NCT00144391

Testosterone Gel Applied to Women With Pituitary Gland Problems

Physiologic Testosterone Replacement in Women With Hypopituitarism

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Charles Drew University of Medicine and Science · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Panhypopituitarism

Interventions

Type	Name	Description
DRUG	Transdermal Testosterone gel	2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.

Timeline

• Start date: 2003-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2005-09-05
• Last updated: 2017-06-27
• Results posted: 2017-06-27

Locations

1 site across 1 country: United States