- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00331123
Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
April 15, 2013 updated by: Warner Chilcott
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
562
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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Victoria
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Prahran, Victoria, Australia
- Research Site
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Quebec, Canada
- Research Site
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Missouri
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Kansas City, Missouri, United States
- Research Site
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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
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Eligible women must:
- Be 20-70 years old and in generally good health
- Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening
- Be receiving a stable dose of estrogen replacement therapy for at least 3 months prior 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 any time before study participation or other cancer within the last 5 years
- Have diabetes, a history of cerebrovascular disease, thromboembolic 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 P&GP study 1999068 or 1999092
- Have previously participated in a clinical trial within 30 days or received an investigation 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 |
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Placebo Comparator: Placebo
Placebo patch
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placebo patch,changed every 3-4 days for 24 weeks during double blind phase
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Experimental: Testosterone Patch
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testosterone patch, 300mcg/day, changed every 3-4 days for up to 52 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the efficacy of testosterone 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: 24 weeks
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the efficacy measured by the change from baseline in sexual desire; personal distress as measured by the Personal Distress Scale score; the other 6 domains of the profile of Female Sexual Function; and the other 8 SAL endpoints.
Time Frame: 24 weeks
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Johna Lucus, MD, Procter and Gamble
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
May 1, 2002
Primary Completion (Actual)
December 1, 2003
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
May 26, 2006
First Submitted That Met QC Criteria
May 26, 2006
First Posted (Estimate)
May 29, 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
- 2001133 and Yr 2-4 OL
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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