Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Clarus Therapeutics. The registered enrollment target is 325 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01403116
The ClinicalTrials.gov registry entry for NCT01403116 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clarus Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oral testosterone undecanoate is the first listed.
NCT01403116 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.