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NCT03951077 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
A Phase 2 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT03951077: Completed Phase 2 study, sponsored by AbbVie.
NCT03951077 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03951077, a Phase 2 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
Study Summary
This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).
Primary Outcome
A participant was considered a menstrual cycle responder if she has at least 2 normal menstrual cycles during the final 4 months of the treatment period. In addition, a participant was considered a complete menstrual cycle responder if she has normal menstrual cycles beginning at or before Month 3 that are maintained through Month 6 during the treatment period.
Interventions
- DRUG Placebo
- DRUG Elagolix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2019-08-12 |
| Est. Completion | 2021-02-10 |
| Phase | Phase 2 |
What the finished NCT03951077 record still lists
NCT03951077 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03951077 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03951077 about?
NCT03951077 is a clinical study titled "Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome". This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).
What is the current status of trial NCT03951077?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2019-08-12. Estimated completion is 2021-02-10.
What interventions are being tested in trial NCT03951077?
The interventions under investigation include: Placebo (DRUG), Elagolix (DRUG).
Who is sponsoring clinical trial NCT03951077?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03951077's enrollment target sits among peer trials
118 618th of 2000 higher than 1,378 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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