This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 9, 2005
Last updated: April 1, 2014
Last verified: April 2014
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 Intervention Phase
Androgens (Deficiency) Male Drug: Testogel (Testosterone, BAYV001915) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Lean body mass at 6 months [ Time Frame: baseline, month 6 and month 18 ]

Secondary Outcome Measures:
  • Change in total body mass, fat mass and bone density [ Time Frame: baseline, month 6 and month 18 ]
  • Evaluation of symptoms by the aging males symptoms rating scale [ Time Frame: baseline, month 6 and month 18 ]
  • Change in testosterone [ Time Frame: baseline, month 6 and month 18 ]
  • Safety parameters [ Time Frame: baseline, month 6 and month 18 ]

Enrollment: 363
Study Start Date: September 2004
Study Completion Date: October 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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 )
Study First Received: September 9, 2005
Last Updated: April 1, 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 processed this record on September 21, 2017