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NCT03412890 · ClinicalTrials.gov registry record · Phase 3
LIBERTY EXTENSION: Efficacy and Safety Extension 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
- 477
- Enrollment target
NCT03412890: Completed Phase 3 study, sponsored by Myovant Sciences.
NCT03412890 is a Phase 3 study that has completed, run by Myovant Sciences. The registered enrollment target is 477 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03412890, a Phase 3 study, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 477 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (MVT-601-3001 or MVT-601-3002).
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 52). 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 52/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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 477 participants |
| Start Date | 2017-10-19 |
| Est. Completion | 2021-01-13 |
| Phase | Phase 3 |
What the finished NCT03412890 record still lists
NCT03412890 is an interventional study that assigns participants to a tested intervention. The registered 477 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 (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Relugolix is the first listed.
NCT03412890 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03412890 about?
NCT03412890 is a clinical study titled "LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids". The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously comple...
What is the current status of trial NCT03412890?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 477 participants. The study started on 2017-10-19. Estimated completion is 2021-01-13.
What interventions are being tested in trial NCT03412890?
The interventions under investigation include: Relugolix (DRUG), Estradiol/norethindrone acetate (DRUG).
Who is sponsoring clinical trial NCT03412890?
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 NCT03412890's enrollment target sits among peer trials
477 807th of 2000 higher than 1,193 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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