Back to resultsEndometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
Primary Purpose
Hypoactive Sexual Desire Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Testosterone Transdermal System
Placebo patch
Sponsored by
About this trial
This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring Natural Menopause
Eligibility Criteria
Inclusion Criteria:
- Women will be screened for study participation and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress.
Exclusion Criteria:
- Women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.
Sites / Locations
- Study Facility
- Research Facility
- Research Facility
- Research Facility
- Test Facility
- Study Facility
- Research Facility
- Research Facility
- Research Facility
- Research Site
- Research Facility
- Study Facility
- Site Facility
- Site Facility
- Research Facility
- Research Site
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Test Facility
- Site Facility
- Research Facility
- Site Facility
- Site Facility
- Test Facility
- Research Facility
- Test Facility
- Study Facility
- Research Facility
- Research Facility
- Site Facility
- Site Facility
- Research Facility
- Research Site
- Site Facility
- Test Facility
- Research Facility
- Research Facility
- Study Facility
- Research Site
- Test Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Site Facility
- Site Facility
- Site Facility
- Test Facility
- Study Facility
- Test Facility
- Test Facility
- Test Facility
- Research Facility
- Site Facility
- Study Facility
- Research Facility
- Study Facility
- Research Facility
- Study Facility
- Test Facility
- Research Facility
- Research Site
- Test Facility
- Site Facility
- Research Site
- Site Facility
- Test Facility
- Test Facility
- Research Facility
- Test Facility
- Study Facility
- Site Facility
- Research Facility
- Test Facility
- Research Facility
- Study Facility
- Research Facility
- Research Site
- Site Facility
- Test Facility
- Test Facility
- Research Facility
- Test Facility
- Test Facility
- Test Facility
- Site Facility
- Research Facility
- Study Facility
- Research Facility
- Research Facility
- Site Facility
- Research Facility
- Site Facility
- Research Facility
- Test Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Site Facility
- Test Facility
- Study Facility
- Research Facility
- Research Facility
- Study Facility
- Test Facility
- Site Facility
- Research Facility
- Research Facility
- Site Facility
- Research Facility
- Test Facility
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Testosterone
Arm Description
28 cm² Placebo patch
Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Outcomes
Primary Outcome Measures
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
Secondary Outcome Measures
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00467259
Brief Title
Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
Official Title
A Randomized, Double-Blind, Placebo-controlled, Multicenter, 52-week Study to Evaluate the Endometrial Safety of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.
Detailed Description
Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients will be stratified based on whether they use concomitant estrogen/progestin therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system (300 mcg/day) or placebo. Patients using estrogen/progestin at the start of the study should maintain this therapy throughout the study; patients not using estrogen/progestin at the start of the study should not initiate estrogen/progestin therapy throughout the study. Endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening and study exit for all patients. Safety will be assessed by adverse events, reports of vaginal bleeding, lipids, serum chemistry, and hematology. Physical exams, pap smears, and mammograms will be 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
Natural Menopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1271 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
28 cm² Placebo patch
Arm Title
Testosterone
Arm Type
Experimental
Arm Description
Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Testosterone Transdermal System
Intervention Description
Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo patch
Intervention Description
placebo patch, changed twice a week for 52 weeks
Primary Outcome Measure Information:
Title
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1
Description
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1
Description
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
Time Frame
52 weeks
Title
Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1
Description
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
Time Frame
52 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women will be screened for study participation and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress.
Exclusion Criteria:
Women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.
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
Study Facility
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Research Facility
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Research Facility
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Research Facility
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Test Facility
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Study Facility
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Research Facility
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Research Facility
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Research Facility
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Research Facility
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Study Facility
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Site Facility
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Site Facility
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72223
Country
United States
Facility Name
Research Facility
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Research Site
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Research Facility
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Research Facility
City
Pasadena
State/Province
California
ZIP/Postal Code
91106
Country
United States
Facility Name
Research Facility
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Research Facility
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Test Facility
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Site Facility
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Research Facility
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Site Facility
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Site Facility
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Test Facility
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Research Facility
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Test Facility
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Study Facility
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Research Facility
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Research Facility
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Site Facility
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Site Facility
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Research Facility
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32601
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Site Facility
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Test Facility
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Research Facility
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Research Facility
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Study Facility
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Test Facility
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Research Facility
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Research Facility
City
Weston
State/Province
Florida
ZIP/Postal Code
33326
Country
United States
Facility Name
Research Facility
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Research Facility
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Site Facility
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Site Facility
City
Douglasville
State/Province
Georgia
ZIP/Postal Code
30134
Country
United States
Facility Name
Site Facility
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Test Facility
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Study Facility
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Test Facility
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Test Facility
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Test Facility
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Research Facility
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Site Facility
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Study Facility
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Research Facility
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285-6815
Country
United States
Facility Name
Study Facility
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Research Facility
City
Bingham Farm
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Study Facility
City
Paw Paw
State/Province
Michigan
ZIP/Postal Code
49079
Country
United States
Facility Name
Test Facility
City
Saginaw
State/Province
Michigan
Country
United States
Facility Name
Research Facility
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Test Facility
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Site Facility
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Site Facility
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Test Facility
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Test Facility
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Research Facility
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Test Facility
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Study Facility
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site Facility
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Facility
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Test Facility
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Research Facility
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Study Facility
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Research Facility
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0457
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Site Facility
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Test Facility
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Test Facility
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
Facility Name
Research Facility
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Test Facility
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Test Facility
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Test Facility
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Site Facility
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Research Facility
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Study Facility
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Research Facility
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Research Facility
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Site Facility
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Research Facility
City
Carrolton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Site Facility
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Research Facility
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Test Facility
City
Farmers Branch
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Research Facility
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Facility
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Research Facility
City
Midland
State/Province
Texas
ZIP/Postal Code
79705
Country
United States
Facility Name
Research Facility
City
Richardson
State/Province
Texas
ZIP/Postal Code
75082
Country
United States
Facility Name
Site Facility
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Test Facility
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Study Facility
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Research Facility
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
Research Facility
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Study Facility
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Test Facility
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Site Facility
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Research Facility
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
Research Facility
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Site Facility
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Research Facility
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Test Facility
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
We'll reach out to this number within 24 hrs