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NCT02811159 · ClinicalTrials.gov registry record · Phase 2
An Extension Study of 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.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02811159: Clinical Trial Phase 2 study, sponsored by Repros Therapeutics.
NCT02811159 is a Phase 2 study that was terminated before completion, run by Repros Therapeutics. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02811159, a Phase 2 study, was terminated before completion, sponsored by Repros Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 \[NCT02323646\] or ZPU-203 \[NCT02301897\] and meet eligibility criteria.
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 Telapristone acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-07-26 |
| Est. Completion | 2017-05-04 |
| Phase | Phase 2 |
Why NCT02811159 stopped before completion
NCT02811159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Telapristone acetate is the first listed.
NCT02811159 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02811159 about?
NCT02811159 is a clinical study titled "An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids". To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 \[NCT02323646\] or ZPU-203 \[NCT02301897\] and meet eligibility criteria.
What is the current status of trial NCT02811159?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2016-07-26. Estimated completion is 2017-05-04.
What interventions are being tested in trial NCT02811159?
The interventions under investigation include: Telapristone acetate (DRUG).
Who is sponsoring clinical trial NCT02811159?
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 NCT02811159's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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