ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00027430
Recruitment Status : Completed
First Posted : December 7, 2001
Last Update Posted : March 25, 2015
Sponsor:
Information provided by:
FDA Office of Orphan Products Development

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.

Condition or disease Intervention/treatment Phase
Hypopituitarism Drug: TheraDerm Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: TheraDerm Administration in Women With Hypopituitarism
Study Start Date : September 2001
Study Completion Date : December 2004






Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027430


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Anne Klibanski, M.D. Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00027430     History of Changes
Other Study ID Numbers: FD-R-1981-01
FD-R-001981-01
First Posted: December 7, 2001    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: November 2001

Additional relevant MeSH terms:
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases