Three-Year Trial on a New Testosterone Gel

Phase 3

• Conditions: Hypogonadism

• Registration Number: NCT00204269
• Lead Sponsor: University Hospital Muenster

Brief 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.

Detailed Description

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 (TGW).

A minimum of 100 patients will be recruited and evenly distributed to two treatment arms. 1st arm: dermal (non-scrotal) application of TGW. 2nd arm: scrotal application of TGW.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2006-05
• Last Update Submitted: 2006-05-12
• Last Update Posted: 2006-05-15
• Study Completion: 2006-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
testosterone levels

Secondary Outcome Measures

Name	Time	Method
sexual function and mood disorder (questionnaire)
hormones
compliance (drug accountability)

Trial Locations

Locations (15)

University Clinic Essen, Division of Internal Medicine; 🇩🇪 Essen, Germany

University Clinic Giessen, Division of Dermatology/Andrology; 🇩🇪 Giessen, Germany

Private Practice of Urology; 🇩🇪 Nuernberg, Germany

University Medical Clinic Hannover; 🇩🇪 Hannover, Germany

University Clinic Bonn, Division of Dermatology; 🇩🇪 Bonn, Germany

University Clinic Charité, Division of Urology; 🇩🇪 Berlin, Germany

Franziskus-Hospital, Division of Urology; 🇩🇪 Bielefeld, Germany

Medical University Clinic II, Division of Internal Medicine/Andrology; 🇩🇪 Cologne, Germany

Endokrinologikum Hamburg; 🇩🇪 Hamburg, Germany

J.-W. Goethe University, Medical Clinic I, Division of Internal Medicine; 🇩🇪 Frankfurt, Germany

University Clinic Halle Wittenberg, Division of Urology/Andrology; 🇩🇪 Halle (Saale), Germany

Insitute of Reproductive Medicine of the University; 🇩🇪 Muenster, Germany

Phillips-University-Clinic Marburg, Division of Dermatology/Andrology; 🇩🇪 Marburg, Germany

Otto-von-Guerike-University, Clinic of Endocrinology; 🇩🇪 Magdeburg, Germany

University Clinic Leipzig, Division of Dermatology/Andrology; 🇩🇪 Leipzig, Germany