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

NCT00338312 | Completed Phase 3

• 1 other identifier: 2002005 and Yr 2-4 OL
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Natural Menopause; HSDD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo patch

Drug: Placebo patch

2

EXPERIMENTAL

testosterone patch (300 mcg/day) patch changed 2 times/week, for one year

Drug: Testosterone Transdermal System

Interventions

Testosterone Transdermal System DRUG

testosterone patch (300 mcg/day) patch changed 2 times/week, for one year

2

Placebo patch DRUG

placebo patch changed twice a week for one year

1

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible women must:
• 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

You may not qualify if:

• Eligible women must not:
• 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
• Have previously participated in a clinical trial within 30 days or received an investigational medication within 30 days

Sponsors & Collaborators

• Warner Chilcott: lead

Study Sites (1)

Research Facility

Denver, Colorado, 80202, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Johna Lucas, MD

  Procter and Gamble

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2006
• First Posted: June 20, 2006
• Study Start: June 1, 2002
• Primary Completion: December 1, 2004
• Study Completion: July 1, 2006
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

US (1)