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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185198

Enrollment

363

Registered

2005-09-16

Start date

2004-09-30

Completion date

2007-10-31

Last updated

2014-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgens (Deficiency), Male

Keywords

Partial androgen deficiency of aging males (PADAM)

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.

Interventions

DRUGTestogel (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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Lean body mass at 6 months	baseline, month 6 and month 18

Secondary

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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026