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NCT00741273 · ClinicalTrials.gov registry record · Phase 1
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
A Phase 1 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00741273: Completed Phase 1 study, sponsored by Repros Therapeutics.
NCT00741273 is a Phase 1 study that has completed, run by Repros Therapeutics. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00741273, a Phase 1 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
Primary Outcome
Cmax of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, assessed from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..
Interventions
- DRUG Proellex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-06 |
| Phase | Phase 1 |
What the finished NCT00741273 record still lists
NCT00741273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Proellex is the first listed.
NCT00741273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00741273 about?
NCT00741273 is a clinical study titled "Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults". This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
What is the current status of trial NCT00741273?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2008-10. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00741273?
The interventions under investigation include: Proellex (DRUG).
Who is sponsoring clinical trial NCT00741273?
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 NCT00741273's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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