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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: | NCT00144391 |
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.
Condition | Intervention | Phase |
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Panhypopituitarism |
Drug: Transdermal Testosterone gel |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Physiologic Testosterone Replacement in Women With Hypopituitarism |
Estimated Enrollment: | 160 |
Study Start Date: | July 2003 |
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: Placebo Comparator
2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months
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Drug: Transdermal Testosterone gel
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.
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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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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:
Exclusion Criteria:
Contact: Erik N Zuckerbraun, M.D. | 310.668.8754 | erikzuckerbraun@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 | |
Principal Investigator: Theodore C Friedman, M.D., Ph.D. |
Principal Investigator: | Theodore C Friedman, M.D., Ph.D. | Charles R. Drew University |
Responsible Party: | Charles Drew University ( Theodore C. Friedman, M.D.,Ph.D. principal investigator ) |
Study ID Numbers: | 03-02-511-06, 1U54HD41748-01 |
Study First Received: | September 1, 2005 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00144391 |
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 |