Trial | NCT00204269  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    testosterone ...

  • Study Participants

    100
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.
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 Started
Jan 31
2003
Study Completion
Sep 30
2006
Last Update
May 15
2006
Estimate

Drug Testosterone Gel Wolff

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
No Results Posted