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Sponsored by: |
Charles Drew University of Medicine and Science |
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Information provided by: | Charles Drew University of Medicine and Science |
ClinicalTrials.gov Identifier: | NCT00144404 |
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.
Condition | Intervention | Phase |
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Panhypopituitarism |
Drug: Transdermal Testosterone Gel |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Baseline Sexual Function, Cognitive Function, Body Composition and Muscle Parameters and Pharmacokinetics of Transdermal Testosterone Gel in Women With Hypopituitarism |
Estimated Enrollment: | 50 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pharmacokinetic study of transdermal testosterone gel-study groups of (8 pumps, 12 pumps, 16 pumps)
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Drug: Transdermal Testosterone Gel
2.0 mg per pump of testosterone gel (8 pumps, 12 pumps, 16 pumps). Pharmacokinetic study
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The ovaries and the adrenal glands contribute to the daily production of 300 micrograms of testosterone in healthy, menstruating women. The physiologic role of testosterone in women, however, remains poorly understood. Previous studies of testosterone supplementation, largely in surgically or naturally menopausal women, have reported improvements in subjective measures of sexual function, sense of well being, and variable changes in markers of bone formation and resorption. However, many of these previous studies used supraphysiologic doses of testosterone, and insensitive assays for the measurement of total and free testosterone levels that lacked precision and accuracy in the low range prevalent in women. The effects of testosterone in women on body composition, muscle performance and physical function have not been studied. Therefore, the clinical significance of androgen deficiency in women remains unclear. Thus, we do not know whether physiologic testosterone replacement of women with androgen deficiency can produce clinically meaningful improvements in sexual and cognitive functions, fat-free mass, and muscle performance, without virilizing side effects.
Women with hypopituitarism represent an excellent model to study the effects of physiologic replacement as these patients have severely diminished androgen production from both the adrenal glands and the ovaries. Estrogen administration, by increasing sex hormone binding globulin (SHBG) in these women leads to further reduction in free testosterone concentrations. In fact, a recent study demonstrated very low levels of total and free testosterone, dehydroepiandrosterone sulfate (DHEAS), its parent steroid dehydroepiandrosterone (DHEA), and androstenedione in women with hypopituitarism. Therefore, it is postulated that many women with hypopituitarism suffer from decreased libido, altered body composition, and impaired quality of life, symptoms possibly related to androgen deficiency. However, these parameters have not been properly studied in a well-defined group of women with hypopituitarism. These baseline studies are needed prior to undertaking a study on treating women with hypopituitarism with a testosterone preparation.
Prior to investigating testosterone replacement in a large study of women with hypopituitarism, we must first determine in this pilot study the amount and interval of testosterone administration.
Currently, the only FDA-approved drug for testosterone in women is Estratest, which contains methyl testosterone, a compound that when given orally is associated with liver toxicity in animals and humans. Until recently, most hypogonadal men received biweekly intramuscular injections of testosterone. This regimen gives variable serum testosterone levels depending on the time of the blood sampling compared to the time of injection. Many male hypogonadal patients now receive their testosterone replacement via either transdermal testosterone gel or patch, with much more uniform serum testosterone levels. We have chosen transdermal testosterone gel for use in this study for several reasons:
Thus, we will use transdermal testosterone gel as it provides predictable and physiologic levels of testosterone.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erik Zuckerbraun, M.D. | 310.668.8754 | erzucker@cdrewu.edu |
Contact: Christian Gastelum, M.D. | 310.668.8754 | christiangastelum@cdrewu.edu |
United States, California | |
Charles R. Drew University | Recruiting |
Los Angeles, California, United States, 90059 | |
Contact: Erik Zuckerbraun, M.D. 310-668-8754 erzucker@cdrewu.edu | |
Contact: Christian Gastelum, M.D. 310.668.8754 christiangastelum@cdrewu.edu | |
Principal Investigator: Ted C Friedman, M.D., Ph.D. |
Principal Investigator: | Ted C Friedman, M.D., Ph.D. | Charles R. Drew University |
Responsible Party: | Charles R. Drew University ( Theodore C. Friedman, M.D., Ph.D. Principal Investigator ) |
Study ID Numbers: | 02-04-376-06 |
Study First Received: | September 1, 2005 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00144404 |
Health Authority: | United States: Institutional Review Board |
Hypothalamic Diseases Testosterone Pituitary Diseases Hypopituitarism Endocrine System Diseases Central Nervous System Diseases |
Methyltestosterone Endocrinopathy Panhypopituitarism Brain Diseases Testosterone 17 beta-cypionate |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |