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NCT01728454 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis
A Phase 2 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT01728454: Completed Phase 2 study, sponsored by Repros Therapeutics.
NCT01728454 is a Phase 2 study that has completed, run by Repros Therapeutics. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01728454, a Phase 2 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine the safety and efficacy of two oral doses of telapristone acetate administered to premenopausal women with pelvic pain associated with endometriosis confirmed within the last seven years and using prescription analgesics for symptomatic pain.
Primary Outcome
The BBSS scale defined dysmenorrhea according to the loss of work efficiency and need for bed rest. The dysmenorrhea was graded on a scale from 0 to 3 where, 0 = None; 1 = Mild (some loss in work efficiency); 2 = Moderate (in bed part of the day, occasional loss of work efficiency); 3 = Severe (in bed one or more days, incapacitation), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endo
Interventions
- DRUG Placebo
- DRUG Telapristone acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-05-02 |
| Est. Completion | 2017-03-15 |
| Phase | Phase 2 |
What the finished NCT01728454 record still lists
NCT01728454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01728454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01728454 about?
NCT01728454 is a clinical study titled "Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis". The primary purpose of this study is to determine the safety and efficacy of two oral doses of telapristone acetate administered to premenopausal women with pelvic pain associated with endometriosis confirmed within the last seven years and using prescription analgesics for symptomatic pain.
What is the current status of trial NCT01728454?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2013-05-02. Estimated completion is 2017-03-15.
What interventions are being tested in trial NCT01728454?
The interventions under investigation include: Placebo (DRUG), Telapristone acetate (DRUG).
Who is sponsoring clinical trial NCT01728454?
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 NCT01728454's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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