Testosterone Gel Applied to Women With Pituitary Gland Problems

Panhypopituitarism Clinical Trial

Official title: Physiologic Testosterone Replacement in Women With Hypopituitarism

Status Recruiting

Clinical Trial Summary

The principal aim of this study is to evaluate if application of testosterone gel leads to improvement in measures of sexual function, thinking ability and quality of life in women with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of testosterone replacement on body composition and muscle function and strength.

Clinical Trial Description

Testosterone is the principal male sex hormone but is also present in smaller amounts in women and may be important for their health. Among its likely actions in women are the building of bone and muscle mass, increase in interest in sex (libido) and effects on the mood. Testosterone is commercially available as a hormone replacement therapy for males with an absence or lack of testosterone production. Testosterone for males is mainly given in the form of shots or skin patches which have certain disadvantages such as pain from shots and skin rashes from patches. It is anticipated that this experimental gel application will produce levels of the drug in the normal range in women. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panhypopituitarism

• NCT number: NCT00144391
• Study type: Interventional
• Source: Charles Drew University of Medicine and Science
• Contact: Erik N Zuckerbraun, M.D.
• Phone: 310.668.8754
• Email: erikzuckerbraun@cdrewu.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: July 2003
• Completion date: December 2010