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The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms

NCT ID: NCT00401245

Last Updated: 2011-10-26

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-01-31

Brief Summary

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Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.

Detailed Description

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Conditions

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Vasomotor Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Group Type ACTIVE_COMPARATOR

desvenlafaxine succinate sustained release

Intervention Type DRUG

Titration 100 mg

B

Group Type ACTIVE_COMPARATOR

desvenlafaxine succinate sustained release

Intervention Type DRUG

Titration 50 mg

C

Group Type ACTIVE_COMPARATOR

desvenlafaxine succinate sustained release

Intervention Type DRUG

Titration 25 mg, 50mg

D

Group Type ACTIVE_COMPARATOR

desvenlafaxine succinate sustained release

Intervention Type DRUG

Titration 25 mg

E

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Tapering placebo

F

Group Type ACTIVE_COMPARATOR

desvenlafaxine succinate sustained release

Intervention Type DRUG

Tapering 50 mg, placebo

G

Group Type ACTIVE_COMPARATOR

desvenlafaxine succinate sustained release

Intervention Type DRUG

Tapering 50 mg, 25 mg

H

Group Type PLACEBO_COMPARATOR

desvenlafaxine succinate sustained release

Intervention Type DRUG

Tapering 50 mg QOD

Interventions

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desvenlafaxine succinate sustained release

Titration 100 mg

Intervention Type DRUG

desvenlafaxine succinate sustained release

Titration 50 mg

Intervention Type DRUG

desvenlafaxine succinate sustained release

Titration 25 mg, 50mg

Intervention Type DRUG

desvenlafaxine succinate sustained release

Titration 25 mg

Intervention Type DRUG

Placebo

Tapering placebo

Intervention Type DRUG

desvenlafaxine succinate sustained release

Tapering 50 mg, placebo

Intervention Type DRUG

desvenlafaxine succinate sustained release

Tapering 50 mg, 25 mg

Intervention Type DRUG

desvenlafaxine succinate sustained release

Tapering 50 mg QOD

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Generally healthy, postmenopausal woman who seeks treatment for hot flushes.
* Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels \>40 mIU/mL.

Exclusion Criteria

* History of a seizure disorder other than a single childhood febrile seizure.
* History or presence of clinically important hepatic or renal disease or other medical disease.
* Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Tucson, Arizona, United States

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Tucson, Arizona, United States

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Beverly Hills, California, United States

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Encinitas, California, United States

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Foothill Ranch, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Upland, California, United States

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Denver, Colorado, United States

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Longmont, Colorado, United States

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Clearwater, Florida, United States

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Crystal River, Florida, United States

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DeLand, Florida, United States

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Gainesville, Florida, United States

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Lake Worth, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Palm Harbor, Florida, United States

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Tampa, Florida, United States

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Idaho Falls, Idaho, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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South Bend, Indiana, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Metairie, Louisiana, United States

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Metairie, Louisiana, United States

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Canton, Michigan, United States

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Ypsilanti, Michigan, United States

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Billings, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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New Brunswick, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Fargo, North Dakota, United States

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Cleveland, Ohio, United States

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Eugene, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Watertown, South Dakota, United States

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Carrollton, Texas, United States

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Houston, Texas, United States

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Hurst, Texas, United States

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Midland, Texas, United States

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Norfolk, Virginia, United States

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Norfolk, Virginia, United States

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Seattle, Washington, United States

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Calgary, Alberta, Canada

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Coquitlam, British Columbia, Canada

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Langley, British Columbia, Canada

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Surrey, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Newmarket, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Saint Romuald, Quebec, Canada

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Shawinigan, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Countries

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United States Canada

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A2-405&StudyName=The%20Effect%20Of%20Dose%20Titration%20And%20Dose%20Tapering%20On%20The%20Tolerability%20Of%20DVS%20SR%20In%20Women%20With%20Vasomotor%20Symptoms

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

Other Identifiers

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3151A2-405

Identifier Type: -

Identifier Source: org_study_id