Clinical trial NCT00349791: Study to Assess the Efficacy/Safety of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder (HSDD)
Keywords: Natural Menopause
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2006-07-10
Enrollment: 549
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

Eligible women must:

1. Be 40-70 years old and in generally good health
2. Be post-menopausal with no spontaneous periods for 1 year
3. Be receiving a stable dose of hormone replacement therapy for at least 3 months pror 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, thrombo-embolic 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 a clinical trial within 30 days or received an investigational medication within 30 days

Primary outcomes:
measure: 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: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Research Facility
state: Illinois
city: Randwick
country: Australia
facility: Research Facility
city: Quebec
country: Canada
facility: Research Facility
Study officials:
affiliation: Procter and Gamble
name: Johna Lucas, MD
role: STUDY_DIRECTOR
References: