Study to Assess the Efficacy/Safety of Transdermal Testosterone Patches in Naturally Menopausal W… (NCT00349791) | Clinical Trial Compass
CompletedPhase 3
Study to Assess the Efficacy/Safety of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido
United States, Australia, Canada549 participantsStarted 2002-06
Plain-language summary
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.
Who can participate
Age range40 Years – 70 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✕. 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
What they're measuring
1
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).
. 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