Trials / Completed
CompletedNCT00220298
Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism
Open One-arm Study to Investigate Safety and Efficacy of Intramuscular Injections of 1000 mg Testosterone Undecanoate (TU) in Hypogonadal Men at Variable Intervals During a 136-week to 192-week Treatment Including Pharmacokinetics
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Testosterone undecanoate (TU) - NebidoTM | Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals |
Timeline
- Start date
- 2003-02-01
- Primary completion
- 2007-10-01
- Completion
- 2007-10-01
- First posted
- 2005-09-22
- Last updated
- 2014-12-30
Locations
14 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00220298. Inclusion in this directory is not an endorsement.