Androgen Replacement Therapy in Women With Hypopituitarism

Status Completed

Clinical Trial Summary

This is a study to determine whether testosterone replacement with TheraDerm can improve bone density, mood, sex drive, thinking, and distribution of body fat and muscle mass in women with hypopituitarism.

Clinical Trial Description

Patients will be randomized into 2 groups to receive testosterone replacement therapy or placebo. Group 1 will receive 2 testosterone patches and estrogen pills for 12 months. Group 2 will receive 2 placebo patches and estrogen pills for 12 months. Changes in bone density, bone metabolism markers, body composition, libido, and quality of life will be compared in the women receiving testosterone replacement therapy with that of the women receiving placebo.

Completion date provided represents the completion date of the grant per OOPD records ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Hypopituitarism

Clinical Trial Details

NCT number	NCT00027430
Study type	Interventional
Source	FDA Office of Orphan Products Development
Contact
Status	Completed
Phase	N/A
Start date	September 2001
Completion date	December 2004

View Details

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