Androgen Replacement Therapy in Women With Hypopituitarism

TheraDerm Administration in Women With Hypopituitarism

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00027430

Enrollment

Registered

2001-12-07

Start date

2001-09-30

Completion date

2004-12-31

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopituitarism

Brief summary

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.

Detailed 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

Interventions

DRUGTheraDerm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026