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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00338312 |
This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin therapy.
Condition | Intervention | Phase |
---|---|---|
Hypoactive Sexual Desire Disorder |
Drug: Testosterone Transdermal System Drug: Placebo patch |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Study to Evaluate the Efficacy/Safety of Transdermal Testosterone for 52 Weeks and Safety for 52 Weeks in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder on Oral Hormone Replacement Therapy. |
Enrollment: | 610 |
Study Start Date: | June 2002 |
Study Completion Date: | July 2006 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Placebo patch
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Drug: Placebo patch
placebo patch changed twice a week for one year
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2: Experimental
testosterone patch (300 mcg/day) patch changed 2 times/week, for one year
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Drug: Testosterone Transdermal System
testosterone patch (300 mcg/day) patch changed 2 times/week, for one year
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Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients were stratified based on presence/absence of uterus and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen/progestin throughout the study. Patients who completed the first 52 weeks of the study were given the opportunity to participate in year 2-4 open-label (active treatment) study extension which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabois in evaluation, coagulation testing, and hermatology. Physical exam including clinical assessments of facial hair and acne were monitored.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible women must:
Exclusion Criteria:
Eligible women must not:
Responsible Party: | Procter and Gamble ( Johna Lucas, MD ) |
Study ID Numbers: | 2002005 and Yr 2-4 OL |
Study First Received: | June 15, 2006 |
Last Updated: | February 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00338312 |
Health Authority: | United States: Food and Drug Administration |
Natural 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 |