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NCT01631903 · ClinicalTrials.gov registry record · Phase 2
Extension of Study ZPV-200
A Phase 2 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT01631903: Completed Phase 2 study, sponsored by Repros Therapeutics.
NCT01631903 is a Phase 2 study that has completed, run by Repros Therapeutics. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01631903, a Phase 2 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.
Primary Outcome
The primary efficacy endpoint will be bleeding assessed using the change in PBAC scores from the 4 weeks prior to Visit 2 to the 4 weeks prior to Visit 10
Interventions
- DRUG telepristone acetate 12 mg
- DRUG telepristone acetate 3 mg
- DRUG telepristone acetate 6 mg
- DRUG telepristone acetate 24 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT01631903 record still lists
NCT01631903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 4 interventions - of which telepristone acetate 12 mg is the first listed.
NCT01631903 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01631903 about?
NCT01631903 is a clinical study titled "Extension of Study ZPV-200". The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.
What is the current status of trial NCT01631903?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2012-09. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01631903?
The interventions under investigation include: telepristone acetate 12 mg (DRUG), telepristone acetate 3 mg (DRUG), telepristone acetate 6 mg (DRUG), telepristone acetate 24 mg (DRUG).
Who is sponsoring clinical trial NCT01631903?
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 NCT01631903's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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