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

November 10, 2011 updated by: Warner Chilcott

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1271

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1
Time Frame: 52 weeks
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
52 weeks
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
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

April 27, 2007

First Submitted That Met QC Criteria

April 27, 2007

First Posted (ESTIMATE)

April 30, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 15, 2011

Last Update Submitted That Met QC Criteria

November 10, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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