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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00683800
Other study ID # 3151A2-3353
Secondary ID B2061011
Status Completed
Phase Phase 3
First received May 21, 2008
Last updated July 21, 2011
Start date June 2008
Est. completion date May 2010

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2186
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
desvenlafaxine succinate (DVS) SR
Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.
Placebo
Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.

Locations

Country Name City State
Canada Pfizer Investigational Site Antigonish Nova Scotia
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Coquitlam British Columbia
Canada Pfizer Investigational Site Corunna Ontario
Canada Pfizer Investigational Site Gatineau Quebec
Canada Pfizer Investigational Site L'Ancienne-Lorette Quebec
Canada Pfizer Investigational Site Ottawa Ontario
Canada Pfizer Investigational Site Pointe Claire Quebec
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site Saint-Janvier Quebec
Canada Pfizer Investigational Site Sarnia Ontario
Canada Pfizer Investigational Site Shawinigan Quebec
Canada Pfizer Investigational Site Sherbrooke Quebec
Canada Pfizer Investigational Site St-Romuald Quebec
Canada Pfizer Investigational Site Surrey British Columbia
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Winnipeg Manitoba
United States Pfizer Investigational Site Akron Ohio
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Billings Montana
United States Pfizer Investigational Site Billings Montana
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Bismarck North Dakota
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Brooklyn Center Minnesota
United States Pfizer Investigational Site Brooksville Florida
United States Pfizer Investigational Site Burlington Vermont
United States Pfizer Investigational Site Chattanooga Tennessee
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Colorado Springs Colorado
United States Pfizer Investigational Site Creve Coeur Missouri
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Daytona Beach Florida
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Englewood Colorado
United States Pfizer Investigational Site Englewood Ohio
United States Pfizer Investigational Site Erie Pennsylvania
United States Pfizer Investigational Site Erie Pennsylvania
United States Pfizer Investigational Site Eugene Oregon
United States Pfizer Investigational Site Fargo North Dakota
United States Pfizer Investigational Site Fort Myers Florida
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Glendale Arizona
United States Pfizer Investigational Site Greer South Carolina
United States Pfizer Investigational Site Hilton Head Island South Carolina
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Idaho Falls Idaho
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jamestown North Dakota
United States Pfizer Investigational Site Jenkintown Pennsylvania
United States Pfizer Investigational Site Jonesboro Arkansas
United States Pfizer Investigational Site Knoxville Tennessee
United States Pfizer Investigational Site Lake Worth Florida
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Lebanon New Hampshire
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Lincoln Nebraska
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Longmont Colorado
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Medford Oregon
United States Pfizer Investigational Site Menomonee Falls Wisconsin
United States Pfizer Investigational Site Midland Texas
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site Montgomery Alabama
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Brunswick New Jersey
United States Pfizer Investigational Site New London Connecticut
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site New Port Richey Florida
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Newark Delaware
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Palm Harbor Florida
United States Pfizer Investigational Site Pembroke Pines Florida
United States Pfizer Investigational Site Peoria Arizona
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Plano Texas
United States Pfizer Investigational Site Reno Nevada
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Sandy Utah
United States Pfizer Investigational Site Savannah Georgia
United States Pfizer Investigational Site Scarborough Maine
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Sioux Falls South Dakota
United States Pfizer Investigational Site Sioux Falls South Dakota
United States Pfizer Investigational Site South Bend Indiana
United States Pfizer Investigational Site South Miami Florida
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Vista California
United States Pfizer Investigational Site Waco Texas
United States Pfizer Investigational Site Walnut Creek California
United States Pfizer Investigational Site Warwick Rhode Island
United States Pfizer Investigational Site Watertown South Dakota
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site Wexford Pennsylvania
United States Pfizer Investigational Site Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4 The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Baseline and Week 4 No
Primary Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12 The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Baseline and Week 12 No
Primary Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4 Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes. Baseline and Week 4 No
Primary Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12 Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes. Baseline and Week 12 No
Primary Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting. Baseline up to Month 12 Yes
Secondary Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes A mean decrease from baseline of at least 5.35 moderate to severe hot flushes at week 12 in the participants was considered clinically meaningful. Baseline and Week 12 No
Secondary Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Baseline, Week 4 and Week 12 No
Secondary Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Baseline, Week 4 and Week 12 No
Secondary Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes Time to response was defined as the time-to-first 50% reduction in the average daily number of moderate to severe hot flushes over 3 consecutive days. Week 12 No
Secondary Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12 The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Adjusted mean was calculated by using change from baseline as response variable, treatment as factor, and baseline as covariate using the observed cases. Baseline, Month 6 and Month 12 No
Secondary Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12 Severity: mild (heat sensation without sweating); moderate (heat sensation with sweating; able to continue activity); severe (heat sensation with sweating; causing cessation of activity). Average daily severity of hot flushes= (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). Days with no hot flushes: severity score=0. As it was derived from count data, there was no maximum; minimum score=0; higher values= worse outcomes. Adjusted mean: calculated using change from baseline=response variable, treatment=factor and baseline=covariate using observed cases. Baseline, Month 6 and Month 12 No
Secondary Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12 GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms. Baseline and Week 12 No
Secondary Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6 GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms. Baseline and Month 6 No
Secondary Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12 GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms. Baseline and Month 12 No
Secondary Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12 PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). Week 12 No
Secondary Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6 PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). Month 6 No
Secondary Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12 PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). Month 12 No
Secondary Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12 PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). Week 12 No
Secondary Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6 PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). Month 6 No
Secondary Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12 PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe). Month 12 No
Secondary Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12 PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). Week 12 No
Secondary Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6 PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). Month 6 No
Secondary Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12 PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). Month 12 No
Secondary Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12 PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). Week 12 No
Secondary Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6 PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). Month 6 No
Secondary Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12 PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse). Month 12 No
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