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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1271

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings