Trial Condition(s):
Androgens (deficiency), Male
Efficacy and safety of Testogel® in men with partial androgen deficiency of aging males (PADAM)
Bayer Identifier:
91297
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Wien, Austria, 1021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampere, Finland, 33521 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, NW3 2QG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dublin, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salzburg, Austria, 5020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Goteborg, Sweden, 41346 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00260 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Malmo, Sweden, 20502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wigan, United Kingdom, WN1 1XX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halle, Germany, 06112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 14186 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reading, United Kingdom, RG2 7AG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sheffield, United Kingdom, S5 7AU | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, EC1A 7BE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Magdeburg, Germany, 39310 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01067 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cardiff, United Kingdom, CF14 5GJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00186 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Lean body mass at 6 monthsTimeframe: baseline, month 6 and month 18
Secondary Outcome
- Change in total body mass, fat mass and bone densityTimeframe: baseline, month 6 and month 18
- Evaluation of symptoms by the aging males symptoms rating scaleTimeframe: baseline, month 6 and month 18
- Change in testosteroneTimeframe: baseline, month 6 and month 18
- Safety parametersTimeframe: baseline, month 6 and month 18
Additional Information
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