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

Bayer

Status and phase: Completed; Phase 3

Conditions: Male; Androgens (Deficiency)

Treatments: Drug: Testogel (Testosterone, BAYV001915); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185198

91297

2004-001545-15 (EudraCT Number)

307720 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 363 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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363 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Treatment:

Drug: Testogel (Testosterone, BAYV001915)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo