Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women

Vasomotor Symptoms Clinical Trial

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

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

• Vasomotor Symptoms

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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