Overview

This trial is active, not recruiting.

Condition hypogonadism
Treatment testosterone gel wolff
Phase phase 3
Sponsor University Hospital Muenster
Collaborator Dr. August Wolff GmbH & Co
Start date January 2003
End date September 2006
Trial size 100 participants
Trial identifier NCT00204269, IRM 2002/37, TGT-04/2002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
testosterone levels
time frame:

Secondary Outcomes

Measure
hormones
time frame:
sexual function and mood disorder (questionnaire)
time frame:
compliance (drug accountability)
time frame:

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Three-Year Trial on a New Testosterone Gel: Clinical Efficacy, Tolerability and Compliance
Principal investigator Eberhard Nieschlag, Prof. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2006.
Information provided to ClinicalTrials.gov by University Hospital Muenster.