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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 is a Phase 3 study that has completed, run by Myovant Sciences. The registered enrollment target is 229 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03751124
The ClinicalTrials.gov registry entry for NCT03751124 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Myovant Sciences, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Relugolix is the first listed.
NCT03751124 reports 0 study locations.
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.
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