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NCT02323646 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
A Phase 2 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT02323646: Completed Phase 2 study, sponsored by Repros Therapeutics.
NCT02323646 is a Phase 2 study that has completed, run by Repros Therapeutics. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02323646, a Phase 2 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.
Primary Outcome
Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score \>1. Participants were provided with a daily diary and Pictorial Blood Loss Assessment Chart (PBAC) to record information about the menstrual blood loss (MBL). Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.
Interventions
- DRUG Placebo
- DRUG Telapristone Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-02-12 |
| Est. Completion | 2017-04-06 |
| Phase | Phase 2 |
What the finished NCT02323646 record still lists
NCT02323646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02323646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02323646 about?
NCT02323646 is a clinical study titled "Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids". The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.
What is the current status of trial NCT02323646?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2015-02-12. Estimated completion is 2017-04-06.
What interventions are being tested in trial NCT02323646?
The interventions under investigation include: Placebo (DRUG), Telapristone Acetate (DRUG).
Who is sponsoring clinical trial NCT02323646?
This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02323646's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 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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