Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00467259
First received: April 27, 2007
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.


Condition Intervention Phase
Hypoactive Sexual Desire Disorder
Drug: Testosterone Transdermal System
Drug: Placebo patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies


Enrollment: 1271
Study Start Date: April 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
28 cm² Placebo patch
Drug: Placebo patch
placebo patch, changed twice a week for 52 weeks
Experimental: Testosterone
Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Drug: Testosterone Transdermal System
Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks

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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467259

  Hide Study Locations
Locations
United States, Alabama
Research Facility
Birmingham, Alabama, United States, 35233
Study Facility
Birmingham, Alabama, United States, 35209
Research Facility
Mobile, Alabama, United States, 36617
Research Facility
Montgomery, Alabama, United States, 36116
United States, Arizona
Test Facility
Chandler, Arizona, United States, 85225
Study Facility
Peoria, Arizona, United States, 85381
Research Facility
Phoenix, Arizona, United States, 85015
Research Facility
Phoenix, Arizona, United States, 85032
Research Facility
Scottsdale, Arizona, United States, 85251
Research Facility
Tucson, Arizona, United States, 85715
Research Site
Tucson, Arizona, United States, 85712
Study Facility
Tuscon, Arizona, United States, 85741
United States, Arkansas
Site Facility
Jonesboro, Arkansas, United States, 72401
Site Facility
Little Rock, Arkansas, United States, 72223
United States, California
Research Facility
Anaheim, California, United States, 92805
Research Site
Berkeley, California, United States, 94705
Research Facility
Palm Desert, California, United States, 92260
Research Facility
Pasadena, California, United States, 91106
Research Facility
San Diego, California, United States, 92123
Research Facility
San Ramon, California, United States, 94583
Test Facility
Santa Rosa, California, United States, 95405
Site Facility
Upland, California, United States, 91786
Site Facility
Vista, California, United States, 92083
Research Facility
Vista, California, United States, 92083
Site Facility
Westlake Village, California, United States, 91361
United States, Colorado
Test Facility
Denver, Colorado, United States, 80218
Research Facility
Longmont, Colorado, United States, 80501
United States, Connecticut
Test Facility
New London, Connecticut, United States, 06320
Study Facility
Waterbury, Connecticut, United States, 06708
United States, District of Columbia
Research Facility
Washington, District of Columbia, United States, 20036
United States, Florida
Research Facility
Boynton Beach, Florida, United States, 33437
Site Facility
Clearwater, Florida, United States, 33759
Site Facility
Daytona Beach, Florida, United States, 32114
Research Facility
Gainesville, Florida, United States, 32601
Research Site
Jacksonville, Florida, United States, 32207
Site Facility
Jupiter, Florida, United States, 33458
Test Facility
Miami, Florida, United States, 33156
Research Facility
Pinellas Park, Florida, United States, 33781
Research Facility
Plantation, Florida, United States, 33324
Study Facility
South Miami, Florida, United States, 33143
Research Site
Tampa, Florida, United States, 33606
Test Facility
Vero Beach, Florida, United States, 32960
Research Facility
West Palm Beach, Florida, United States, 33409
Research Facility
Weston, Florida, United States, 33326
United States, Georgia
Research Facility
Alpharetta, Georgia, United States, 30005
Research Facility
Atlanta, Georgia, United States, 30342
Site Facility
Decatur, Georgia, United States, 30034
Site Facility
Douglasville, Georgia, United States, 30134
Site Facility
Roswell, Georgia, United States, 30075
Test Facility
Savannah, Georgia, United States, 31405
United States, Idaho
Study Facility
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Test Facility
Champaign, Illinois, United States, 61820
Test Facility
Chicago, Illinois, United States, 60610
United States, Indiana
Test Facility
Indianapolis, Indiana, United States, 46250
United States, Kansas
Research Facility
Overland Park, Kansas, United States, 66202
United States, Kentucky
Site Facility
Louisville, Kentucky, United States, 40291
United States, Maryland
Research Facility
Baltimore, Maryland, United States, 21285-6815
Study Facility
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Study Facility
Boston, Massachusetts, United States, 02114
United States, Michigan
Research Facility
Bingham Farm, Michigan, United States, 48025
Study Facility
Paw Paw, Michigan, United States, 49079
Test Facility
Saginaw, Michigan, United States
United States, Minnesota
Research Facility
Edina, Minnesota, United States, 55435
United States, Mississippi
Research Site
Jackson, Mississippi, United States, 39216
United States, Missouri
Test Facility
St Louis, Missouri, United States, 63141
United States, Montana
Site Facility
Billings, Montana, United States, 59102
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68124
United States, Nevada
Site Facility
Las Vegas, Nevada, United States, 89146
Test Facility
Reno, Nevada, United States, 89502
United States, New Jersey
Test Facility
Moorestown, New Jersey, United States, 08057
United States, New York
Research Facility
New York, New York, United States, 10016
United States, North Carolina
Test Facility
Raleigh, North Carolina, United States, 27609
Study Facility
Winston Salem, North Carolina, United States, 27103
Site Facility
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Research Facility
Beachwood, Ohio, United States, 44122
Test Facility
Centerville, Ohio, United States, 45459
Research Facility
Cincinnati, Ohio, United States, 45267-0457
Research Facility
Cincinnati, Ohio, United States, 45219
Study Facility
Cincinnati, Ohio, United States, 45249
Site Facility
Cleveland, Ohio, United States, 44122
Research Site
Cleveland, Ohio, United States, 44106
Test Facility
Columbus, Ohio, United States, 43212
Test Facility
Columbus, Ohio, United States, 43231
Research Facility
Dayton, Ohio, United States, 45409
Test Facility
Englewood, Ohio, United States, 45322
United States, Oklahoma
Test Facility
Oklahoma City, Oklahoma, United States
Test Facility
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Site Facility
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Research Facility
Philadelphia, Pennsylvania, United States, 19114
United States, Tennessee
Study Facility
Bristol, Tennessee, United States, 37620
Research Facility
Chattanooga, Tennessee, United States, 37404
Research Facility
Nashville, Tennessee, United States, 37203
United States, Texas
Site Facility
Austin, Texas, United States, 78705
Research Facility
Carrolton, Texas, United States, 75007
Site Facility
Corpus Christi, Texas, United States, 78414
Research Facility
Dallas, Texas, United States, 75231
Test Facility
Farmers Branch, Texas, United States, 75234
Research Facility
Houston, Texas, United States, 77030
Research Facility
Irving, Texas, United States, 75061
Research Facility
Midland, Texas, United States, 79705
Research Facility
Richardson, Texas, United States, 75082
Site Facility
San Antonio, Texas, United States, 78229
Test Facility
San Antonio, Texas, United States, 78229
United States, Utah
Study Facility
Salt Lake City, Utah, United States, 84117
Research Facility
West Valley City, Utah, United States, 84120
United States, Virginia
Research Facility
Newport News, Virginia, United States, 23606
Study Facility
Richmond, Virginia, United States, 23229
Site Facility
Richmond, Virginia, United States, 23294
Test Facility
Richmond, Virginia, United States, 23229
Research Facility
Virginia Beach, Virginia, United States, 23452
Research Facility
Virginia Beach, Virginia, United States, 23456
United States, Washington
Site Facility
Seattle, Washington, United States, 98105
Research Facility
Tacoma, Washington, United States, 98405
Test Facility
Tacoma, Washington, United States, 98405
United States, West Virginia
Research Site
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Johna Lucas, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00467259     History of Changes
Other Study ID Numbers: 2007004
Study First Received: April 27, 2007
Results First Received: August 3, 2011
Last Updated: November 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
Natural Menopause

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Hypokinesia
Sexual and Gender Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on July 23, 2014