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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00185198
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 2, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Androgens (Deficiency) Male Drug: Testogel (Testosterone, BAYV001915) Drug: Placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Arm 1 Drug: Testogel (Testosterone, BAYV001915)
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 Comparator: Arm 2 Drug: Placebo
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 Outcome Measures :
  1. Lean body mass at 6 months [ Time Frame: baseline, month 6 and month 18 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00185198

Graz, Austria, 8036
Innsbruck, Austria, 6020
Salzburg, Austria, 5020
Wien, Austria, 1021
Wien, Austria, 1090
Helsinki, Finland, 00260
Oulu, Finland, 90100
Tampere, Finland, 33521
Bonn, Nordrhein-Westfalen, Germany, 53105
Halle, Sachsen-Anhalt, Germany, 06112
Dresden, Sachsen, Germany, 01067
Leipzig, Sachsen, Germany, 04103
Magdeburg, Germany, 39310
Dublin, Ireland
Milano, Italy, 20123
Napoli, Italy, 80131
Roma, Italy, 00161
Roma, Italy, 00186
Hospitalet de Llobregat, Barcelona, Spain, 08907
Barcelona, Spain, 08025
Madrid, Spain, 28007
Goteborg, Sweden, 41346
Malmo, Sweden, 20502
Stockholm, Sweden, 14186
United Kingdom
Reading, Berkshire, United Kingdom, RG2 7AG
Wigan, Manchester, United Kingdom, WN1 1XX
Cardiff, United Kingdom, CF14 5GJ
London, United Kingdom, EC1A 7BE
London, United Kingdom, NW3 2QG
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00185198     History of Changes
Other Study ID Numbers: 91297
2004-001545-15 ( EudraCT Number )
307720 ( Other Identifier: Company internal )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014

Keywords provided by Bayer:
Partial androgen deficiency of aging males (PADAM)

Additional relevant MeSH terms:
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents