Baseline Sexual Function, Cognitive Function, Body Composition and Muscle Parameters and Pharmaco… (NCT00144404) | Clinical Trial Compass
WithdrawnNot Applicable
Baseline Sexual Function, Cognitive Function, Body Composition and Muscle Parameters and Pharmacokinetics of Transdermal Testosterone Gel in Women With Hypopituitarism
Stopped: this was not a clinical trial
United States0Started 2002-08
Plain-language summary
The purpose of this study is to determine the blood levels of testosterone gel administered for a week to women with hypopituitarism and determine if this leads to testosterone replacement in a normal range for women. An additional objective is to determine the baseline laboratory abnormalities and physical, brain function, emotional and sexual symptomatology of these women with hypopituitarism.
Who can participate
Age range18 Years – 55 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women age 18-55
* Hypopituitarism with documented central adrenal and gonadal deficiencies. Serum testosterone level of \< 20 ng/dl or free testosterone \<1.5 pg/ml on conjugated equine estrogen replacement
* 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, renal disease (creatinine \> 1.5 mg/dL), diabetes mellitus, 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 or uterine cancer
* Those with significant liver function abnormalities defined as SGOT, SGPT or alkaline phosphatase value of greater than one and one-half times 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 hirsutis…
What they're measuring
1
The purpose of this study is to determine the pharmacokinetics of testosterone gel 2 mg/d administered for a week to women with hypopituitarism and determine if this leads to testosterone replacement in a physiologic range.
Timeframe: 6 weeks
Trial details
NCT IDNCT00144404
SponsorCharles Drew University of Medicine and Science