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

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Testosterone Transdermal System
placebo patch
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring Surgical menopause, HSDD

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Eligible women must: Be 20-70 years old and in generally good health Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening Be receiving a stable dose of estrogen 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. Exclusion Criteria: 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 P&GP study 1999068 or 1999092 Have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Placebo

Testosterone

Arm Description

placebo patch for 6 months

Testosterone patch

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
May 26, 2006
Last Updated
April 15, 2013
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT00331214
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder
Keywords
Surgical menopause, HSDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
533 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
placebo patch for 6 months
Arm Title
Testosterone
Arm Type
Experimental
Arm Description
Testosterone patch
Intervention Type
Drug
Intervention Name(s)
Testosterone Transdermal System
Intervention Description
testosterone patch (300 mcg/day), patch changed twice a week for six months
Intervention Type
Drug
Intervention Name(s)
placebo patch
Intervention Description
placebo patch replaced every 3-4 days for 6 months
Primary Outcome Measure Information:
Title
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible women must: Be 20-70 years old and in generally good health Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening Be receiving a stable dose of estrogen 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. Exclusion Criteria: 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 P&GP study 1999068 or 1999092 Have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johna Lucas, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Nedlands
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Kingston
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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

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