Androgen Replacement Therapy in Women With Hypopituitarism

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, November 2001

Sponsored by:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00027430

Purpose

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.

Condition	Intervention
Hypopituitarism	Drug: TheraDerm

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	TheraDerm Administration in Women With Hypopituitarism

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	50
Study Start Date:	September 2001
Estimated Study Completion Date:	August 2004

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027430

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anne Klibanski, M.D. 617-726-3870
Principal Investigator: Anne Klibanski, M.D.

Sponsors and Collaborators

FDA Office of Orphan Products Development

Investigators

Principal Investigator:

Anne Klibanski, M.D.

Massachusetts General Hospital

More Information

Study ID Numbers:	FD-R-1981-01, FD-R-001981-01
Study First Received:	December 5, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00027430
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypothalamic Diseases
Pituitary Diseases
Hypopituitarism
Endocrine System Diseases

Central Nervous System Diseases
Endocrinopathy
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009