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

Hypoactive Sexual Desire Disorder Clinical Trial

Official title:

A Study to Evaluate the Efficacy/Safety of Transdermal Testosterone for 52 Weeks and Safety for 52 Weeks in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder on Oral Hormone Replacement Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338312
• Other study ID #: 2002005 and Yr 2-4 OL
• Status: Completed
• Phase: Phase 3
• First received: June 15, 2006
• Last updated: April 15, 2013
• Start date: June 2002
• Est. completion date: July 2006

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients were stratified based on presence/absence of uterus and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen/progestin throughout the study. Patients who completed the first 52 weeks of the study were given the opportunity to participate in year 2-4 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 metabois in evaluation, coagulation testing, and hermatology. Physical exam including clinical assessments of facial hair and acne were monitored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: July 2006
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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 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 a clinical trial within 30 days or received an investigational medication within 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Testosterone Transdermal System
testosterone patch (300 mcg/day) patch changed 2 times/week, for one year
• Placebo patch
placebo patch changed twice a week for one year

Locations

Country	Name	City	State
United States	Research Facility	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		12 months	No
Secondary	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.		12 months	Yes