Androgen Replacement Therapy in Women With Hypopituitarism

Mass General Brigham

Status: Completed

Conditions: Hypopituitarism

Treatments: Drug: TheraDerm

Study type: Interventional

Funder types: Other

Identifiers

NCT00027430

FD-R-001981-01

FD-R-1981-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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