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

April 1, 2014 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

363

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lean body mass at 6 months
Time Frame: baseline, month 6 and month 18
baseline, month 6 and month 18

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (ACTUAL)

September 1, 2006

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (ESTIMATE)

September 16, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91297
  • 2004-001545-15 (EUDRACT_NUMBER)
  • 307720 (OTHER: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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