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NCT03751124 · ClinicalTrials.gov registry record · Phase 3
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
A Phase 3 study, sponsored by Myovant Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 229
- Enrollment target
NCT03751124: Completed Phase 3 study, sponsored by Myovant Sciences.
NCT03751124 is a Phase 3 study that has completed, run by Myovant Sciences. The registered enrollment target is 229 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03751124, a Phase 3 study, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 229 participants
- Enrollment target
Study Summary
The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment, including a 24-week treatment period in a parent study (study MVT-601-3001 or MVT-601-3002) and a 28-week treatment period in the open-label extension study (MVT-601-3003), and who meet the definition of responder, defined as a patient who demonstrates a menstrual blood loss of \< 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.
Primary Outcome
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume \< 80 mL through Week 76 using the Kap
Interventions
- DRUG Relugolix
- DRUG Estradiol/norethindrone acetate
- DRUG Placebo for relugolix
- DRUG Placebo for E2/NETA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2021-10-20 |
| Phase | Phase 3 |
What the finished NCT03751124 record still lists
NCT03751124 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which Relugolix is the first listed.
NCT03751124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03751124 about?
NCT03751124 is a clinical study titled "Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids". The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment...
What is the current status of trial NCT03751124?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 229 participants. The study started on 2018-10-16. Estimated completion is 2021-10-20.
What interventions are being tested in trial NCT03751124?
The interventions under investigation include: Relugolix (DRUG), Estradiol/norethindrone acetate (DRUG), Placebo for relugolix (DRUG), Placebo for E2/NETA (DRUG).
Who is sponsoring clinical trial NCT03751124?
This trial is sponsored by Myovant Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03751124's enrollment target sits among peer trials
229 1309th of 2000 higher than 692 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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