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

NCT ID: NCT00467259

Last Updated: 2011-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypoactive Sexual Desire Disorder

Keywords

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Natural Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

28 cm² Placebo patch

Group Type PLACEBO_COMPARATOR

Placebo patch

Intervention Type DRUG

placebo patch, changed twice a week for 52 weeks

Testosterone

Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks

Group Type EXPERIMENTAL

Testosterone Transdermal System

Intervention Type DRUG

Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks

Interventions

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Testosterone Transdermal System

Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks

Intervention Type DRUG

Placebo patch

placebo patch, changed twice a week for 52 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johna Lucas, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

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Study Facility

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Montgomery, Alabama, United States

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Chandler, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Tuscon, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Berkeley, California, United States

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Palm Desert, California, United States

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Pasadena, California, United States

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San Diego, California, United States

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San Ramon, California, United States

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Santa Rosa, California, United States

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Upland, California, United States

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Vista, California, United States

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Vista, California, United States

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Westlake Village, California, United States

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Denver, Colorado, United States

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Longmont, Colorado, United States

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New London, Connecticut, United States

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Waterbury, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Miami, Florida, United States

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Pinellas Park, Florida, United States

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Plantation, Florida, United States

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South Miami, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

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Weston, Florida, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Douglasville, Georgia, United States

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Roswell, Georgia, United States

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Savannah, Georgia, United States

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Idaho Falls, Idaho, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Bingham Farm, Michigan, United States

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Paw Paw, Michigan, United States

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Saginaw, Michigan, United States

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Edina, Minnesota, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Moorestown, New Jersey, United States

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New York, New York, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Beachwood, Ohio, United States

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Centerville, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Englewood, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Carrolton, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Farmers Branch, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Midland, Texas, United States

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Richardson, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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West Valley City, Utah, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Tacoma, Washington, United States

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Charleston, West Virginia, United States

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Countries

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United States

Other Identifiers

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2007004

Identifier Type: -

Identifier Source: org_study_id