- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00144391
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:
- 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.
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.
Collaborators
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.
Helpful Links
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Panhypopituitarism
-
Charles Drew University of Medicine and ScienceWithdrawn
-
Ohio State UniversityNationwide Children's HospitalCompletedGrowth Hormone Deficiency | Panhypopituitarism | Short StatureUnited States
-
Seoul National University HospitalRecruitingCraniopharyngioma | Panhypopituitarism | Hypothalamic ObesityKorea, Republic of
-
Fundació Institut de Recerca de l'Hospital de la...Instituto de Salud Carlos IIIRecruitingPituitary Diseases | Hypothalamic Diseases | Hypopituitarism | Social Isolation | Panhypopituitarism | Psychological Disorder | Central Diabetes Insipidus | Oxytocin DeficiencySpain
-
Fundació Institut de Recerca de l'Hospital de la...Instituto de Salud Carlos IIIRecruitingPituitary Diseases | Hypothalamic Diseases | Hypopituitarism | Social Isolation | Panhypopituitarism | Psychological Disorder | Central Diabetes Insipidus | Oxytocin DeficiencySpain
-
Eunice Kennedy Shriver National Institute of Child...RecruitingCushing Disease | Prolactinoma | Panhypopituitarism | Gigantism/AcromegalyUnited States
Clinical Trials on Transdermal Testosterone gel
-
BioSante PharmaceuticalsCompletedHypoactive Sexual Desire DisorderUnited States, Canada
-
Manchester University NHS Foundation TrustBayer; University of ManchesterCompleted
-
Hanoi Medical UniversityNational Hospital of Obstetrics and GynecologyCompleted
-
Gulhane School of MedicineCompletedHypogonadotrophic HypogonadismTurkey
-
Gulhane School of MedicineCompletedHypogonadotrophic HypogonadismTurkey
-
Lamm, Steven, M.D.Solvay PharmaceuticalsCompletedHypogonadismUnited States
-
Gulhane School of MedicineCompletedSecondary HypogonadismTurkey
-
Clarus Therapeutics, Inc.CompletedMale HypogonadismUnited States, Germany
-
University of WashingtonNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedHealthyUnited States
-
Zynerba Pharmaceuticals, Inc.Enrolling by invitationFragile X SyndromeUnited States, United Kingdom, New Zealand, Australia