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

Male Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185198
• Other study ID #: 91297
• Secondary ID: 2004-001545-1530
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: April 1, 2014
• Start date: September 2004
• Est. completion date: October 2007

Study information

• Verified date: April 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenFinland: Finnish Medicines AgencyIreland: Irish Medicines BoardSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: October 2007
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Androgens (Deficiency)
• Male

Intervention

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
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean body mass at 6 months		baseline, month 6 and month 18	No
Secondary	Change in total body mass, fat mass and bone density		baseline, month 6 and month 18	No
Secondary	Evaluation of symptoms by the aging males symptoms rating scale		baseline, month 6 and month 18	No
Secondary	Change in testosterone		baseline, month 6 and month 18	No
Secondary	Safety parameters		baseline, month 6 and month 18	Yes

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