Clinical trial NCT00467259: Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder
Keywords: Natural Menopause
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2007-04-30
Enrollment: 1271
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1
timeFrame: 52 weeks
Secondary outcomes:
measure: Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1
timeFrame: 52 weeks
measure: Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Study Facility
state: Alabama
city: Birmingham
country: United States
facility: Research Facility
state: Alabama
city: Mobile
country: United States
facility: Research Facility
state: Alabama
city: Montgomery
country: United States
facility: Research Facility
state: Alabama
city: Chandler
country: United States
facility: Test Facility
state: Arizona
city: Peoria
country: United States
facility: Study Facility
state: Arizona
city: Phoenix
country: United States
facility: Research Facility
state: Arizona
city: Phoenix
country: United States
facility: Research Facility
state: Arizona
city: Scottsdale
country: United States
facility: Research Facility
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Facility
state: Arizona
city: Tuscon
country: United States
facility: Study Facility
state: Arizona
city: Jonesboro
country: United States
facility: Site Facility
state: Arkansas
city: Little Rock
country: United States
facility: Site Facility
state: Arkansas
city: Anaheim
country: United States
facility: Research Facility
state: California
city: Berkeley
country: United States
facility: Research Site
state: California
city: Palm Desert
country: United States
facility: Research Facility
state: California
city: Pasadena
country: United States
facility: Research Facility
state: California
city: San Diego
country: United States
facility: Research Facility
state: California
city: San Ramon
country: United States
facility: Research Facility
state: California
city: Santa Rosa
country: United States
facility: Test Facility
state: California
city: Upland
country: United States
facility: Site Facility
state: California
city: Vista
country: United States
facility: Research Facility
state: California
city: Vista
country: United States
facility: Site Facility
state: California
city: Westlake Village
country: United States
facility: Site Facility
state: California
city: Denver
country: United States
facility: Test Facility
state: Colorado
city: Longmont
country: United States
facility: Research Facility
state: Colorado
city: New London
country: United States
facility: Test Facility
state: Connecticut
city: Waterbury
country: United States
facility: Study Facility
state: Connecticut
city: Washington
country: United States
facility: Research Facility
state: District of Columbia
city: Boynton Beach
country: United States
facility: Research Facility
state: Florida
city: Clearwater
country: United States
facility: Site Facility
state: Florida
city: Daytona Beach
country: United States
facility: Site Facility
state: Florida
city: Gainesville
country: United States
facility: Research Facility
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Jupiter
country: United States
facility: Site Facility
state: Florida
city: Miami
country: United States
facility: Test Facility
state: Florida
city: Pinellas Park
country: United States
facility: Research Facility
state: Florida
city: Plantation
country: United States
facility: Research Facility
state: Florida
city: South Miami
country: United States
facility: Study Facility
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Vero Beach
country: United States
facility: Test Facility
state: Florida
city: West Palm Beach
country: United States
facility: Research Facility
state: Florida
city: Weston
country: United States
facility: Research Facility
state: Florida
city: Alpharetta
country: United States
facility: Research Facility
state: Georgia
city: Atlanta
country: United States
facility: Research Facility
state: Georgia
city: Decatur
country: United States
facility: Site Facility
state: Georgia
city: Douglasville
country: United States
facility: Site Facility
state: Georgia
city: Roswell
country: United States
facility: Site Facility
state: Georgia
city: Savannah
country: United States
facility: Test Facility
state: Georgia
city: Idaho Falls
country: United States
facility: Study Facility
state: Idaho
city: Champaign
country: United States
facility: Test Facility
state: Illinois
city: Chicago
country: United States
facility: Test Facility
state: Illinois
city: Indianapolis
country: United States
facility: Test Facility
state: Indiana
city: Overland Park
country: United States
facility: Research Facility
state: Kansas
city: Louisville
country: United States
facility: Site Facility
state: Kentucky
city: Baltimore
country: United States
facility: Study Facility
state: Maryland
city: Baltimore
country: United States
facility: Research Facility
state: Maryland
city: Boston
country: United States
facility: Study Facility
state: Massachusetts
city: Bingham Farm
country: United States
facility: Research Facility
state: Michigan
city: Paw Paw
country: United States
facility: Study Facility
state: Michigan
city: Saginaw
country: United States
facility: Test Facility
state: Michigan
city: Edina
country: United States
facility: Research Facility
state: Minnesota
city: Jackson
country: United States
facility: Research Site
state: Mississippi
city: St Louis
country: United States
facility: Test Facility
state: Missouri
city: Billings
country: United States
facility: Site Facility
state: Montana
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Site Facility
state: Nevada
city: Reno
country: United States
facility: Test Facility
state: Nevada
city: Moorestown
country: United States
facility: Test Facility
state: New Jersey
city: New York
country: United States
facility: Research Facility
state: New York
city: Raleigh
country: United States
facility: Test Facility
state: North Carolina
city: Winston Salem
country: United States
facility: Study Facility
state: North Carolina
city: Winston-Salem
country: United States
facility: Site Facility
state: North Carolina
city: Beachwood
country: United States
facility: Research Facility
state: Ohio
city: Centerville
country: United States
facility: Test Facility
state: Ohio
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Cincinnati
country: United States
facility: Study Facility
state: Ohio
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Site Facility
state: Ohio
city: Columbus
country: United States
facility: Test Facility
state: Ohio
city: Columbus
country: United States
facility: Test Facility
state: Ohio
city: Dayton
country: United States
facility: Research Facility
state: Ohio
city: Englewood
country: United States
facility: Test Facility
state: Ohio
city: Oklahoma City
country: United States
facility: Test Facility
state: Oklahoma
city: Tulsa
country: United States
facility: Test Facility
state: Oklahoma
city: Eugene
country: United States
facility: Site Facility
state: Oregon
city: Philadelphia
country: United States
facility: Research Facility
state: Pennsylvania
city: Bristol
country: United States
facility: Study Facility
state: Tennessee
city: Chattanooga
country: United States
facility: Research Facility
state: Tennessee
city: Nashville
country: United States
facility: Research Facility
state: Tennessee
city: Austin
country: United States
facility: Site Facility
state: Texas
city: Carrolton
country: United States
facility: Research Facility
state: Texas
city: Corpus Christi
country: United States
facility: Site Facility
state: Texas
city: Dallas
country: United States
facility: Research Facility
state: Texas
city: Farmers Branch
country: United States
facility: Test Facility
state: Texas
city: Houston
country: United States
facility: Research Facility
state: Texas
city: Irving
country: United States
facility: Research Facility
state: Texas
city: Midland
country: United States
facility: Research Facility
state: Texas
city: Richardson
country: United States
facility: Research Facility
state: Texas
city: San Antonio
country: United States
facility: Site Facility
state: Texas
city: San Antonio
country: United States
facility: Test Facility
state: Texas
city: Salt Lake City
country: United States
facility: Study Facility
state: Utah
city: West Valley City
country: United States
facility: Research Facility
state: Utah
city: Newport News
country: United States
facility: Research Facility
state: Virginia
city: Richmond
country: United States
facility: Study Facility
state: Virginia
city: Richmond
country: United States
facility: Test Facility
state: Virginia
city: Richmond
country: United States
facility: Site Facility
state: Virginia
city: Virginia Beach
country: United States
facility: Research Facility
state: Virginia
city: Virginia Beach
country: United States
facility: Research Facility
state: Virginia
city: Seattle
country: United States
facility: Site Facility
state: Washington
city: Tacoma
country: United States
facility: Research Facility
state: Washington
city: Tacoma
country: United States
facility: Test Facility
state: Washington
city: Charleston
country: United States
facility: Research Site
state: West Virginia
Study officials:
affiliation: Procter and Gamble
name: Johna Lucas, MD
role: STUDY_DIRECTOR
References: