Three-Year Trial on a New Testosterone Gel

University Hospital Muenster

Status and phase: Unknown; Phase 3

Conditions: Hypogonadism

Treatments: Drug: Testosterone Gel Wolff

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00204269

IRM 2002/37

TGT-04/2002

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)