Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03654274) enrolled 802 participants across three groups: one group received relugolix combined with oestradiol and norethindrone acetate (E2/NETA) from the start (Group A, 278 people); a second group received relugolix with E2/NETA added in after a delay (Group B, 247 people); and a third group received a placebo, meaning a dummy pill with no active ingredient (Group C, 277 people). The trial measured two types of pelvic pain common in endometriosis — period pain (called dysmenorrhea) and non-menstrual pelvic pain (NMPP) — using a self-reported pain scale from 0 to 10. Participants were tracked over roughly two years (up to Week 104). The reported data shows that, at Week 52, the percentage of participants whose period pain score dropped by a meaningful amount (at least 2.8 points on the scale) without needing more pain relief was 84.8% in Group A, 82.2% in Group B, and 75.6% in Group C. For non-menstrual pelvic pain at Week 52 (requiring a drop of at least 2.1 points), the reported figures were 73.6% in Group A, 70.4% in Group B, and 68.0% in Group C. At Week 104, the reported responder rates for period pain were 84.8% (Group A), 83.0% (Group B), and 80.4% (Group C); and for non-menstrual pelvic pain, 75.8% (Group A), 71.7% (Group B), and 73.1% (Group C). The reported data also shows changes in a quality-of-life pain questionnaire (scored 0–100, where higher scores mean greater impact of pain on daily life). At Week 52, average scores decreased by 37.7 points in Group A, 36.1 points in Group B, and 35.1 points in Group C. By Week 104, the reported decreases were 41.3 points (Group A), 38.9 points (Group B), and 37.7 points (Group C), indicating that reported pain impact on daily activities went down across all groups over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38906210) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Endometriosis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have already completed 24 weeks of treatment and participation in one of the two related earlier studies (MVT-601-3101 or MVT-601-3102).
- You are not expected to have any surgery for endometriosis (such as ablation, shaving, or excision) during this study, and you do not wish to have such surgery during this time.
- You have agreed to use only the pain medications specified by the study, and you are able to tolerate those medications.
Who may not be able to join:
- You had surgery to treat your endometriosis at any point during the earlier related study.
- You have another ongoing or frequent pain condition (other than endometriosis) that requires opioid painkillers or any pain medication for 7 or more days per month.
- Your bone density scan at week 24 of the earlier study showed significantly reduced bone strength — either a Z-score below -2.0 or a drop of 7% or more in bone density in the lower spine, hip, or upper thigh bone (confirm with trial site).
- You have any medical reason why you cannot take low-dose estrogen (E2) or a hormone called NETA, including: a personal history or suspicion of breast cancer; certain hormone-sensitive tumours; current or past blood clots in the legs or lungs; history of stroke or heart attack; a known severe allergic reaction to E2 or NETA; certain inherited blood-clotting disorders (such as Factor V Leiden); migraines with visual disturbances (aura); or a condition called porphyria.
- Your blood tests during the earlier study showed that your liver was not functioning normally — specifically, if certain liver-related measurements were significantly above the normal range (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Myovant Medical Monitor, Myovant Sciences
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52; Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52; Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104; Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.