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NCT00620503 · ClinicalTrials.gov registry record · Phase 1
Proellex® Pharmacokinetic Bridging Study II
A Phase 1 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00620503: Completed Phase 1 study, sponsored by Repros Therapeutics.
NCT00620503 is a Phase 1 study that has completed, run by Repros Therapeutics. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00620503, a Phase 1 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.
Primary Outcome
Maximum observed concentration (Cmax) of a single dose of Proellex® (25 mg) Formulation A using two different formulations of the drug in healthy adult female subjects with or without fasting
Interventions
- DRUG Proellex 25 mg formulation A
- DRUG Proellex 25 mg formulation B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-02-29 |
| Est. Completion | 2008-04-30 |
| Phase | Phase 1 |
What the finished NCT00620503 record still lists
NCT00620503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Proellex 25 mg formulation A is the first listed.
NCT00620503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00620503 about?
NCT00620503 is a clinical study titled "Proellex® Pharmacokinetic Bridging Study II". An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.
What is the current status of trial NCT00620503?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2008-02-29. Estimated completion is 2008-04-30.
What interventions are being tested in trial NCT00620503?
The interventions under investigation include: Proellex 25 mg formulation A (DRUG), Proellex 25 mg formulation B (DRUG).
Who is sponsoring clinical trial NCT00620503?
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 NCT00620503's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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