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NCT01699178 · ClinicalTrials.gov registry record · Phase 3
Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
A Phase 3 study, sponsored by Clarus Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 182
- Enrollment target
NCT01699178: Completed Phase 3 study, sponsored by Clarus Therapeutics.
NCT01699178 is a Phase 3 study that has completed, run by Clarus Therapeutics. The registered enrollment target is 182 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01699178, a Phase 3 study, has completed, sponsored by Clarus Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 182 participants
- Enrollment target
Study Summary
The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.
Primary Outcome
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Interventions
- DRUG Oral testosterone undecanoate
- DRUG Transdermal testosterone gel (AndroGel)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01699178 record still lists
NCT01699178 is an interventional study that assigns participants to a tested intervention. The registered 182 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Oral testosterone undecanoate is the first listed.
NCT01699178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01699178 about?
NCT01699178 is a clinical study titled "Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men". The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.
What is the current status of trial NCT01699178?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 182 participants. The study started on 2012-08. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01699178?
The interventions under investigation include: Oral testosterone undecanoate (DRUG), Transdermal testosterone gel (AndroGel) (DRUG).
Who is sponsoring clinical trial NCT01699178?
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 NCT01699178's enrollment target sits among peer trials
182 1421st of 2000 higher than 579 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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