- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00349791
Study to Assess the Efficacy/Safety of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido
April 15, 2013 updated by: Warner Chilcott
A Study to Evaluate the Efficacy/Safety of Transdermal Testosterone for 24 Weeks in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder on Oral Hormone Replacement Therapy.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 24-week, multicenter, multinational, double-blind (DB), parallel-group, placebo-controlled study.
Patients were randomized to receive a placebo or testosterone transdermal system throughout the study.
Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, and hematology.
Physical exam including clinical assessments of facial hair and acne were monitored.
Study Type
Interventional
Enrollment (Actual)
549
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Randwick, Australia
- Research Facility
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Quebec, Canada
- Research Facility
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Illinois
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Chicago, Illinois, United States
- Research Facility
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Eligible women must:
- Be 40-70 years old and in generally good health
- Be post-menopausal with no spontaneous periods for 1 year
- Be receiving a stable dose of hormone replacement therapy for at least 3 months pror to screening with the intention of maintaining that regimen.
- Be, in her own judgment, in a stable, monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry
- Meet the criteria for having hypoactive sexual desire disorder
Exclusion Criteria:
Eligible women must not:
- Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
- Be experiencing any chronic or acute life stress relating to any major life change
- Be experiencing depression and/or receiving medication for such illness or disorder
- Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
- Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
- Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years
- Have diabetes, a history of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years
- Have abnormal laboratory test results upon initial screening for this study
- Have previously participated in a clinical trial within 30 days or received an investigational medication within 30 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
placebo patch replaced twice a week for two years
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placebo patch replaced twice a week for two years
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Experimental: 2
testosterone patch replaced twice a week for two years
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testosterone (300 mcg/day) patch replaced twice a week for two years
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the efficacy of the transdermal system (TTS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL).
Time Frame: 2 years
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the efficacy measured by the change from baseline in sexual desire using personal distress as measured by the Personal Distress Scale (PDS) score; the other 6 domains of the Profile of Female Sexual function, and the other 8 SAL endpoints.
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Primary Completion (Actual)
October 1, 2003
Study Completion (Actual)
October 1, 2003
Study Registration Dates
First Submitted
July 7, 2006
First Submitted That Met QC Criteria
July 7, 2006
First Posted (Estimate)
July 10, 2006
Study Record Updates
Last Update Posted (Estimate)
April 17, 2013
Last Update Submitted That Met QC Criteria
April 15, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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