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

NCT00467259 | Completed Phase 3 Results DMC

• 1 other identifier: 2007004
• Study Type: interventional
• Target: 1,271
• Locations: 1 country
• Sites: 115

Brief Summary

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

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Natural Menopause

Outcome Measures

Primary Outcomes (1)

• 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

  52 weeks

Secondary Outcomes (2)

• Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1

  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

  52 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

28 cm² Placebo patch

Drug: Placebo patch

Testosterone

EXPERIMENTAL

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

Drug: Testosterone Transdermal System

Interventions

Testosterone Transdermal System DRUG

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

Testosterone

Placebo patch DRUG

placebo patch, changed twice a week for 52 weeks

Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Warner Chilcott: lead

Study Sites (115)

Study Facility

Birmingham, Alabama, 35209, United States

Location

Research Facility

Birmingham, Alabama, 35233, United States

Location

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Mobile, Alabama, 36617, United States

Location

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Montgomery, Alabama, 36116, United States

Location

Test Facility

Chandler, Arizona, 85225, United States

Location

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Peoria, Arizona, 85381, United States

Location

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Phoenix, Arizona, 85015, United States

Location

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Phoenix, Arizona, 85032, United States

Location

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Scottsdale, Arizona, 85251, United States

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Tucson, Arizona, 85712, United States

Location

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Tucson, Arizona, 85715, United States

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Tuscon, Arizona, 85741, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72223, United States

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Anaheim, California, 92805, United States

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Berkeley, California, 94705, United States

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Palm Desert, California, 92260, United States

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Pasadena, California, 91106, United States

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San Diego, California, 92123, United States

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San Ramon, California, 94583, United States

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Santa Rosa, California, 95405, United States

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Upland, California, 91786, United States

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Vista, California, 92083, United States

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Vista, California, 92083, United States

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Westlake Village, California, 91361, United States

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Denver, Colorado, 80218, United States

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Longmont, Colorado, 80501, United States

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New London, Connecticut, 06320, United States

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Waterbury, Connecticut, 06708, United States

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Washington D.C., District of Columbia, 20036, United States

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Boynton Beach, Florida, 33437, United States

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Clearwater, Florida, 33759, United States

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Daytona Beach, Florida, 32114, United States

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Gainesville, Florida, 32601, United States

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Jacksonville, Florida, 32207, United States

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Jupiter, Florida, 33458, United States

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Miami, Florida, 33156, United States

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Pinellas Park, Florida, 33781, United States

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Plantation, Florida, 33324, United States

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South Miami, Florida, 33143, United States

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Tampa, Florida, 33606, United States

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Vero Beach, Florida, 32960, United States

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West Palm Beach, Florida, 33409, United States

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Weston, Florida, 33326, United States

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Alpharetta, Georgia, 30005, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30034, United States

Location

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Douglasville, Georgia, 30134, United States

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Roswell, Georgia, 30075, United States

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Savannah, Georgia, 31405, United States

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Idaho Falls, Idaho, 83404, United States

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Champaign, Illinois, 61820, United States

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Chicago, Illinois, 60610, United States

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Indianapolis, Indiana, 46250, United States

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Overland Park, Kansas, 66202, United States

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Louisville, Kentucky, 40291, United States

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Baltimore, Maryland, 21229, United States

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Baltimore, Maryland, 21285-6815, United States

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Boston, Massachusetts, 02114, United States

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Bingham Farm, Michigan, 48025, United States

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Paw Paw, Michigan, 49079, United States

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Saginaw, Michigan, United States

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Edina, Minnesota, 55435, United States

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Jackson, Mississippi, 39216, United States

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St Louis, Missouri, 63141, United States

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Billings, Montana, 59102, United States

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Omaha, Nebraska, 68124, United States

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Las Vegas, Nevada, 89146, United States

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Reno, Nevada, 89502, United States

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Moorestown, New Jersey, 08057, United States

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New York, New York, 10016, United States

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Raleigh, North Carolina, 27609, United States

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Winston-Salem, North Carolina, 27103, United States

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Winston-Salem, North Carolina, 27103, United States

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Beachwood, Ohio, 44122, United States

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Centerville, Ohio, 45459, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45249, United States

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Cincinnati, Ohio, 45267-0457, United States

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Cleveland, Ohio, 44106, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43212, United States

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Columbus, Ohio, 43231, United States

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Dayton, Ohio, 45409, United States

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Englewood, Ohio, 45322, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, 74104, United States

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Eugene, Oregon, 97401, United States

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Philadelphia, Pennsylvania, 19114, United States

Location

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Bristol, Tennessee, 37620, United States

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Chattanooga, Tennessee, 37404, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78705, United States

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Carrolton, Texas, 75007, United States

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Site Facility

Corpus Christi, Texas, 78414, United States

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Dallas, Texas, 75231, United States

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Farmers Branch, Texas, 75234, United States

Location

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Houston, Texas, 77030, United States

Location

Research Facility

Irving, Texas, 75061, United States

Location

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Midland, Texas, 79705, United States

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Richardson, Texas, 75082, United States

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Site Facility

San Antonio, Texas, 78229, United States

Location

Test Facility

San Antonio, Texas, 78229, United States

Location

Study Facility

Salt Lake City, Utah, 84117, United States

Location

Research Facility

West Valley City, Utah, 84120, United States

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Newport News, Virginia, 23606, United States

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Study Facility

Richmond, Virginia, 23229, United States

Location

Test Facility

Richmond, Virginia, 23229, United States

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Site Facility

Richmond, Virginia, 23294, United States

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Virginia Beach, Virginia, 23452, United States

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Research Facility

Virginia Beach, Virginia, 23456, United States

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Site Facility

Seattle, Washington, 98105, United States

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Tacoma, Washington, 98405, United States

Location

Test Facility

Tacoma, Washington, 98405, United States

Location

Research Site

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Grexan Wulff, Manager Regulatory Affairs
• Organization: Warner Chilcott

gwulff@wcrx.com

973-442-3376

Study Officials

• Johna Lucas, MD

  Procter and Gamble

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: April 30, 2007
• Study Start: April 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 15, 2011
• Results First Posted: December 15, 2011

Record last verified: 2011-11

Locations

US (115)