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

NCT00185198 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2014-04-02

No results posted yet for this study

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.

Conditions

  • Androgens (Deficiency)
  • Male

Interventions

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

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-09-30
Completion
2007-10-31

Countries

  • Austria
  • Finland
  • Germany
  • Ireland
  • Italy
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00185198 on ClinicalTrials.gov