Clinical trial NCT00331214: Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder
Keywords: Surgical menopause
HSDD
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2006-05-29
Enrollment: 533
Sex: FEMALE
Minimum age (years): 20
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 surgically menopausal women who are taking estrogen therapy.

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 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.

Primary outcomes:
measure: 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).
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Nedlands
country: Australia
facility: Research Site
state: Queensland
city: Kingston
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: Procter and Gamble
name: Johna Lucas, MD
role: STUDY_DIRECTOR
References: