Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause
NCT ID: NCT00421031
Last Updated: 2007-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
540 participants
INTERVENTIONAL
2003-12-31
2004-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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DVS-233 SR
Eligibility Criteria
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Inclusion Criteria
2. Minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week at screening:
* Moderate hot flush: warm sensation with sweating, does not disrupt activity.
* Severe hot flush: hot sensation with sweating, disrupts activity.
3. Subjects must have body mass index (BMI) less than or equal to 40 using the nomograph for BMI.
Exclusion Criteria
2. Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks prior to screening; use of transdermal hormone products within 8 weeks prior to screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to screening; use of intrauterine progestins within 8 weeks prior to screening; use of progestin implants or estrogen injectables within 3 months prior to screening; use of estrogen pellet or progestin injectables within 6 months prior to screening.
3. History of a seizure disorder other than a single childhood febrile seizure.
FEMALE
Yes
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Montgomery, Alabama, United States
Peoria, Arizona, United States
San Diego, California, United States
Stanford, California, United States
Colorado Springs, Colorado, United States
Newark, Delaware, United States
Aventura, Florida, United States
Fort Myers, Florida, United States
Inverness, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Orange City, Florida, United States
Pinellas Park, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
West Venice, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Newburgh, Indiana, United States
Lexington, Kentucky, United States
Shreveport, Louisiana, United States
Portland, Maine, United States
Chaska, Minnesota, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Billings, Montana, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Winston-Salem, North Carolina, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Erie, Pennsylvania, United States
Wexford, Pennsylvania, United States
Greenville, South Carolina, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Countries
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References
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Speroff L, Gass M, Constantine G, Olivier S; Study 315 Investigators. Efficacy and tolerability of desvenlafaxine succinate treatment for menopausal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):77-87. doi: 10.1097/01.AOG.0000297371.89129.b3.
Other Identifiers
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3151A2-315
Identifier Type: -
Identifier Source: org_study_id
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