Clinical trial NCT00683800: Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women
Official title: A Double-Blind, Randomized, Placebo-Controlled Study Assessing The Safety And Efficacy Of DVS SR For The Treatment Of Vasomotor Symptoms Associated With Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasomotor Symptoms
Keywords: Menopause
Hot Flush
Hot Flash
Desvenlafaxine succinate Sustained Release
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-23
Enrollment: 2186
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) in menopausal women.


Eligibility criteria: Inclusion Criteria:

* Generally healthy, postmenopausal women who seek treatment for hot flushes
* Body Mass Index (BMI) less than or equal to 34 kg/m\^2

Exclusion Criteria:

* Hypersensitivity to Venlafaxine
* Myocardial infarction an/or unstable angina within 6 months of screening
* History of seizure disorder

Primary outcomes:
measure: Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events
timeFrame: Baseline up to Month 12
Secondary outcomes:
measure: Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes
timeFrame: Baseline and Week 12
measure: Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes
timeFrame: Baseline, Week 4 and Week 12
measure: Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes
timeFrame: Baseline, Week 4 and Week 12
measure: Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes
timeFrame: Week 12
measure: Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12
timeFrame: Baseline and Month 12
measure: Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12
timeFrame: Month 12
measure: Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12
timeFrame: Month 12
measure: Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12
timeFrame: Month 12
measure: Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12
timeFrame: Month 12
Other outcomes:
measure: Number of Participants With Adjudicated Cerebrovascular Events - Any Stroke
timeFrame: Baseline up to Month 12
measure: Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA
timeFrame: Baseline up to Month 12
measure: Number of Participants With Ischemic Heart Disease
timeFrame: Baseline up to Month 12
measure: Number of Participants With Hepatic Events
timeFrame: Baseline up to Month 12
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Englewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Longmont
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: New London
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Brooksville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake Worth
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Idaho Falls
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: South Bend
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Scarborough
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Brooklyn Center
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Creve Coeur
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Reno
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Jamestown
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Akron
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Englewood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Erie
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Jenkintown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wexford
country: United States
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state: Pennsylvania
city: Warwick
country: United States
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state: Rhode Island
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Hilton Head Island
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Sioux Falls
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Chattanooga
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Midland
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Waco
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Sandy
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Menomonee Falls
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Coquitlam
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Antigonish
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Corunna
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Gatineau
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: L'Ancienne-Lorette
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saint-Janvier
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Shawinigan
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St-Romuald
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Archer DF, Pinkerton JV, Guico-Pabia CJ, Hwang E, Cheng RF; Study 3353 Investigators. Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year in women with vasomotor symptoms associated with menopause. Menopause. 2013 Jan;20(1):47-56. doi: 10.1097/gme.0b013e3182775fe9.
citation: Pinkerton JV, Archer DF, Guico-Pabia CJ, Hwang E, Cheng RF. Maintenance of the efficacy of desvenlafaxine in menopausal vasomotor symptoms: a 1-year randomized controlled trial. Menopause. 2013 Jan;20(1):38-46. doi: 10.1097/GME.0b013e318274699f.
citation: Pinkerton JV, Constantine G, Hwang E, Cheng RF; Study 3353 Investigators. Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial. Menopause. 2013 Jan;20(1):28-37. doi: 10.1097/gme.0b013e31826421a8.