Androgen Replacement Therapy in Women With Hypopituitarism

Massachusetts General Hospital50 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Hypopituitarism

Interventions

TheraDermDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Data from ClinicalTrials.gov

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