Androgen Replacement Therapy in Women With Hypopituitarism

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital

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