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OpenTrials
Completed

NCT Number: NCT00185198

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

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.

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Key information

Conditions

Androgens (Deficiency) Male

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Vienna, State of Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testogel (Testosterone, BAYV001915)

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Lean body mass at 6 months

    Time frame: baseline, month 6 and month 18

Secondary outcomes

  1. Change in total body mass, fat mass and bone density

    Time frame: baseline, month 6 and month 18

  2. Evaluation of symptoms by the aging males symptoms rating scale

    Time frame: baseline, month 6 and month 18

  3. Change in testosterone

    Time frame: baseline, month 6 and month 18

  4. Safety parameters

    Time frame: baseline, month 6 and month 18

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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