Three-Year Trial on a New Testosterone Gel

Condition(s) targeted: Hypogonadism

Intervention: Testosterone Gel Wolff (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University Hospital Muenster

Official(s) and/or principal investigator(s):
Eberhard Nieschlag, Prof. Dr., Principal Investigator, Affiliation: Institute of Reproductive Medicine of the University

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.

Official title: Three-Year Trial on a New Testosterone Gel: Clinical Efficacy, Tolerability and Compliance

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: testosterone levels

Secondary outcome:

hormones

sexual function and mood disorder (questionnaire)

compliance (drug accountability)

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Insitute of Reproductive Medicine of the University, Muenster 48129, Germany

Franziskus-Hospital, Division of Urology, Bielefeld 33615, Germany

Medical University Clinic II, Division of Internal Medicine/Andrology, Cologne 50924, Germany

University Clinic Bonn, Division of Dermatology, Bonn 53105, Germany

University Clinic Essen, Division of Internal Medicine, Essen 45147, Germany

University Clinic Halle Wittenberg, Division of Urology/Andrology, Halle (Saale) 06120, Germany

Endokrinologikum Hamburg, Hamburg 22767, Germany

University Medical Clinic Hannover, Hannover 30625, Germany

University Clinic Leipzig, Division of Dermatology/Andrology, Leipzig 04103, Germany

University Clinic Charité, Division of Urology, Berlin 10117, Germany

Phillips-University-Clinic Marburg, Division of Dermatology/Andrology, Marburg 35037, Germany

Private Practice of Urology, Nuernberg 90441, Germany

Otto-von-Guerike-University, Clinic of Endocrinology, Magdeburg 39120, Germany

J.-W. Goethe University, Medical Clinic I, Division of Internal Medicine, Frankfurt 60590, Germany

University Clinic Giessen, Division of Dermatology/Andrology, Giessen 35385, Germany

Related publications:

Kuhnert B, Byrne M, Simoni M, Kopcke W, Gerss J, Lemmnitz G, Nieschlag E. Testosterone substitution with a new transdermal, hydroalcoholic gel applied to scrotal or non-scrotal skin: a multicentre trial. Eur J Endocrinol. 2005 Aug;153(2):317-26.

Starting date: January 2003
Ending date: September 2006
Last updated: May 12, 2006