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Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Testosterone (transdermal patches)
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 Low Libido, Low Desire, Distress

Eligibility Criteria

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

Inclusion Criteria: Be a generally healthy surgically menopausal woman (12 months), 20 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy Be a generally healthy naturally menopausal woman (2 years since last period), 40 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy. Be, in their own judgment, in a stable monogamous sexual relationship for at least one year prior to study entry that is perceived to be secure and communicative with the same partner who is sexually functional and physically present at least 50% of the time. Answer affirmatively to ALL of the following questions: Was the patient's sex life before menopause good and satisfying in general? Since menopause, has a meaningful loss in the level of desire for sex occurred? Since menopause, has a significant decrease in sexual activity occurred? Is the current level of desire for or interest in sex bothering or concerning? Is an increase in the level of interest in or desire for sex and sexual activity desired? Exclusion Criteria: Physical limitations that would interfere with normal sexual function; Estrogen use in the last 12 weeks (vaginal estriol or low dose vaginal estradiol accepted) Use of any of the following medications: antiandrogen therapy or topical minoxidil (last 5 years), androgen therapy (past 3 months/implantable past 7 months), systemic corticosteroids, selective serotonin reuptake inhibitors (SSRIs), tricyclic anti-depressants, anti-androgens, systemic beta-blockers, anti-adrenergics, spironolactone, apomorphine, phosphodiesterase type 5 (PDE5) inhibitors (e.g., Viagra, tibolone or selective estrogen receptor modulators (SERMs), including tamoxifen (last 12 weeks)) Be experiencing any chronic or acute life stress relating to any major life change that may significantly interfere with sexual function; Have significant psychiatric disorder (including mild depressive disorder - Beck Depression Inventory-II score of > 14; Have current severe dermatological problems or a known suspected hypersensitivity or allergy to any adhesive or any of the constituents of the transdermal testosterone patch Have evidence of or history of malignancy (estrogen dependent or any gynecological cancer) within the last 5 years; Have diabetes mellitus, active gallbladder disease, unstable thyroid disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina within the last 5 years or other significant organic disease that would prevent the patient from completing the study, or otherwise affect the outcome of the study. Have significant abnormal pretreatment laboratory parameters.

Sites / Locations

  • Monash Medical School, The Alfred Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Placebo patch

Testosterone patch (300mcg/day, changed twice a week for one year

Outcomes

Primary Outcome Measures

Total satisfying sexual activity over 24 weeks

Secondary Outcome Measures

Sexual desire
personal distress
other domains of the Profile of Female Sexual Function over 24 weeks
mood, energy and well-being
menopausal symptoms

Full Information

First Posted
August 16, 2005
Last Updated
April 15, 2013
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT00131495
Brief Title
Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido
Official Title
A Randomized, Double-Blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy/Safety of Transdermal Patches Delivering Testosterone in Menopausal Women With Low Libido Not Receiving Estrogen Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2007 (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 the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy.
Detailed Description
Detailed Description: Hypoactive sexual desire disorder (HSDD) is a condition suffered by as many as 32% of the menopausal population. It is generally defined as a low libido which causes distress. Testosterone therapy (transdermal patch) is currently under investigation for this disorder and results of three phase 3 trials have shown evidence of efficacy in menopausal patients on hormone replacement therapy. Low libido does not discriminate between those women utilizing hormone replacement therapy and those who do not. This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy. Persons could elect to go into a single blind study for one year after completing the first yeat double blind

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder
Keywords
Low Libido, Low Desire, Distress

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo patch
Arm Title
2
Arm Type
Experimental
Arm Description
Testosterone patch (300mcg/day, changed twice a week for one year
Intervention Type
Drug
Intervention Name(s)
Testosterone (transdermal patches)
Intervention Description
Testosterone patch (300mcg/day, changed twice a week for one year
Intervention Type
Drug
Intervention Name(s)
Placebo patch
Intervention Description
placebo patch changed twice a week for one year
Primary Outcome Measure Information:
Title
Total satisfying sexual activity over 24 weeks
Time Frame
6, 12, 24, 36, and 52 weeks
Secondary Outcome Measure Information:
Title
Sexual desire
Time Frame
6, 12, 24, 36, and 52 weeks
Title
personal distress
Time Frame
6, 12, 24, 36, and 52 weeks
Title
other domains of the Profile of Female Sexual Function over 24 weeks
Time Frame
6, 12, 24, 36, and 52 weeks
Title
mood, energy and well-being
Time Frame
6, 12, 24, 36, and 52 weeks
Title
menopausal symptoms
Time Frame
6, 12, 24, 36, and 52 weeks

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: Be a generally healthy surgically menopausal woman (12 months), 20 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy Be a generally healthy naturally menopausal woman (2 years since last period), 40 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy. Be, in their own judgment, in a stable monogamous sexual relationship for at least one year prior to study entry that is perceived to be secure and communicative with the same partner who is sexually functional and physically present at least 50% of the time. Answer affirmatively to ALL of the following questions: Was the patient's sex life before menopause good and satisfying in general? Since menopause, has a meaningful loss in the level of desire for sex occurred? Since menopause, has a significant decrease in sexual activity occurred? Is the current level of desire for or interest in sex bothering or concerning? Is an increase in the level of interest in or desire for sex and sexual activity desired? Exclusion Criteria: Physical limitations that would interfere with normal sexual function; Estrogen use in the last 12 weeks (vaginal estriol or low dose vaginal estradiol accepted) Use of any of the following medications: antiandrogen therapy or topical minoxidil (last 5 years), androgen therapy (past 3 months/implantable past 7 months), systemic corticosteroids, selective serotonin reuptake inhibitors (SSRIs), tricyclic anti-depressants, anti-androgens, systemic beta-blockers, anti-adrenergics, spironolactone, apomorphine, phosphodiesterase type 5 (PDE5) inhibitors (e.g., Viagra, tibolone or selective estrogen receptor modulators (SERMs), including tamoxifen (last 12 weeks)) Be experiencing any chronic or acute life stress relating to any major life change that may significantly interfere with sexual function; Have significant psychiatric disorder (including mild depressive disorder - Beck Depression Inventory-II score of > 14; Have current severe dermatological problems or a known suspected hypersensitivity or allergy to any adhesive or any of the constituents of the transdermal testosterone patch Have evidence of or history of malignancy (estrogen dependent or any gynecological cancer) within the last 5 years; Have diabetes mellitus, active gallbladder disease, unstable thyroid disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina within the last 5 years or other significant organic disease that would prevent the patient from completing the study, or otherwise affect the outcome of the study. Have significant abnormal pretreatment laboratory parameters.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Davis, MD
Organizational Affiliation
Monash Medical School, The Alfred Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monash Medical School, The Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
VIC 3181
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
18987368
Citation
Davis SR, Moreau M, Kroll R, Bouchard C, Panay N, Gass M, Braunstein GD, Hirschberg AL, Rodenberg C, Pack S, Koch H, Moufarege A, Studd J; APHRODITE Study Team. Testosterone for low libido in postmenopausal women not taking estrogen. N Engl J Med. 2008 Nov 6;359(19):2005-17. doi: 10.1056/NEJMoa0707302.
Results Reference
derived

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Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido

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