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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00131495 |
This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy.
Condition | Intervention | Phase |
---|---|---|
Hypoactive Sexual Desire Disorder |
Drug: Testosterone (transdermal patches) Drug: Placebo patch |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 52-Week Study to Evaluate the Efficacy/Safety of Transdermal Patches Delivering Testosterone in Menopausal Women With Low Libido Not Receiving Estrogen Therapy |
Enrollment: | 814 |
Study Start Date: | July 2004 |
Study Completion Date: | February 2007 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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 (300mcg/day, changed twice a week for one year
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Drug: Testosterone (transdermal patches)
Testosterone patch (300mcg/day, changed twice a week for one year
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Detailed Description:
Hypoactive sexual desire disorder (HSDD) is a condition suffered by as many as 32% of the menopausal population. It is generally defined as a low libido which causes distress. Testosterone therapy (transdermal patch) is currently under investigation for this disorder and results of three phase 3 trials have shown evidence of efficacy in menopausal patients on hormone replacement therapy. Low libido does not discriminate between those women utilizing hormone replacement therapy and those who do not. This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy. Persons could elect to go into a single blind study for one year after completing the first yeat double blind
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Answer affirmatively to ALL of the following questions:
Exclusion Criteria:
Use of any of the following medications:
Australia, Victoria | |
Monash Medical School, The Alfred Hospital | |
Prahran, Victoria, Australia, VIC 3181 |
Principal Investigator: | Sue Davis, MD | Monash Medical School, The Alfred Hospital |
Responsible Party: | Procter and Gamble Pharmaceuticals ( Johna Lucas, MD ) |
Study ID Numbers: | 2004031 and Yr 2 SB |
Study First Received: | August 16, 2005 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00131495 |
Health Authority: | United States: Food and Drug Administration |
Low Libido Low Desire Distress |
Sexual Dysfunctions, Psychological Testosterone Mental Disorders Methyltestosterone |
Hypokinesia Menopause Testosterone 17 beta-cypionate |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Sexual and Gender Disorders Pharmacologic Actions Androgens |