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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

December 5, 2001
June 23, 2005
September 2001
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Complete list of historical versions of study NCT00027430 on Archive Site
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Androgen Replacement Therapy in Women With Hypopituitarism
TheraDerm Administration in Women With Hypopituitarism

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.

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.

Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Drug: TheraDerm
Not Provided
Lin E, McCabe E, Newton-Cheh C, Bloch K, Buys E, Wang T, Miller KK. Effects of transdermal testosterone on natriuretic peptide levels in women: a randomized placebo-controlled pilot study. Fertil Steril. 2012 Feb;97(2):489-93. doi: 10.1016/j.fertnstert.2011.11.001. Epub 2011 Dec 2.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2004
Not Provided

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
18 Years to 50 Years
United States
FD-R-1981-01, FD-R-001981-01
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FDA Office of Orphan Products Development
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Principal Investigator: Anne Klibanski, M.D. Massachusetts General Hospital
FDA Office of Orphan Products Development
November 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP