CompletedPhase 3

Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido

United States610 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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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 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

✕. 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, 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

What they're measuring

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).

Timeframe: 12 months

Trial details

NCT IDNCT00338312

SponsorWarner Chilcott

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-12

View on ClinicalTrials.gov More Hypoactive Sexual Desire Disorder trials