Three-Year Trial on a New Testosterone Gel

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00204269
• Other study ID #: IRM 2002/37
• Secondary ID: TGT-04/2002
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 12, 2006
• Start date: January 2003
• Est. completion date: September 2006

Study information

• Verified date: May 2006
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone Gel Wolff

Locations

Country	Name	City	State
Germany	University Clinic Charité, Division of Urology	Berlin
Germany	Franziskus-Hospital, Division of Urology	Bielefeld
Germany	University Clinic Bonn, Division of Dermatology	Bonn
Germany	Medical University Clinic II, Division of Internal Medicine/Andrology	Cologne
Germany	University Clinic Essen, Division of Internal Medicine	Essen
Germany	J.-W. Goethe University, Medical Clinic I, Division of Internal Medicine	Frankfurt
Germany	University Clinic Giessen, Division of Dermatology/Andrology	Giessen
Germany	University Clinic Halle Wittenberg, Division of Urology/Andrology	Halle (Saale)
Germany	Endokrinologikum Hamburg	Hamburg
Germany	University Medical Clinic Hannover	Hannover
Germany	University Clinic Leipzig, Division of Dermatology/Andrology	Leipzig
Germany	Otto-von-Guerike-University, Clinic of Endocrinology	Magdeburg
Germany	Phillips-University-Clinic Marburg, Division of Dermatology/Andrology	Marburg
Germany	Insitute of Reproductive Medicine of the University	Muenster
Germany	Private Practice of Urology	Nuernberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Dr. August Wolff GmbH & Co. KG Arzneimittel

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kühnert B, Byrne M, Simoni M, Köpcke 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	testosterone levels
Secondary	hormones
Secondary	sexual function and mood disorder (questionnaire)
Secondary	compliance (drug accountability)