Clinical Trial: Androgen Replacement Therapy in Women With Hypopituitarism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: TheraDerm Administration in Women With Hypopituitarism

Brief 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.

Detailed Summary:

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

Sponsor: Massachusetts General Hospital

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: FDA Office of Orphan Products Development

Dates:
Date Received: December 5, 2001
Date Started: September 2001
Date Completion: December 2004
Last Updated: March 24, 2015
Last Verified: November 2001