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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
363
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
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
Unnamed facility
Vienna, Vienna, Austria
Unnamed facility
Graz, Austria
Lean body mass at 6 months
Time frame: baseline, month 6 and month 18
Change in total body mass, fat mass and bone density
Time frame: baseline, month 6 and month 18
Evaluation of symptoms by the aging males symptoms rating scale
Time frame: baseline, month 6 and month 18
Change in testosterone
Time frame: baseline, month 6 and month 18
Safety parameters
Time frame: baseline, month 6 and month 18
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Innsbruck, Austria
Unnamed facility
Salzburg, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Helsinki, Finland
Unnamed facility
Oulu, Finland
Unnamed facility
Tampere, Finland
Unnamed facility
Bonn, North Rhine-Westphalia, Germany
Unnamed facility
Dresden, Saxony, Germany
...and 20 more locations