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NCT02141061 · ClinicalTrials.gov registry record · Phase 1
Comparison of Two Formulations of Proellex for Oral Administration
A Phase 1 study of Healthy, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02141061 is a Phase 1 study of Healthy that has completed, run by Repros Therapeutics. The registered enrollment target is 12 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02141061, a Phase 1 study of Healthy, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of a single dose each of two different formulations of Proellex for oral administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. On the day of each treatment subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after administration of study drug.
Conditions Studied
Interventions
- DRUG Telapristone Acetate, Proellex 12 mg Formulation A
- DRUG Telapristone Acetate, Proellex 12 mg Formulation B
Study Locations (1)
Texas
- - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-05 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02141061
The ClinicalTrials.gov registry entry for NCT02141061 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The listed sponsor is Repros Therapeutics, which has 50 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Telapristone Acetate, Proellex 12 mg Formulation A is the first listed.
NCT02141061 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02141061 about?
NCT02141061 is a clinical study titled "Comparison of Two Formulations of Proellex for Oral Administration". This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of a single dose each of two different formulations of Proellex for oral administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 12 subjec...
What is the current status of trial NCT02141061?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2014-05. Estimated completion is 2014-06.
What conditions does trial NCT02141061 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02141061?
The interventions under investigation include: Telapristone Acetate, Proellex 12 mg Formulation A (DRUG), Telapristone Acetate, Proellex 12 mg Formulation B (DRUG).
Who is sponsoring clinical trial NCT02141061?
This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02141061 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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