Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause

• ClinicalTrials.gov Identifier: NCT00256685
• Recruitment Status: Completed
• First Posted: November 21, 2005
• Last Update Posted: May 19, 2006
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: November 17, 2005
• First Posted Date: November 21, 2005
• Last Update Posted Date: May 19, 2006
• Study Start Date: September 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: November 17, 2005): Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 17, 2005): Sleep, mood
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause
• Official Title: A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
• Brief Summary: The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double; Primary Purpose: Treatment

Condition

• Menopause
• Hot Flashes
• Sleep Disorders

• Intervention: Drug: DVS-233 SR
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: November 17, 2005): 568
• Original Enrollment: Same as current
• Study Completion Date: July 2005
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Generally healthy, postmenopausal women who seek treatment for hot flushes
• Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening
• Body Mass Index (BMI) less than or equal to 40 kg/m2

Other inclusions apply.

Exclusion Criteria:

• Hypersensitivity to Venlafaxine
• History of seizure disorder
• History of myocardial infarction or unstable angina within 6 months

Other exclusions apply.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00256685
• Other Study ID Numbers: 3151A2-319
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: May 2006