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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	7 April 2015
Main ID:	NCT00027430
Date of registration:	05/12/2001
Prospective Registration:	No
Primary sponsor:	Massachusetts General Hospital
Public title:	Androgen Replacement Therapy in Women With Hypopituitarism
Scientific title:	TheraDerm Administration in Women With Hypopituitarism
Date of first enrolment:	September 2001
Target sample size:	50
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00027430
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Phase:	N/A

Countries of recruitment
United States

Contacts

Name:	Anne Klibanski, M.D.
Address:
Telephone:
Email:
Affiliation:	Massachusetts General Hospital

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Hypopituitarism

Intervention(s)

Drug: TheraDerm

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

FD-R-1981-01

FD-R-001981-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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