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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 is a Phase 1 study that has completed, run by Repros Therapeutics. The registered enrollment target is 8 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01962805
The ClinicalTrials.gov registry entry for NCT01962805 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Repros Therapeutics, which has 50 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Proellex Formulation A is the first listed.
NCT01962805 reports 0 study locations.
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.
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