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NCT01403116 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
A Phase 3 study, sponsored by Clarus Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 325
- Enrollment target
NCT01403116: Completed Phase 3 study, sponsored by Clarus Therapeutics.
NCT01403116 is a Phase 3 study that has completed, run by Clarus Therapeutics. The registered enrollment target is 325 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01403116, a Phase 3 study, has completed, sponsored by Clarus Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 325 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
Primary Outcome
The percentages of treated subjects that had 24-hour serum testosterone (T) average concentrations (Cavg) between 300 and 1000 ng/dL
Interventions
- DRUG Oral testosterone undecanoate
- DRUG topical testosterone gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
What the finished NCT01403116 record still lists
NCT01403116 is an interventional study that assigns participants to a tested intervention. The registered 325 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 (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Oral testosterone undecanoate is the first listed.
NCT01403116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01403116 about?
NCT01403116 is a clinical study titled "Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men". The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
What is the current status of trial NCT01403116?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 325 participants. The study started on 2011-07. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01403116?
The interventions under investigation include: Oral testosterone undecanoate (DRUG), topical testosterone gel (DRUG).
Who is sponsoring clinical trial NCT01403116?
This trial is sponsored by Clarus Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01403116's enrollment target sits among peer trials
325 1076th of 2000 higher than 922 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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