Testosterone Gel Applied to Women With Pituitary Gland Problems

May 25, 2017 updated by: Theodore Friedman, Charles Drew University of Medicine and Science

Physiologic Testosterone Replacement in Women With Hypopituitarism

The principal aim of this study is to evaluate if application of testosterone gel leads to improvement in measures of sexual function, thinking ability and quality of life in women with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of testosterone replacement on body composition and muscle function and strength.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Testosterone is the principal male sex hormone but is also present in smaller amounts in women and may be important for their health. Among its likely actions in women are the building of bone and muscle mass, increase in interest in sex (libido) and effects on the mood. Testosterone is commercially available as a hormone replacement therapy for males with an absence or lack of testosterone production. Testosterone for males is mainly given in the form of shots or skin patches which have certain disadvantages such as pain from shots and skin rashes from patches. It is anticipated that this experimental gel application will produce levels of the drug in the normal range in women.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90059
        • Charles Drew University of Medicine and Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women age 18-55
  • Hypopituitarism with central adrenal and/or gonadal deficiencies. To qualify patients will need to have either 1 or 2 and they need to have 3:

    1. To diagnose central adrenal deficiency, patients not on glucocorticoid replacement will have an insulin tolerance test (ITT) (patients with cardiovascular disease will be excluded) in which 0.1U/kg of insulin will be given by iv and a peak cortisol value of less than 20ug/dl, associated with a glucose level of less than 40mg/dL will be considered consistent with central adrenal insufficiency. Patients on glucocorticoid replacement will be evaluated by examining their prior workup and if it is determined that they had evidence of central adrenal deficiency, an ITT will not be required to document central adrenal deficiency (an ITT will still be performed to determine GH deficiency).
    2. To diagnose central gonadal deficiency, patients will be asked if they had amenorrhea or oligomenorrhea prior to estrogen replacement. An FAH of less than 5 MIU/ML will be used to confirm that they have central and not primary gonadal deficiency. In select patients in which the diagnosis of central gonadal deficiency is unclear, we may perform an LHRH stimulation test, in which 100 ug iv of LHRH (Factrel) will be given and a peak LH response of less than 15 MIU/ML will be considered consistent with central gonadotropin insufficiency.
    3. Serum testosterone level on transdermal estrogen replacement of less than 20 ng/dL or free testosterone of less than 1.5 pg/ml.
  • No other significant medical condition
  • Weight between 80 and 150% of ideal body weight
  • Able to provide informed consent
  • All races and ethnicities
  • All patients regardless of marital status and relationship status.

Exclusion Criteria:

  • Physical disabilities that would prevent them from participating in the study.
  • Current use of testosterone or other androgenic steroids. Patients who are taking testosterone, DHEA or other androgen precursors will discontinue these medications/supplements three months prior to the study.
  • Significant cardiopulmonary disease (prior myocardial infarction causing ventricular dysfunction, angina, arrhythmias, congestive heart failure, valvular problem), venous thrombotic event (pulmonary embolism or deep vein thrombosis), renal disease (creatinine greater than 1.5 mg/dL), diabetes mellitus on insulin, uncontrolled hypertension, malignancy (other than basal cell skin carcinoma) or major psychiatric disease. Patients with depression or anxiety on a stable dose of medication will be allowed to enroll.
  • Current abuse of illicit drugs or heavy ethanol use.
  • History of breast cancer or abnormal mammogram at entry. If patients with an abnormal mammogram or PAP smear are appropriately evaluated and found not to have cancer, they will be allowed to participate in the study.
  • Those with significant liver function abnormalities defined as SGOT, SGPT or alkaline phosphatase value of greater than one and one-half the upper limit of normal in our Clinical Pathology Laboratory or serum bilirubin levels of greater than 2 mg/dL will be excluded.
  • Those with history of hyperandrogenic disorders such as hirsutism and polycystic ovary disease will be excluded. These conditions are rare in women with hypopituitarism. Testosterone administration to these patients may exacerbate the underlying disorder.
  • Women who are pregnant, seeking to become pregnant in the next 6 months, or breast-feeding.
  • Those who have previously experienced intolerance to other transdermal systems or gels
  • Drugs known to alter testosterone production such as megace or ketoconazole.
  • Patients with untreated hyperprolactinemia or active Cushing's disease. Patients with treated prolactinoma or Cushing's disease will be allowed to participate in the study.
  • Hematocrit of greater than 50%
  • Male sex
  • Not willing to answer all questions on surveys
  • EKG showing ischemia or prior myocardial infarction
  • Patients with extensive brain surgery, severe head injury, brain tumors or other conditions that profoundly affect CNS function.
  • Patients not willing to be placed on a standardized hormonal replacement regimen including transdermal estrogen and growth hormone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transdermal Testosterone Gel
Transdermal Testosterone Gel (2 mg per pump), 2 pumps per day for 6 months
2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.
Placebo Comparator: Placebo
Placebo 2 pumps per day for 6 months
2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Impact Scale
Time Frame: 6 months
change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Theodore C Friedman, M.D., Ph.D., Charles Drew University of Medicine and Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 03-02-511-07
  • 1U54HD041748-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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