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

• ClinicalTrials.gov Identifier: NCT00331123
• Recruitment Status: Completed
• First Posted: May 29, 2006
• Last Update Posted: April 17, 2013
• Sponsor: Warner Chilcott
• Information provided by (Responsible Party): Warner Chilcott

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypoactive Sexual Desire Disorder	Drug: Testosterone Transdermal System; Drug: Placebo	Phase 3

Detailed Description:

Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 52-week, multicenter, multinational study that included a 24-week, double-blind (DB), parallel-group, placebo-controlled period followed by a 28-week open-label (OL) period. 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. Upon completion of the DB period, patients receiving placebo were switched to TTS, while the active cohort remained on active treatment. All patients were then followed for an additional 28 weeks for safety. Patients who completed the first 52 weeks of the study were given the opportunity to participate in an open label extension (Years 2, 3 , and 4), which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, coagulation testing, and hematology. Physical exam including clinical assessments of facial hair and acne were monitored.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 562 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Study to Evaluate Efficacy and Safety of Transdermal Testosterone and Safety for an Open-label Period in Women With Hypoactive Sexual Desire Disorder on Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy.
• Study Start Date: May 2002
• Actual Primary Completion Date: December 2003
• Actual Study Completion Date: July 2006

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo patch	Drug: Placebo; placebo patch,changed every 3-4 days for 24 weeks during double blind phase
Experimental: Testosterone Patch	Drug: Testosterone Transdermal System; testosterone patch, 300mcg/day, changed every 3-4 days for up to 52 weeks

Outcome Measures

Primary Outcome Measures :

1. To assess the efficacy of testosterone 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). [ Time Frame: 24 weeks ]

Secondary Outcome Measures :

1. 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. [ Time Frame: 24 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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 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.

Contacts and Locations

Locations

United States, Missouri

Research Site

Kansas City, Missouri, United States

Australia, Victoria

Research Site

Prahran, Victoria, Australia

Canada

Research Site

Quebec, Canada

Sponsors and Collaborators

Warner Chilcott

Investigators

• Study Director: Johna Lucus, MD; Procter and Gamble

More Information

• Responsible Party: Warner Chilcott
• ClinicalTrials.gov Identifier: NCT00331123
• Other Study ID Numbers: 2001133 and Yr 2-4 OL
• First Posted: May 29, 2006
• Last Update Posted: April 17, 2013
• Last Verified: April 2013

Keywords provided by Warner Chilcott:

Surgical menopause; HSDD

Additional relevant MeSH terms:

Hypokinesia; Sexual Dysfunctions, Psychological; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Testosterone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs