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NCT01962805 · ClinicalTrials.gov registry record · Phase 1
Comparison of Two Formulations of Proellex for Vaginal Administration
A Phase 1 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01962805: Completed Phase 1 study, sponsored by Repros Therapeutics.
NCT01962805 is a Phase 1 study that has completed, run by Repros Therapeutics. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01962805, a Phase 1 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations of Proellex for vaginal administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 8 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. Subjects will receive a single dose of Treatment A or daily dosing with Treatment B for 6 days. After a 7-day washout period subjects will receive the alternative treatment. On the day of treatment with Treatment A and on the first and last days of treatment with Treatment B subjects will remain in the clinic overnight and undergo 32-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 4, 8, 12, 16, 20, 24, 28 and 32 hours after administration of study drug. For Treatment B study drug will be administered in the clinic each day after a trough blood sample has been drawn.
Primary Outcome
To determine and compare the maximum measured plasma concentration over the final dosing interval(Cmax) of two formulations of 12 mg Proellex administered vaginally in female healthy volunteers once daily for up to 7 days.
Interventions
- DRUG Proellex Formulation A
- DRUG Proellex Formulation B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01962805 record still lists
NCT01962805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Proellex Formulation A is the first listed.
NCT01962805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01962805 about?
NCT01962805 is a clinical study titled "Comparison of Two Formulations of Proellex for Vaginal Administration". This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations of Proellex for vaginal administration. Each formulation will be designated as either Treatment A or Treatment B. A tot...
What is the current status of trial NCT01962805?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01962805?
The interventions under investigation include: Proellex Formulation A (DRUG), Proellex Formulation B (DRUG).
Who is sponsoring clinical trial NCT01962805?
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 NCT01962805's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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