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NCT01923857 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function
A Phase 1 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01923857: Completed Phase 1 study, sponsored by Repros Therapeutics.
NCT01923857 is a Phase 1 study that has completed, run by Repros Therapeutics. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01923857, a Phase 1 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
* To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function. * To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function.
Primary Outcome
Pharmacokinetic parameters calculated as a ratio in subjects with mild or moderate renal impairment to normal after a single dose of 25 mg Androxal.
Interventions
- DRUG Androxal 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01923857 record still lists
NCT01923857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Androxal 25 mg is the first listed.
NCT01923857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01923857 about?
NCT01923857 is a clinical study titled "Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function". * To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function. * To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects wit...
What is the current status of trial NCT01923857?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2013-08. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01923857?
The interventions under investigation include: Androxal 25 mg (DRUG).
Who is sponsoring clinical trial NCT01923857?
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 NCT01923857's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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