Androgen Replacement Therapy in Women With Hypopituitarism

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.

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