Androgen Replacement Therapy in Women With Hypopituitarism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2004-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hypopituitarism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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TheraDerm

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No