Clinical trial NCT00238732: Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
Official title: A Double-Blind, Randomized, Placebo-and Active-Controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Treatment of Moderate to Severe Vulvar/Vaginal Atrophy in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaginal Atrophy
Keywords: Vaginal Atrophy
Postmenopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-13
Enrollment: 650
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.


Eligibility criteria: Inclusion Criteria:

* Generally healthy, postmenopausal women, aged 40 to 65 years
* Intact uterus
* At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome

Exclusion Criteria:

* Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia
* Thrombophlebitis, thrombosis or thromboembolic disorders
* Neuro-ocular disease

Primary outcomes:
measure: Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
measure: Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Secondary outcomes:
measure: Vaginal pH at screening, and weeks 4 and 12.
measure: Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Oakland
country: United States
state: California
city: San Diego
country: United States
state: California
city: Upland
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Avon
country: United States
state: Connecticut
city: Groton
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Palm Springs
country: United States
state: Florida
city: Pinnellas Park
country: United States
state: Florida
city: Stuart
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Conyers
country: United States
state: Georgia
city: Douglasville
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Champaign
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Booklyn Center
country: United States
state: Minnesota
city: Chaska
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Kansas
country: United States
state: Mississippi
city: Creve Cour
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Livingston
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Jamestown
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Erie
country: United States
state: Pennsylvania
city: Media
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Hilton Head Island
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Denton
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Pinkerton JV, Bushmakin AG, Komm BS, Abraham L. Relationship between changes in vulvar-vaginal atrophy and changes in sexual functioning. Maturitas. 2017 Jun;100:57-63. doi: 10.1016/j.maturitas.2017.03.315. Epub 2017 Mar 22.