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Tracking Information | |||||
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First Received Date † | August 16, 2005 | ||||
Last Updated Date | February 6, 2008 | ||||
Start Date † | July 2004 | ||||
Current Primary Outcome Measures † |
Total satisfying sexual activity over 24 weeks [ Time Frame: 6, 12, 24, 36, and 52 weeks ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00131495 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido | ||||
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 | ||||
Brief Summary | 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. |
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Detailed Description | 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 |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Hypoactive Sexual Desire Disorder | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | Davis SR, Moreau M, Kroll R, Bouchard C, Panay N, Gass M, Braunstein GD, Hirschberg AL, Rodenberg C, Pack S, Koch H, Moufarege A, Studd J; APHRODITE Study Team. Testosterone for low libido in postmenopausal women not taking estrogen. N Engl J Med. 2008 Nov 6;359(19):2005-17. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 814 | ||||
Completion Date | February 2007 | ||||
Primary Completion Date | February 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 20 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Australia | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00131495 | ||||
Responsible Party | Johna Lucas, MD, Procter and Gamble Pharmaceuticals | ||||
Secondary IDs †† | |||||
Study Sponsor † | Procter and Gamble | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Procter and Gamble | ||||
Verification Date | February 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |