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Androgen Replacement Therapy in Women With Hypopituitarism

Primary Purpose

Hypopituitarism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TheraDerm
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypopituitarism

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 5, 2001
Last Updated
March 24, 2015
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00027430
Brief Title
Androgen Replacement Therapy in Women With Hypopituitarism
Official Title
TheraDerm Administration in Women With Hypopituitarism
Study Type
Interventional

2. Study Status

Record Verification Date
November 2001
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital

4. Oversight

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopituitarism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TheraDerm

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Klibanski, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22137497
Citation
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.
Results Reference
derived

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Androgen Replacement Therapy in Women With Hypopituitarism

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