Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
Information source: Procter and Gamble
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypoactive Sexual Desire Disorder
Intervention: Testosterone Transdermal System (Drug); placebo patch (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Procter and Gamble Official(s) and/or principal investigator(s):
Johna Lucas, MD, Study Director, Affiliation: Procter and Gamble
Summary
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.
Clinical Details
Official title: Study to Evaluate the Efficacy and Safety of Transdermal Testosterone in Women With Hypoactive Sexual Desire Disorder on Concurrent Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Primary outcome: To assess the efficacy of testosterone transdermal system (TS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL).
Secondary outcome: 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.
Detailed description:
Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral
salpingo-oophorectomy and hysterectomy were randomized into a 24-week, multicenter,
multinational, double-blind (DB), parallel-group, placebo-controlled study. 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. Patients who completed the first 24 weeks of the study were given the
opportunity to participate in a 3. 5 year 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 metabolism evaluation, and hematology.
Physical exam including clinical assessments of facial hair and acne were monitored.
Eligibility
Minimum age: 20 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
Eligible women must:
1. Be 20-70 years old and in generally good health
2. Have undergone hysterectomy and removal of both ovaries at least 6 months prior to
screening
3. Be receiving a stable dose of estrogen replacement therapy for at least 3 months prior
to screening with the intention of maintaining that regimen.
4. 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.
5. Meet the criteria for having hypoactive sexual desire disorder.
Exclusion Criteria:
Eligible women must not:
1. Have received androgen therapy at any time during the past 3 months (during the past 7
months if therapy was an investigational implantable product)
2. Be experiencing any chronic or acute life stress relating to any major life change
3. Be experiencing depression and/or receiving medication for such illness or disorder
4. Have current severe skin problems (such as severe or cystic acne) or allergy to
adhesives (like the ones in bandages)
5. Have had a major illness, active gall bladder disease, or gynecological or breast
surgery within the last 6 months
6. Have a history of breast, endometrial, or other gynecological cancer at any time
before study participation or other cancer within the last 5 years
7. 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
8. Have abnormal laboratory test results upon initial screening for this study
9. Have previously participated in P&GP study 1999068 or 1999092
10. Have previously participated in a clinical trial within 30 days or received an
investigation medication within 30 days.
Locations and Contacts
Research Site, Denver, Colorado, United States
Research Site, Kingston, Ontario, Canada
Research Site, Nedlands, Queensland, Australia
Additional Information
Starting date: June 2002
Ending date: July 2006
Last updated: February 6, 2008
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