Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Androgen Replacement Therapy in Women With Hypopituitarism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: December 5, 2001
Last updated: June 23, 2005
Last verified: November 2001

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.

Condition Intervention
Drug: TheraDerm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: TheraDerm Administration in Women With Hypopituitarism

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 50
Study Start Date: September 2001
Estimated Study Completion Date: August 2004
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.


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00027430

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anne Klibanski, M.D.    617-726-3870      
Principal Investigator: Anne Klibanski, M.D.         
Sponsors and Collaborators
Principal Investigator: Anne Klibanski, M.D. Massachusetts General Hospital
  More Information

No publications provided by FDA Office of Orphan Products Development

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00027430     History of Changes
Other Study ID Numbers: FD-R-1981-01, FD-R-001981-01
Study First Received: December 5, 2001
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hypothalamic Diseases
Nervous System Diseases
Pituitary Diseases processed this record on March 03, 2015