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NCT01532414 · ClinicalTrials.gov registry record · Phase 3
Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism
A Phase 3 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 151
- Enrollment target
NCT01532414: Completed Phase 3 study, sponsored by Repros Therapeutics.
NCT01532414 is a Phase 3 study that has completed, run by Repros Therapeutics. The registered enrollment target is 151 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01532414, a Phase 3 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 151 participants
- Enrollment target
Study Summary
The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.
Primary Outcome
Proportion of pooled Androxal subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg will be calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing. If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the co-primary endpoint based on the Cavg for testosterone has been achieved. F
Interventions
- DRUG Placebo
- DRUG Androxal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT01532414 record still lists
NCT01532414 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01532414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01532414 about?
NCT01532414 is a clinical study titled "Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism". The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not hav...
What is the current status of trial NCT01532414?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 151 participants. The study started on 2012-08. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01532414?
The interventions under investigation include: Placebo (DRUG), Androxal (DRUG).
Who is sponsoring clinical trial NCT01532414?
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 NCT01532414's enrollment target sits among peer trials
151 1517th of 2000 higher than 482 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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