Androgen Replacement Therapy in Women With Hypopituitarism

Hypopituitarism Clinical Trial

Official title:

TheraDerm Administration in Women With Hypopituitarism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027430
• Other study ID #: FD-R-1981-01
• Secondary ID: FD-R-001981-01
• Status: Completed
• Phase: N/A
• First received: December 5, 2001
• Last updated: March 24, 2015
• Start date: September 2001
• Est. completion date: December 2004

Study information

• Verified date: November 2001
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion criteria:

• Hypogonadism and/or hypoadrenalism of central origin

• Testosterone or free testosterone level below the median for age-matched normal controls

• Prior estrogen preparation for at least 6 months

Exclusion criteria:

• Any disease known to affect bone metabolism, including untreated hypothyroidism or hyperthyroidism

• Change in thyroid hormone dose in the last 3 months

• Untreated Cushing's syndrome

• Renal failure

• Alcoholism

• Anorexia nervosa

• Prior use of medication known to affect bone metabolism (e.g., supraphysiologic doses of glucocorticoids, phenytoin, bisphosphonates, or calcitonin) within the past 3 months

• Pregnant or nursing

• Uncontrolled hypertension

• ALT greater than 3 times upper limit of normal

• Serum creatinine greater than 2 times the upper limit of normal

• Any contraindication to estrogen therapy, including history of breast cancer or undiagnosed uterine bleeding

• Concurrent growth hormone replacement therapy, if patient has been receiving it for less than 2 years

Study Design

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

Related Conditions & MeSH terms

• Hypopituitarism

Intervention

Drug:
• TheraDerm

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States,