| Region of Enrollment Romania | 31 participants | 12 participants | 12 participants | 7 participants |
| Region of Enrollment South Africa | 32 participants | 8 participants | 10 participants | 14 participants |
| Region of Enrollment Spain | 2 participants | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Ukraine | 63 participants | 23 participants | 20 participants | 20 participants |
| Region of Enrollment United States | 144 participants | 48 participants | 44 participants | 52 participants |
| Sex: Female, Male Female | 799 Participants | 277 Participants | 247 Participants | 275 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Time Since Surgical Diagnosis of Endometriosis | 4.2 years STANDARD_DEVIATION 3.6 | 4.0 years STANDARD_DEVIATION 3.52 | 4.7 years STANDARD_DEVIATION 4 | 3.9 years STANDARD_DEVIATION 3.24 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 277 | 0 / 247 | 0 / 275 |
| other Total, other adverse events | 173 / 277 | 106 / 247 | 151 / 275 |
| serious Total, serious adverse events | 7 / 277 | 19 / 247 | 18 / 275 |
Outcome results
Primary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104 | 84.8 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104 | 83.0 percentage of participants |
| Placebo (Group C) | Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104 | 80.4 percentage of participants |
Primary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52 | 84.8 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52 | 82.2 percentage of participants |
| Placebo (Group C) | Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52 | 75.6 percentage of participants |
Primary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104 | 75.8 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104 | 71.7 percentage of participants |
| Placebo (Group C) | Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104 | 73.1 percentage of participants |
Primary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52 | 73.6 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52 | 70.4 percentage of participants |
| Placebo (Group C) | Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52 | 68.0 percentage of participants |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104 | -1.2 score on a scale | Standard Error 0.05 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104 | -1.1 score on a scale | Standard Error 0.05 |
| Placebo (Group C) | Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104 | -1.1 score on a scale | Standard Error 0.05 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52 | -1.0 score on a scale | Standard Error 0.04 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52 | -1.0 score on a scale | Standard Error 0.05 |
| Placebo (Group C) | Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52 | -1.0 score on a scale | Standard Error 0.04 |
Secondary
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
Population: Extension Safety Population: all enrolled participants who received any amount of open-label study drug in MVT-601-3103. Study results are reported by pivotal study treatment, but all participants only received relugolix Plus E2/NETA. The number of participants analyzed represents the proportion of the participants with values at that time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104 | -51.72 pg/mL | Standard Deviation 106.801 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104 | -74.68 pg/mL | Standard Deviation 138.84 |
| Placebo (Group C) | Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104 | -64.39 pg/mL | Standard Deviation 104.463 |
Secondary
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
Population: Extension Safety Population: all enrolled participants who received any amount of open-label study drug in MVT-601-3103. Study results are reported by pivotal study treatment, but all participants only received relugolix Plus E2/NETA. The number of participants analyzed represents the proportion of the participants with values at that time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52 | -55.22 pg/mL | Standard Deviation 99.636 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52 | -77.76 pg/mL | Standard Deviation 125.791 |
| Placebo (Group C) | Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52 | -62.07 pg/mL | Standard Deviation 90.031 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 104 | -1.3 score on a scale | Standard Error 0.04 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 104 | -1.3 score on a scale | Standard Error 0.05 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 104 | -1.2 score on a scale | Standard Error 0.04 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 52 | -1.3 score on a scale | Standard Error 0.04 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 52 | -1.3 score on a scale | Standard Error 0.04 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 52 | -1.2 score on a scale | Standard Error 0.04 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Social Support | -33.2 score on a scale | Standard Error 1.85 |
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Control and Powerlessness | -47.5 score on a scale | Standard Error 1.59 |
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Emotional Well-being | -30.7 score on a scale | Standard Error 1.6 |
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Self Image | -29.5 score on a scale | Standard Error 1.88 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Self Image | -25.8 score on a scale | Standard Error 1.94 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Emotional Well-being | -26.5 score on a scale | Standard Error 1.65 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Social Support | -24.9 score on a scale | Standard Error 1.9 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Control and Powerlessness | -43.7 score on a scale | Standard Error 1.63 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Control and Powerlessness | -41.9 score on a scale | Standard Error 1.54 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Social Support | -29.7 score on a scale | Standard Error 1.8 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Self Image | -25.2 score on a scale | Standard Error 1.83 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104 | Emotional Well-being | -25.6 score on a scale | Standard Error 1.56 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Control and Powerlessness | -43.7 score on a scale | Standard Error 1.61 |
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Emotional Well-being | -26.7 score on a scale | Standard Error 1.51 |
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Social Support | -28.8 score on a scale | Standard Error 1.69 |
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Self Image | -26.4 score on a scale | Standard Error 1.7 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Self Image | -23.1 score on a scale | Standard Error 1.75 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Control and Powerlessness | -40.1 score on a scale | Standard Error 1.66 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Social Support | -28.9 score on a scale | Standard Error 1.74 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Emotional Well-being | -24.4 score on a scale | Standard Error 1.56 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Self Image | -22.8 score on a scale | Standard Error 1.68 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Emotional Well-being | -23.7 score on a scale | Standard Error 1.49 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Social Support | -28.7 score on a scale | Standard Error 1.67 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52 | Control and Powerlessness | -39.5 score on a scale | Standard Error 1.59 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix pus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 104 | -1.9 score on a scale | Standard Error 0.07 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 104 | -1.9 score on a scale | Standard Error 0.07 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 104 | -1.8 score on a scale | Standard Error 0.07 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix pus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 52 | -1.6 score on a scale | Standard Error 0.06 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 52 | -1.6 score on a scale | Standard Error 0.06 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 52 | -1.6 score on a scale | Standard Error 0.06 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | 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 score on a scale | Standard Error 0.07 |
| Relugolix Plus Delayed E2/NETA (Group B) | 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 score on a scale | Standard Error 0.07 |
| 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 | -1.3 score on a scale | Standard Error 0.07 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | 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 score on a scale | Standard Error 0.06 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 52 | -1.2 score on a scale | Standard Error 0.06 |
| 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 | -1.2 score on a scale | Standard Error 0.06 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104 | -41.3 score on a scale | Standard Error 1.33 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104 | -38.9 score on a scale | Standard Error 1.36 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104 | -37.7 score on a scale | Standard Error 1.29 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52 | -37.7 score on a scale | Standard Error 1.34 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52 | -36.1 score on a scale | Standard Error 1.37 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52 | -35.1 score on a scale | Standard Error 1.32 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 104 | -5.9 score on a scale | Standard Error 0.17 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 104 | -5.7 score on a scale | Standard Error 0.18 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 104 | -5.6 score on a scale | Standard Error 0.17 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52 | -5.9 score on a scale | Standard Error 0.15 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52 | -5.7 score on a scale | Standard Error 0.16 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52 | -5.3 score on a scale | Standard Error 0.15 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 104 | -1.0 score on a scale | Standard Error 0.06 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 104 | -0.9 score on a scale | Standard Error 0.07 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 104 | -1.0 score on a scale | Standard Error 0.07 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52 | -0.9 score on a scale | Standard Error 0.06 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52 | -0.9 score on a scale | Standard Error 0.06 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52 | -0.8 score on a scale | Standard Error 0.06 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 104 | -3.5 score on a scale | Standard Error 0.21 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 104 | -2.9 score on a scale | Standard Error 0.22 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 104 | -3.4 score on a scale | Standard Error 0.21 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 52 | -3.3 score on a scale | Standard Error 0.18 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 52 | -3.0 score on a scale | Standard Error 0.19 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 52 | -3.0 score on a scale | Standard Error 0.18 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 104 | -4.0 score on a scale | Standard Error 0.16 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 104 | -3.5 score on a scale | Standard Error 0.17 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 104 | -3.8 score on a scale | Standard Error 0.16 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 52 | -3.6 score on a scale | Standard Error 0.15 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 52 | -3.4 score on a scale | Standard Error 0.16 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 52 | -3.4 score on a scale | Standard Error 0.15 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 104 | -4.2 score on a scale | Standard Error 0.16 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 104 | -3.9 score on a scale | Standard Error 0.17 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 104 | -4.0 score on a scale | Standard Error 0.16 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. TThe overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 52 | -3.9 score on a scale | Standard Error 0.15 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 52 | -3.6 score on a scale | Standard Error 0.16 |
| Placebo (Group C) | Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 52 | -3.6 score on a scale | Standard Error 0.15 |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants Not Using Analgesics For Endometriosis-associated Pain At Week 104 | 75.1 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants Not Using Analgesics For Endometriosis-associated Pain At Week 104 | 76.5 percentage of participants |
| Placebo (Group C) | Percentage Of Participants Not Using Analgesics For Endometriosis-associated Pain At Week 104 | 76.0 percentage of participants |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix Plus E2/NETA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants Not Using Opioids For Endometriosis-associated Pain At Week 104 | 91.0 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants Not Using Opioids For Endometriosis-associated Pain At Week 104 | 88.3 percentage of participants |
| Placebo (Group C) | Percentage Of Participants Not Using Opioids For Endometriosis-associated Pain At Week 104 | 90.5 percentage of participants |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix Plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants Who Are Better Or Much Better On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 52 | 89.1 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants Who Are Better Or Much Better On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 52 | 87.1 percentage of participants |
| 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 | 83.0 percentage of participants |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants Who Are Better Or Much Better On The PGIC For Dyspareunia At Week 52 | 61.0 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants Who Are Better Or Much Better On The PGIC For Dyspareunia At Week 52 | 61.9 percentage of participants |
| Placebo (Group C) | Percentage Of Participants Who Are Better Or Much Better On The PGIC For Dyspareunia At Week 52 | 60.0 percentage of participants |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants Who Are Better Or Much Better On The PGIC For NMPP At Week 52 | 85.5 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants Who Are Better Or Much Better On The PGIC For NMPP At Week 52 | 86.1 percentage of participants |
| Placebo (Group C) | Percentage Of Participants Who Are Better Or Much Better On The PGIC For NMPP At Week 52 | 79.1 percentage of participants |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | 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 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | 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 | 85.4 percentage of participants |
| 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 | 86.1 percentage of participants |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | 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 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | 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 | 81.2 percentage of participants |
| 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 | 79.5 percentage of participants |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 | Improvement (-1 to -4) | 92.7 percentage of participants |
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 | No Change (0) | 6.7 percentage of participants |
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 | Deterioration (+1 to +4) | 0.6 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 | Deterioration (+1 to +4) | 0.7 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 | No Change (0) | 7.3 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 | Improvement (-1 to -4) | 92.0 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 | Deterioration (+1 to +4) | 0 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 | No Change (0) | 8.8 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104 | Improvement (-1 to -4) | 91.2 percentage of participants |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 | Improvement (-1 to -4) | 88.9 percentage of participants |
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 | Deterioration (+1 to +4) | 3.0 percentage of participants |
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 | No Change (0) | 8.1 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 | Improvement (-1 to -4) | 86.9 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 | No Change (0) | 12.6 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 | Deterioration (+1 to +4) | 0.5 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 | Deterioration (+1 to +4) | 3.9 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 | No Change (0) | 10.0 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52 | Improvement (-1 to -4) | 86.1 percentage of participants |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 | No Change (0) | 13.8 percentage of participants |
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 | Improvement (-1 to -4) | 85.5 percentage of participants |
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 | Deterioration (+1 to +4) | 0.6 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 | Deterioration (+1 to +4) | 2.1 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 | Improvement (-1 to -4) | 82.2 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 | No Change (0) | 15.8 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 | No Change (0) | 16.7 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 | Deterioration (+1 to +4) | 3.0 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104 | Improvement (-1 to -4) | 80.4 percentage of participants |
Secondary
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
Population: 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. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 | No Change (0) | 14.7 percentage of participants |
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 | Improvement (-1 to -4) | 81.5 percentage of participants |
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 | Deterioration (+1 to +4) | 3.9 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 | No Change (0) | 26.2 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 | Improvement (-1 to -4) | 69.9 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 | Deterioration (+1 to +4) | 3.9 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 | Improvement (-1 to -4) | 72.6 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 | Deterioration (+1 to +4) | 4.4 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52 | No Change (0) | 23.0 percentage of participants |
Secondary
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
Population: Extension Safety Population: all enrolled participants who received any amount of open-label study drug in MVT-601-3103. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The overall number of participants analyzed represents the number of participants evaluable at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 | Femoral Neck | 0.24 percent change | Standard Error 0.325 |
| Relugolix Plus E2/NETA (Group A) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 | Lumbar Spine (L1-L4) | -0.45 percent change | Standard Error 0.295 |
| Relugolix Plus E2/NETA (Group A) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 | Total Hip | 0.82 percent change | Standard Error 0.268 |
| Relugolix Plus Delayed E2/NETA (Group B) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 | Femoral Neck | -0.44 percent change | Standard Error 0.341 |
| Relugolix Plus Delayed E2/NETA (Group B) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 | Lumbar Spine (L1-L4) | -0.56 percent change | Standard Error 0.31 |
| Relugolix Plus Delayed E2/NETA (Group B) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 | Total Hip | 0.10 percent change | Standard Error 0.281 |
| Placebo (Group C) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 | Lumbar Spine (L1-L4) | -0.09 percent change | Standard Error 0.292 |
| Placebo (Group C) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 | Total Hip | 0.69 percent change | Standard Error 0.267 |
| Placebo (Group C) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104 | Femoral Neck | -0.05 percent change | Standard Error 0.324 |
Secondary
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
Population: Extension Safety Population: all enrolled participants who received any amount of open-label study drug in MVT-601-3103. Study results are reported by pivotal study treatment, but all participants only received relugolix plus E2/NETA. The number analyzed represents the proportion of the overall number of participants analyzed with values at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Lumbar Spine (L1-L4) | -0.69 percent change | Standard Error 0.241 |
| Relugolix Plus E2/NETA (Group A) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Femoral Neck | -0.21 percent change | Standard Error 0.277 |
| Relugolix Plus E2/NETA (Group A) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Total Hip | -0.10 percent change | Standard Error 0.207 |
| Relugolix Plus Delayed E2/NETA (Group B) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Femoral Neck | -0.84 percent change | Standard Error 0.294 |
| Relugolix Plus Delayed E2/NETA (Group B) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Total Hip | -0.52 percent change | Standard Error 0.219 |
| Relugolix Plus Delayed E2/NETA (Group B) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Lumbar Spine (L1-L4) | -1.09 percent change | Standard Error 0.256 |
| Placebo (Group C) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Femoral Neck | 0.06 percent change | Standard Error 0.28 |
| Placebo (Group C) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Total Hip | 0.27 percent change | Standard Error 0.21 |
| Placebo (Group C) | Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Lumbar Spine (L1-L4) | -0.09 percent change | Standard Error 0.244 |