NCT00185198

Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)

Multicenter, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone 50-100mg) to Evaluate Its Efficacy and Safety in Men Presenting With Typical Symptoms of Partial Androgen Deficiency of Aging Males (PADAM) Over a Period of 6 Months With 12 Months Open Label Follow-up

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Androgens (Deficiency)
• Male

Interventions

Type	Name	Description
DRUG	Testogel (Testosterone, BAYV001915)	50mg (5g gel sachet), 75mg (5g+2.5g sachet) or 100mg (2x5g sachet) per day applied to the skin of the shoulders, arms or abdomen for 18 months
DRUG	Placebo	5g gel sachet, 5g+2.5g sachet or 2x5g sachets per day applied to the skin of the shoulders, arms or abdomen for 6 months followed by 12 months treatment with testosterone 1% gel as described for arm 1

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-09-01
• Completion: 2007-10-01
• First posted: 2005-09-16
• Last updated: 2014-04-02

Locations

30 sites across 8 countries: Austria, Finland, Germany, Ireland, Italy, Spain, Sweden, United Kingdom