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NCT01386567 · ClinicalTrials.gov registry record · Phase 2
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
A Phase 2 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT01386567: Completed Phase 2 study, sponsored by Repros Therapeutics.
NCT01386567 is a Phase 2 study that has completed, run by Repros Therapeutics. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01386567, a Phase 2 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.
Primary Outcome
Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim
Interventions
- DRUG Androxal (enclomiphene citrate)
- DRUG Testim (topical testosterone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT01386567 record still lists
NCT01386567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Androxal (enclomiphene citrate) is the first listed.
NCT01386567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01386567 about?
NCT01386567 is a clinical study titled "A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203". The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beg...
What is the current status of trial NCT01386567?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2011-07. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01386567?
The interventions under investigation include: Androxal (enclomiphene citrate) (DRUG), Testim (topical testosterone) (DRUG).
Who is sponsoring clinical trial NCT01386567?
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 NCT01386567's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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