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NCT02301897 · ClinicalTrials.gov registry record · Phase 2
A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
A Phase 2 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT02301897: Completed Phase 2 study, sponsored by Repros Therapeutics.
NCT02301897 is a Phase 2 study that has completed, run by Repros Therapeutics. The registered enrollment target is 43 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
NCT02301897, a Phase 2 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the safety and efficacy of two oral 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 no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.
Interventions
- DRUG Placebo
- DRUG Telapristone Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-03-16 |
| Est. Completion | 2017-06-02 |
| Phase | Phase 2 |
What the finished NCT02301897 record still lists
NCT02301897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 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.
NCT02301897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02301897 about?
NCT02301897 is a clinical study titled "A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids". The primary objective of this study is to determine the safety and efficacy of two oral 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 NCT02301897?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2015-03-16. Estimated completion is 2017-06-02.
What interventions are being tested in trial NCT02301897?
The interventions under investigation include: Placebo (DRUG), Telapristone Acetate (DRUG).
Who is sponsoring clinical trial NCT02301897?
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 NCT02301897's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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