Clinical trial NCT00185198: Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Androgens (Deficiency)
Male
Keywords: Partial androgen deficiency of aging males (PADAM)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 363
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Lean body mass at 6 months
timeFrame: baseline, month 6 and month 18
Secondary outcomes:
measure: Change in total body mass, fat mass and bone density
timeFrame: baseline, month 6 and month 18
measure: Evaluation of symptoms by the aging males symptoms rating scale
timeFrame: baseline, month 6 and month 18
measure: Change in testosterone
timeFrame: baseline, month 6 and month 18
measure: Safety parameters
timeFrame: baseline, month 6 and month 18
Other outcomes:
Locations:
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Helsinki
country: Finland
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Magdeburg
country: Germany
city: Dublin
country: Ireland
city: Milano
country: Italy
city: Napoli
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Goteborg
country: Sweden
city: Malmo
country: Sweden
city: Stockholm
country: Sweden
city: Reading
country: United Kingdom
state: Berkshire
city: Wigan
country: United Kingdom
state: Manchester
city: Cardiff
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: