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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00331123 |
This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in surgically menopausal women who are taking estrogen therapy.
Condition | Intervention | Phase |
---|---|---|
Hypoactive Sexual Desire Disorder |
Drug: Testosterone Transdermal System Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Study to Evaluate Efficacy and Safety of Transdermal Testosterone and Safety for an Open-Label Period in Women With Hypoactive Sexual Desire Disorder on Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy. |
Enrollment: | 562 |
Study Start Date: | May 2002 |
Study Completion Date: | July 2006 |
Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Sham Comparator
Placebo patch
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Drug: Placebo
placebo patch,changed every 3-4 days for 6 months in the double blind portion
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2: Experimental
testosterone patch
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Drug: Testosterone Transdermal System
testosterone patch, 300mcg/day for 24 weeks
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Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 52-week, multicenter, multinational study that included a 24-week, double-blind (DB), parallel-group, placebo-controlled period followed by a 28-week open-label (OL) period. Patients were stratified based on their use of oral or transdermal ET and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen throughout the study. Upon completion of the DB period, patients receiving placebo were switched to TTS, while the active cohort remained on active treatment. All patients were then followed for an additional 28 weeks for safety. Patients who completed the first 52 weeks of the study were given the opportunity to participate in an open label extension (Years 2, 3 , and 4), which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, coagulation testing, and hematology. Physical exam including clinical assessments of facial hair and acne were monitored.
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible women must:
Exclusion Criteria:
Eligible women must not:
United States, Missouri | |
Research Site | |
Kansas City, Missouri, United States | |
Australia, Victoria | |
Research Site | |
Prahran, Victoria, Australia | |
Canada | |
Research Site | |
Quebec, Canada |
Study Director: | Johna Lucus, MD | Procter and Gamble |
Responsible Party: | Procter and Gamble ( Johna Lucas, MD ) |
Study ID Numbers: | 2001133 and Yr 2-4 OL |
Study First Received: | May 26, 2006 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00331123 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration |
Surgical menopause HSDD |
Sexual Dysfunctions, Psychological Signs and Symptoms Testosterone Mental Disorders Neurologic Manifestations |
Methyltestosterone Hypokinesia Dyskinesias Menopause Testosterone 17 beta-cypionate |
Disease Antineoplastic Agents, Hormonal Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Sexual and Gender Disorders |
Hormones Pharmacologic Actions Anabolic Agents Pathologic Processes Therapeutic Uses Androgens |