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

NCT00683800 | Completed Phase 3 Results DMC

• 2 other identifiers: 3151A2-3353B2061011
• Study Type: interventional
• Target: 2,186
• Locations: 2 countries
• Sites: 121

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.

Conditions

Vasomotor Symptoms

Keywords

Menopause; Hot Flush; Hot Flash; Desvenlafaxine succinate Sustained Release

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (21)

• Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes

  Baseline and Week 12

• Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes

  Baseline, Week 4 and Week 12

• Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes

  Baseline, Week 4 and Week 12

• Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes

  Week 12

• Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12

  Baseline, Month 6 and Month 12

Other Outcomes (4)

• Number of Participants With Adjudicated Cerebrovascular Events - Any Stroke

  Baseline up to Month 12

• Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA

  Baseline up to Month 12

• Number of Participants With Ischemic Heart Disease

  Baseline up to Month 12

Study Arms (2)

1

EXPERIMENTAL

desvenlafaxine succinate (DVS) SR

Drug: desvenlafaxine succinate (DVS) SR

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

desvenlafaxine succinate (DVS) SR DRUG

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.

1

Placebo DRUG

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.

2

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (121)

Pfizer Investigational Site

Birmingham, Alabama, 35235, United States

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Mobile, Alabama, 36608, United States

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Montgomery, Alabama, 36106, United States

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Glendale, Arizona, 85308, United States

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Peoria, Arizona, 85381, United States

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Tucson, Arizona, 85710, United States

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Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85715, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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Little Rock, Arkansas, 72223, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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San Diego, California, 92123, United States

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Vista, California, 92083, United States

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Walnut Creek, California, 94598, United States

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Colorado Springs, Colorado, 80910, United States

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Denver, Colorado, 80218, United States

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Englewood, Colorado, 80112, United States

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Longmont, Colorado, 80501, United States

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New London, Connecticut, 06320, United States

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Newark, Delaware, 19713, United States

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Brooksville, Florida, 34601, United States

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Clearwater, Florida, 33759, United States

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Clearwater, Florida, 33761, United States

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Daytona Beach, Florida, 32114, United States

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Fort Myers, Florida, 33916, United States

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Gainesville, Florida, 32610, United States

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Lake Worth, Florida, 33461, United States

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New Port Richey, Florida, 34652, United States

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Palm Harbor, Florida, 34684, United States

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Pembroke Pines, Florida, 33024, United States

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South Miami, Florida, 33143, United States

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Tampa, Florida, 33606, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30033, United States

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Decatur, Georgia, 30319, United States

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Savannah, Georgia, 31406, United States

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Boise, Idaho, 83702, United States

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Idaho Falls, Idaho, 83404, United States

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Indianapolis, Indiana, 46202, United States

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Indianapolis, Indiana, 46260, United States

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South Bend, Indiana, 46601, United States

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Overland Park, Kansas, 66210, United States

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Lexington, Kentucky, 40509, United States

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Louisville, Kentucky, 40291, United States

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New Orleans, Louisiana, 70114, United States

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Scarborough, Maine, 04074, United States

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Ann Arbor, Michigan, 48106, United States

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Brooklyn Center, Minnesota, 55430, United States

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Creve Coeur, Missouri, 63141, United States

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Billings, Montana, 59101, United States

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Billings, Montana, 59102, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89109, United States

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Las Vegas, Nevada, 89146, United States

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Reno, Nevada, 89502, United States

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Lebanon, New Hampshire, 03756, United States

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New Brunswick, New Jersey, 08901, United States

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Albuquerque, New Mexico, 87102, United States

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New York, New York, 10032, United States

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Winston-Salem, North Carolina, 27103, United States

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Bismarck, North Dakota, 58501, United States

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Fargo, North Dakota, 58104, United States

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Jamestown, North Dakota, 58401, United States

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Akron, Ohio, 44311, United States

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Cincinnati, Ohio, 45267-0457, United States

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Cleveland, Ohio, 44122, United States

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Englewood, Ohio, 45322, United States

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Oklahoma City, Oklahoma, 73112-4481, United States

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Eugene, Oregon, 97401, United States

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Medford, Oregon, 97504, United States

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Erie, Pennsylvania, 16502, United States

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Erie, Pennsylvania, 16507-1411, United States

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Jenkintown, Pennsylvania, 19046, United States

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Philadelphia, Pennsylvania, 19114, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Wexford, Pennsylvania, 15090, United States

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Warwick, Rhode Island, 02886, United States

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Greer, South Carolina, 29651, United States

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Hilton Head Island, South Carolina, 29926, United States

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Sioux Falls, South Dakota, 57104, United States

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Sioux Falls, South Dakota, 57105, United States

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Watertown, South Dakota, 57201, United States

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Chattanooga, Tennessee, 37404, United States

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Knoxville, Tennessee, 37920, United States

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Nashville, Tennessee, 37203, United States

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Dallas, Texas, 75234, United States

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Houston, Texas, 77030, United States

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Midland, Texas, 79705, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78229, United States

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Waco, Texas, 76712, United States

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Salt Lake City, Utah, 84117, United States

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Sandy City, Utah, 84070, United States

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Burlington, Vermont, 05401, United States

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Norfolk, Virginia, 23502, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23294, United States

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Seattle, Washington, 98105, United States

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Menomonee Falls, Wisconsin, 53051, United States

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Calgary, Alberta, T2N 4L7, Canada

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Coquitlam, British Columbia, V3K 3V9, Canada

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Surrey, British Columbia, V4A 2H9, Canada

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Winnipeg, Manitoba, R3T 2E8, Canada

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Antigonish, Nova Scotia, B2G 2C2, Canada

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Corunna, Ontario, N0N 1G0, Canada

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Ottawa, Ontario, K1H 7W9, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M4S 1Y2, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Gatineau, Quebec, J9A 1K7, Canada

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L'Ancienne-Lorette, Quebec, G2E 2X1, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Québec, Quebec, G1S 2L6, Canada

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Saint Romuald, Quebec, G6W 5M6, Canada

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Saint-Janvier, Quebec, J7J 2K8, Canada

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Shawinigan, Quebec, G9N 2H6, Canada

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Sherbrooke, Quebec, J1H 4J6, Canada

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Related Publications (3)

• 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.

  PMID: 23266840 DERIVED

• 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.

  PMID: 23266839 DERIVED

• 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.

  PMID: 23010882 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hot Flashes

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Limitations and Caveats

GCS scales were analyzed only for main study efficacy population.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 17, 2011
• Results First Posted: August 17, 2011

Record last verified: 2011-07

Locations

US (102); CA (19)