Androgen Replacement Therapy in Women With Hypopituitarism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027430
Recruitment Status : Completed
First Posted : December 7, 2001
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

December 5, 2001
December 7, 2001
March 25, 2015
September 2001
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00027430 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
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.

Completion date provided represents the completion date of the grant per OOPD records

Not Applicable
Allocation: Randomized
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.
Same as current
December 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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
Massachusetts General Hospital
Not Provided
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