check_circleStudy Completed

Androgens (deficiency), Male

Bayer Identifier:

91297

ClinicalTrials.gov Identifier:

NCT00185198

EudraCT Number:

2004-001545-15

EU CT Number:

Not Available
Efficacy and safety of Testogel® in men with partial androgen deficiency of aging males (PADAM)

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

50 - 80 Years
  • - Symptomatic hypogonadism
    - Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study
  • - Patients with any contraindication for testosterone use

Trial summary

Enrollment Goal
363
Trial Dates
September 2004 - October 2007
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Testogel (Testosterone, BAYV001915)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Wien, 1021, Austria
Completed
Barcelona, 08025, Spain
Completed
Tampere, 33521, Finland
Completed
London, NW3 2QG, United Kingdom
Completed
Dublin, Ireland
Completed
Roma, 00168, Italy
Completed
Salzburg, 5020, Austria
Completed
Oulu, 90100, Finland
Completed
Goteborg, 41346, Sweden
Completed
Innsbruck, 6020, Austria
Completed
Madrid, 28007, Spain
Completed
Helsinki, 00260, Finland
Completed
Milano, 20123, Italy
Completed
Malmo, 20502, Sweden
Completed
Leipzig, 04103, Germany
Completed
Wigan, WN1 1XX, United Kingdom
Completed
Halle, 06112, Germany
Completed
Stockholm, 14186, Sweden
Completed
Reading, RG2 7AG, United Kingdom
Completed
Bonn, 53105, Germany
Completed
Sheffield, S5 7AU, United Kingdom
Completed
Graz, 8036, Austria
Completed
London, EC1A 7BE, United Kingdom
Completed
Napoli, 80131, Italy
Completed
Magdeburg, 39310, Germany
Completed
Dresden, 01067, Germany
Completed
Cardiff, CF14 5GJ, United Kingdom
Completed
Roma, 00186, Italy
Completed
Hospitalet de Llobregat, 08907, Spain
Completed
Wien, 1090, Austria

Primary Outcome

  • Lean body mass at 6 months
    date_rangeTime Frame:
    baseline, month 6 and month 18
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Change in total body mass, fat mass and bone density
    date_rangeTime Frame:
    baseline, month 6 and month 18
    enhanced_encryption
    Safety Issue:
    no
  • Evaluation of symptoms by the aging males symptoms rating scale
    date_rangeTime Frame:
    baseline, month 6 and month 18
    enhanced_encryption
    Safety Issue:
    no
  • Change in testosterone
    date_rangeTime Frame:
    baseline, month 6 and month 18
    enhanced_encryption
    Safety Issue:
    no
  • Safety parameters
    date_rangeTime Frame:
    baseline, month 6 and month 18
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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