NCT00185198CompletedPhase 3
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 363
- Primary Endpoint
- Lean body mass at 6 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1
Active Comparator
Intervention: Testogel (Testosterone, BAYV001915) (Drug)
Arm 2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Lean body mass at 6 months
Time Frame: baseline, month 6 and month 18
Secondary Outcomes
- 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)
Investigators
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