Three-Year Trial on a New Testosterone Gel

• Status: Unknown status
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Muenster
• Collaborator: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

men with

• hypergonadotropic hypogonadism

• hypogonadotropic hypogonadism

• late-onset hypogonadism

combined with an initial Testosterone serum level of < 11 nmol/l

Exclusion Criteria:

• known or suspected carcinoma of the prostate

• clinically relevant abnormalities in clinical chemistry or haematology

• any severe medical conditions at the opinion of the investigator