Testosterone Gel Applied to Women With Pituitary Gland Problems

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Charles Drew University of Medicine and Science.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00144391
First received: September 1, 2005
Last updated: February 23, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Panhypopituitarism
Drug: Transdermal Testosterone gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Physiologic Testosterone Replacement in Women With Hypopituitarism

Resource links provided by NLM:


Further study details as provided by Charles Drew University of Medicine and Science:

Primary Outcome Measures:
  • To determine the effects of physiologic testosterone replacement on subjective and objective measures of sexual function, cognitive function and quality of life in women with hypopituitarism [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the effects of physiologic testosterone replacement on fat-free mass, muscle strength, leg power, muscle fatigability, and physical function in women with hypopituitarism. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: July 2003
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months
Drug: Transdermal Testosterone gel
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144391

Contacts
Contact: Erik N Zuckerbraun, M.D. 310.668.8754 erikzuckerbraun@cdrewu.edu
Contact: Christian Gastelum, M.D. 310.668.8754 christiangastelum@cdrewu.edu

Locations
United States, California
Charles Drew University of Medicine and Science Recruiting
Los Angeles, California, United States, 90059
Principal Investigator: Theodore C Friedman, M.D., Ph.D.         
Sponsors and Collaborators
Charles Drew University of Medicine and Science
Investigators
Principal Investigator: Theodore C Friedman, M.D., Ph.D. Charles Drew University of Medicine and Science
  More Information

Additional Information:
No publications provided

Responsible Party: Theodore C. Friedman, M.D.,Ph.D. principal investigator, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00144391     History of Changes
Other Study ID Numbers: 03-02-511-07, 1U54HD41748-01
Study First Received: September 1, 2005
Last Updated: February 23, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypopituitarism
Dwarfism, Pituitary
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 28, 2014