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NCT01993225 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
A Phase 3 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
NCT01993225: Completed Phase 3 study, sponsored by Repros Therapeutics.
NCT01993225 is a Phase 3 study that has completed, run by Repros Therapeutics. The registered enrollment target is 120 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01993225, a Phase 3 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
Study Summary
This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
Primary Outcome
Comparison of the proportion of subjects whose 24-hour average testosterone levels are within the normal range \[300-1,040 ng/dL\] and whose sperm concentration is 15 million/mL or greater following 16 weeks of treatment with Androxal, placebo or AndroGel 1.62%.
Interventions
- DRUG Placebo Capsules
- DRUG Placebo Gel
- DRUG AndroGel 1.62%
- DRUG Androxal 12.5 mg/25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
What the finished NCT01993225 record still lists
NCT01993225 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (84% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo Capsules is the first listed.
NCT01993225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01993225 about?
NCT01993225 is a clinical study titled "A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%". This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
What is the current status of trial NCT01993225?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2014-01. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01993225?
The interventions under investigation include: Placebo Capsules (DRUG), Placebo Gel (DRUG), AndroGel 1.62% (DRUG), Androxal 12.5 mg/25 mg (DRUG).
Who is sponsoring clinical trial NCT01993225?
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 NCT01993225's enrollment target sits among peer trials
120 1619th of 2000 higher than 361 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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