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 range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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