Clinical trial NCT00160173: Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
Official title: Efficacy Study Comparing 0.9 g and 1.25 g EstroGelÂ® 0.03% Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postmenopausal Symptoms
Keywords: Post menopausal vasomotor symptoms
Lead sponsor: ASCEND Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Solvay Pharmaceuticals
First posted: 2005-09-12
Enrollment: 221
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.

Detailed description: The primary objective of this study was to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.25 g EstroGel® 0.03% doses with placebo. Effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters.

Eligibility criteria: Inclusion Criteria:

* Women 45-65 years
* naturally or surgically postmenopausal
* experiencing hot flushes

Exclusion Criteria:

* hypersensitivity to estrogen replacement therapy
* pregnancy or lactating
* abnormal PAP smear
* history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 112
state: Alabama
city: Mobile
country: United States
facility: Site 74
state: Alabama
city: Montgomery
country: United States
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state: Alabama
city: Tucson
country: United States
facility: Site 34
state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Jonesboro
country: United States
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state: Arkansas
city: Little Rock
country: United States
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state: Arkansas
city: Little Rock
country: United States
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state: Arkansas
city: Carmichael
country: United States
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state: California
city: Encinitas
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: Avon
country: United States
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state: Connecticut
city: Bridgeport
country: United States
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state: Connecticut
city: Groton
country: United States
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state: Connecticut
city: Hartford
country: United States
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state: Connecticut
city: New Britain
country: United States
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state: Connecticut
city: Southport
country: United States
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state: Connecticut
city: Waterbury
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state: Connecticut
city: West Hartford
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state: Connecticut
city: Aventura
country: United States
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state: Florida
city: Aventura
country: United States
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state: Florida
city: Clearwater
country: United States
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city: Clearwater
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city: Daytona Beach
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city: Melbourne
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city: Miami
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city: Pinellas Park
country: United States
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state: Florida
city: Spring Hill
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city: Tampa
country: United States
facility: Site 100
state: Florida
city: West Palm Beach
country: United States
facility: Site 77
state: Florida
city: Alpharetta
country: United States
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state: Georgia
city: Alpharetta
country: United States
facility: Site 81
state: Georgia
city: Atlanta
country: United States
facility: Site 28
state: Georgia
city: Atlanta
country: United States
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state: Georgia
city: Decatur
country: United States
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state: Georgia
city: Douglasville
country: United States
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state: Georgia
city: Powder Springs
country: United States
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state: Georgia
city: Savannah
country: United States
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state: Georgia
city: Savannah
country: United States
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state: Georgia
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state: Idaho
city: Champaign
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state: Illinois
city: Chicago
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state: Illinois
city: Chicago
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city: Peoria
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state: Illinois
city: Evansville
country: United States
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state: Indiana
city: South Bend
country: United States
facility: Site 45
state: Indiana
city: Waterloo
country: United States
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state: Iowa
city: Lexington
country: United States
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state: Kentucky
city: Baton Rouge
country: United States
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state: Louisiana
city: Metairie
country: United States
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state: Louisiana
city: New Orleans
country: United States
facility: Site 65
state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Baltimore
country: United States
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state: Maryland
city: Ann Arbor
country: United States
facility: Site 66
state: Michigan
city: Chaska
country: United States
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state: Minnesota
city: Creve Coeur
country: United States
facility: Site 29
state: Missouri
city: Saint Louis
country: United States
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state: Missouri
city: Saint Louis
country: United States
facility: Site 67
state: Missouri
city: Billings
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state: Montana
city: Lincoln
country: United States
facility: Site 56
state: Nebraska
city: Las Vegas
country: United States
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state: Nevada
city: Reno
country: United States
facility: Site 40
state: Nevada
city: Olean
country: United States
facility: Site102
state: New York
city: Fayetteville
country: United States
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state: North Carolina
city: New Bern
country: United States
facility: Site 60
state: North Carolina
city: Raleigh
country: United States
facility: Site 59
state: North Carolina
city: Winston-Salem
country: United States
facility: Site 38
state: North Carolina
city: Winston-Salem
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state: North Carolina
city: Winston-Salem
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state: North Carolina
city: Cincinnati
country: United States
facility: Site 86
state: Ohio
city: Edmond
country: United States
facility: Site 101
state: Oklahoma
city: Eugene
country: United States
facility: Site 89
state: Oregon
city: Medford
country: United States
facility: Site 111
state: Oregon
city: Portland
country: United States
facility: Site 64
state: Oregon
city: Erie
country: United States
facility: Site 113
state: Pennsylvania
city: Pottstown
country: United States
facility: Site 98
state: Pennsylvania
city: Greenville
country: United States
facility: Site 33
state: South Carolina
city: Chattanooga
country: United States
facility: Site 9
state: Tennessee
city: Memphis
country: United States
facility: Site 92
state: Tennessee
city: Nashville
country: United States
facility: Site 76
state: Tennessee
city: Carrollton
country: United States
facility: Site 83
state: Texas
city: Conroe
country: United States
facility: Site 17
state: Texas
city: Corpus Christi
country: United States
facility: Site 23
state: Texas
city: Corpus Christi
country: United States
facility: Site 25
state: Texas
city: Dallas
country: United States
facility: Site 30
state: Texas
city: Dallas
country: United States
facility: Site 90
state: Texas
city: Houston
country: United States
facility: Site 10
state: Texas
city: Houston
country: United States
facility: Site 110
state: Texas
city: Houston
country: United States
facility: Site 14
state: Texas
city: Houston
country: United States
facility: Site 27
state: Texas
city: Houston
country: United States
facility: Site 48
state: Texas
city: Houston
country: United States
facility: Site 51
state: Texas
city: Houston
country: United States
facility: Site 71
state: Texas
city: Houston
country: United States
facility: Site 73
state: Texas
city: San Antonio
country: United States
facility: Site 43
state: Texas
city: San Antonio
country: United States
facility: Site 62
state: Texas
city: San Antonio
country: United States
facility: Site 80
state: Texas
city: Texarkana
country: United States
facility: Site 7
state: Texas
city: Salt Lake City
country: United States
facility: Site 44
state: Utah
city: Salt Lake City
country: United States
facility: Site 94
state: Utah
city: Norfolk
country: United States
facility: Site 47
state: Virginia
city: Richmond
country: United States
facility: Site 106
state: Virginia
city: Richmond
country: United States
facility: Site 41
state: Virginia
city: Seattle
country: United States
facility: Site 4
state: Washington
city: Tacoma
country: United States
facility: Site 52
state: Washington
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: