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NCT03049735 · ClinicalTrials.gov registry record · Phase 3
LIBERTY 1: Efficacy & Safety Study of Relugolix 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
- 388
- Enrollment target
NCT03049735: Completed Phase 3 study, sponsored by Myovant Sciences.
NCT03049735 is a Phase 3 study that has completed, run by Myovant Sciences. The registered enrollment target is 388 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03049735, a Phase 3 study, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 388 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
Primary Outcome
A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 24). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 24/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responder
Interventions
- DRUG Relugolix
- DRUG Estradiol/norethindrone acetate
- DRUG Relugolix placebo
- DRUG Estradiol/norethindrone acetate placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2017-04-26 |
| Est. Completion | 2020-08-24 |
| Phase | Phase 3 |
What the finished NCT03049735 record still lists
NCT03049735 is an interventional study that assigns participants to a tested intervention. The registered 388 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 (50% lower).
The record links to 0 conditions, and to 4 interventions - of which Relugolix is the first listed.
NCT03049735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03049735 about?
NCT03049735 is a clinical study titled "LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids". The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
What is the current status of trial NCT03049735?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 388 participants. The study started on 2017-04-26. Estimated completion is 2020-08-24.
What interventions are being tested in trial NCT03049735?
The interventions under investigation include: Relugolix (DRUG), Estradiol/norethindrone acetate (DRUG), Relugolix placebo (DRUG), Estradiol/norethindrone acetate placebo (DRUG).
Who is sponsoring clinical trial NCT03049735?
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 NCT03049735's enrollment target sits among peer trials
388 973rd of 2000 higher than 1,028 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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