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

Hypoactive Sexual Desire Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467259
• Other study ID #: 2007004
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2007
• Last updated: November 10, 2011
• Start date: April 2007
• Est. completion date: January 2009

Study information

• Verified date: November 2011
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1271
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Testosterone Transdermal System
Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
• Placebo patch
placebo patch, changed twice a week for 52 weeks

Locations

Country	Name	City	State
United States	Research Facility	Alpharetta	Georgia
United States	Research Facility	Anaheim	California
United States	Research Facility	Atlanta	Georgia
United States	Site Facility	Austin	Texas
United States	Research Facility	Baltimore	Maryland
United States	Study Facility	Baltimore	Maryland
United States	Research Facility	Beachwood	Ohio
United States	Research Site	Berkeley	California
United States	Site Facility	Billings	Montana
United States	Research Facility	Bingham Farm	Michigan
United States	Research Facility	Birmingham	Alabama
United States	Study Facility	Birmingham	Alabama
United States	Study Facility	Boston	Massachusetts
United States	Research Facility	Boynton Beach	Florida
United States	Study Facility	Bristol	Tennessee
United States	Research Facility	Carrolton	Texas
United States	Test Facility	Centerville	Ohio
United States	Test Facility	Champaign	Illinois
United States	Test Facility	Chandler	Arizona
United States	Research Site	Charleston	West Virginia
United States	Research Facility	Chattanooga	Tennessee
United States	Test Facility	Chicago	Illinois
United States	Research Facility	Cincinnati	Ohio
United States	Research Facility	Cincinnati	Ohio
United States	Study Facility	Cincinnati	Ohio
United States	Site Facility	Clearwater	Florida
United States	Research Site	Cleveland	Ohio
United States	Site Facility	Cleveland	Ohio
United States	Test Facility	Columbus	Ohio
United States	Test Facility	Columbus	Ohio
United States	Site Facility	Corpus Christi	Texas
United States	Research Facility	Dallas	Texas
United States	Research Facility	Dayton	Ohio
United States	Site Facility	Daytona Beach	Florida
United States	Site Facility	Decatur	Georgia
United States	Test Facility	Denver	Colorado
United States	Site Facility	Douglasville	Georgia
United States	Research Facility	Edina	Minnesota
United States	Test Facility	Englewood	Ohio
United States	Site Facility	Eugene	Oregon
United States	Test Facility	Farmers Branch	Texas
United States	Research Facility	Gainesville	Florida
United States	Research Facility	Houston	Texas
United States	Study Facility	Idaho Falls	Idaho
United States	Test Facility	Indianapolis	Indiana
United States	Research Facility	Irving	Texas
United States	Research Site	Jackson	Mississippi
United States	Research Site	Jacksonville	Florida
United States	Site Facility	Jonesboro	Arkansas
United States	Site Facility	Jupiter	Florida
United States	Site Facility	Las Vegas	Nevada
United States	Site Facility	Little Rock	Arkansas
United States	Research Facility	Longmont	Colorado
United States	Site Facility	Louisville	Kentucky
United States	Test Facility	Miami	Florida
United States	Research Facility	Midland	Texas
United States	Research Facility	Mobile	Alabama
United States	Research Facility	Montgomery	Alabama
United States	Test Facility	Moorestown	New Jersey
United States	Research Facility	Nashville	Tennessee
United States	Test Facility	New London	Connecticut
United States	Research Facility	New York	New York
United States	Research Facility	Newport News	Virginia
United States	Test Facility	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Facility	Overland Park	Kansas
United States	Research Facility	Palm Desert	California
United States	Research Facility	Pasadena	California
United States	Study Facility	Paw Paw	Michigan
United States	Study Facility	Peoria	Arizona
United States	Research Facility	Philadelphia	Pennsylvania
United States	Research Facility	Phoenix	Arizona
United States	Research Facility	Phoenix	Arizona
United States	Research Facility	Pinellas Park	Florida
United States	Research Facility	Plantation	Florida
United States	Test Facility	Raleigh	North Carolina
United States	Test Facility	Reno	Nevada
United States	Research Facility	Richardson	Texas
United States	Site Facility	Richmond	Virginia
United States	Study Facility	Richmond	Virginia
United States	Test Facility	Richmond	Virginia
United States	Site Facility	Roswell	Georgia
United States	Test Facility	Saginaw	Michigan
United States	Study Facility	Salt Lake City	Utah
United States	Site Facility	San Antonio	Texas
United States	Test Facility	San Antonio	Texas
United States	Research Facility	San Diego	California
United States	Research Facility	San Ramon	California
United States	Test Facility	Santa Rosa	California
United States	Test Facility	Savannah	Georgia
United States	Research Facility	Scottsdale	Arizona
United States	Site Facility	Seattle	Washington
United States	Study Facility	South Miami	Florida
United States	Test Facility	St Louis	Missouri
United States	Research Facility	Tacoma	Washington
United States	Test Facility	Tacoma	Washington
United States	Research Site	Tampa	Florida
United States	Research Facility	Tucson	Arizona
United States	Research Site	Tucson	Arizona
United States	Test Facility	Tulsa	Oklahoma
United States	Study Facility	Tuscon	Arizona
United States	Site Facility	Upland	California
United States	Test Facility	Vero Beach	Florida
United States	Research Facility	Virginia Beach	Virginia
United States	Research Facility	Virginia Beach	Virginia
United States	Research Facility	Vista	California
United States	Site Facility	Vista	California
United States	Research Facility	Washington	District of Columbia
United States	Study Facility	Waterbury	Connecticut
United States	Research Facility	West Palm Beach	Florida
United States	Research Facility	West Valley City	Utah
United States	Site Facility	Westlake Village	California
United States	Research Facility	Weston	Florida
United States	Study Facility	Winston Salem	North Carolina
United States	Site Facility	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1	Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies	52 weeks	No
Secondary	Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1	Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies	52 weeks	No