Testosterone Gel Applied to Women With Pituitary Gland Problems

NCT00144391 | Completed Phase 4 Results DMC

• 2 other identifiers: 03-02-511-071U54HD041748-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Panhypopituitarism

Outcome Measures

Primary Outcomes (1)

• Fatigue Impact Scale

  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

Study Arms (2)

Transdermal Testosterone Gel

EXPERIMENTAL

Transdermal Testosterone Gel (2 mg per pump), 2 pumps per day for 6 months

Drug: Transdermal Testosterone gel

Placebo

PLACEBO COMPARATOR

Placebo 2 pumps per day for 6 months

Drug: Transdermal Testosterone gel

Interventions

Transdermal Testosterone gel DRUG

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; Transdermal Testosterone Gel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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).
• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Charles Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

Related Links

• Clinical Trial Research site

MeSH Terms

Conditions

Combined Pituitary Hormone Deficiency

Limitations and Caveats

Small number of patients recruited.

Results Point of Contact

• Title: Dr. Theodore Friedman
• Organization: Charles R. Drew University of Medicine and Science

theodorefriedman@cdrewu.edu

310-668-5197

Study Officials

• Theodore C Friedman, M.D., Ph.D.

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Testosterone and Placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Testosterone and Placebo

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: July 1, 2003
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 27, 2017
• Results First Posted: June 27, 2017

Record last verified: 2017-04

Locations

US (1)