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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00185198
First received: September 9, 2005
Last updated: April 1, 2014
Last verified: April 2014
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in total body mass, fat mass and bone density [ Time Frame: baseline, month 6 and month 18 ] [ Designated as safety issue: No ]
  • Evaluation of symptoms by the aging males symptoms rating scale [ Time Frame: baseline, month 6 and month 18 ] [ Designated as safety issue: No ]
  • Change in testosterone [ Time Frame: baseline, month 6 and month 18 ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: baseline, month 6 and month 18 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00185198

Locations
Austria
Graz, Austria, 8036
Innsbruck, Austria, 6020
Salzburg, Austria, 5020
Wien, Austria, 1021
Wien, Austria, 1090
Finland
Helsinki, Finland, 00260
Oulu, Finland, 90100
Tampere, Finland, 33521
Germany
Bonn, Nordrhein-Westfalen, Germany, 53105
Halle, Sachsen-Anhalt, Germany, 06112
Dresden, Sachsen, Germany, 01067
Leipzig, Sachsen, Germany, 04103
Magdeburg, Germany, 39310
Ireland
Dublin, Ireland
Italy
Milano, Italy, 20123
Napoli, Italy, 80131
Roma, Italy, 00161
Roma, Italy, 00186
Spain
Hospitalet de Llobregat, Barcelona, Spain, 08907
Barcelona, Spain, 08025
Madrid, Spain, 28007
Sweden
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, NW3 2QG
London, United Kingdom, EC1A 7BE
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185198     History of Changes
Other Study ID Numbers: 91297, 2004-001545-15, 307720
Study First Received: September 9, 2005
Last Updated: April 1, 2014
Health Authority: Austria: Federal Ministry for Health and Women
Finland: Finnish Medicines Agency
Ireland: Irish Medicines Board
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on September 18, 2014