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NCT01959685 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal
A Phase 1 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01959685: Completed Phase 1 study, sponsored by Repros Therapeutics.
NCT01959685 is a Phase 1 study that has completed, run by Repros Therapeutics. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01959685, a Phase 1 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.
Primary Outcome
Cmax of a single dose 125 mg of Androxal
Interventions
- DRUG Placebo
- DRUG Androxal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-10 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01959685 record still lists
NCT01959685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01959685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01959685 about?
NCT01959685 is a clinical study titled "A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal". To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.
What is the current status of trial NCT01959685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2013-10. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01959685?
The interventions under investigation include: Placebo (DRUG), Androxal (DRUG).
Who is sponsoring clinical trial NCT01959685?
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 NCT01959685's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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