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	Treatment or Intervention
Hypopituitarism	Drug: TheraDerm

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.

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Female

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

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting

Study chairs or principal investigators

Anne Klibanski, M.D.,  Principal Investigator,  Massachusetts General Hospital   

Study ID Numbers:  FD-R-1981-01; FD-R-001981-01
Record last reviewed:  November 2001
Record first received:  December 5, 2001
ClinicalTrials.gov Identifier:  NCT00027430
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09