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NCT01984398 · ClinicalTrials.gov registry record · Phase 1
Comparison of Two Formulations of Androxal
A Phase 1 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01984398: Completed Phase 1 study, sponsored by Repros Therapeutics.
NCT01984398 is a Phase 1 study that has completed, run by Repros Therapeutics. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01984398, a Phase 1 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal
Primary Outcome
To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal
Interventions
- DRUG 12.5 mg Androxal Formulation A
- DRUG 12.5 mg Androxal Formulation B
- DRUG 25 mg Androxal Formulation A
- DRUG 25 mg Androxal Formulation B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-12-31 |
| Est. Completion | 2013-12-31 |
| Phase | Phase 1 |
What the finished NCT01984398 record still lists
NCT01984398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which 12.5 mg Androxal Formulation A is the first listed.
NCT01984398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01984398 about?
NCT01984398 is a clinical study titled "Comparison of Two Formulations of Androxal". To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal
What is the current status of trial NCT01984398?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2013-12-31. Estimated completion is 2013-12-31.
What interventions are being tested in trial NCT01984398?
The interventions under investigation include: 12.5 mg Androxal Formulation A (DRUG), 12.5 mg Androxal Formulation B (DRUG), 25 mg Androxal Formulation A (DRUG), 25 mg Androxal Formulation B (DRUG).
Who is sponsoring clinical trial NCT01984398?
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 NCT01984398's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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