Trials / Completed
CompletedNCT01104246
Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Watson Pharmaceuticals · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
Detailed description
Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Testerone Transdermal System | Transdermal testosterone applied daily for 4 weeks |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2010-09-01
- Completion
- 2010-09-01
- First posted
- 2010-04-15
- Last updated
- 2012-10-05
- Results posted
- 2011-02-23
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01104246. Inclusion in this directory is not an endorsement.