Trials / Completed
CompletedNCT01765179
Safety and Efficacy Trial of Testosterone Undecanoate
Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 144 (actual)
- Sponsor
- Clarus Therapeutics, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oral testosterone undecanoate | Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments. |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2013-07-01
- Completion
- 2013-07-01
- First posted
- 2013-01-10
- Last updated
- 2017-12-12
- Results posted
- 2017-09-21
Locations
27 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01765179. Inclusion in this directory is not an endorsement.