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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Male, Androgens (Deficiency)

Intervention / Treatment
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* Drug: Testogel (Testosterone, BAYV001915)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: Testogel (Testosterone, BAYV001915)<br>* 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<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass at 6 months |  | baseline, month 6 and month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total body mass, fat mass and bone density |  | baseline, month 6 and month 18 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial androgen deficiency of aging males (PADAM)