Androgen Replacement Therapy in Women With Hypopituitarism

Completed · Not applicable

Conditions studied: Hypopituitarism

In brief

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.

Key facts

Study ID

NCT00027430

Run by

Massachusetts General Hospital

People needed

50

Starts

2001-09-01

Expected to finish

2004-12-01

Last updated by the study team

2015-03-25

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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