Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)
Phase 3
Completed
- Conditions
- Androgens (Deficiency)Male
- Interventions
- Drug: Testogel (Testosterone, BAYV001915)Drug: Placebo
- Registration Number
- NCT00185198
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to investigate the effect of a testosterone replacement therapy called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and other symptoms of PADAM and safety will be studied.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 363
Inclusion Criteria
- Symptomatic hypogonadism
- Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study
Exclusion Criteria
- Patients with any contraindication for testosterone use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Testogel (Testosterone, BAYV001915) - Arm 2 Placebo -
- Primary Outcome Measures
Name Time Method Lean body mass at 6 months baseline, month 6 and month 18
- Secondary Outcome Measures
Name Time Method Evaluation of symptoms by the aging males symptoms rating scale baseline, month 6 and month 18 Change in testosterone baseline, month 6 and month 18 Safety parameters baseline, month 6 and month 18 Change in total body mass, fat mass and bone density baseline, month 6 and month 18