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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00338312
Other study ID # 2002005 and Yr 2-4 OL
Secondary ID
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
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