Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women

• ClinicalTrials.gov Identifier: NCT00369434
• Recruitment Status: Completed
• First Posted: August 29, 2006
• Last Update Posted: June 1, 2007
• 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: August 25, 2006
• First Posted Date: August 29, 2006
• Last Update Posted Date: June 1, 2007
• Study Start Date: June 2006
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: August 25, 2006): The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 25, 2006)

• The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]).
• The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS).

• 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 of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
• Official Title: A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of DVS SR for Treatment of Vasomotor Symptoms Associated With Menopause
• Brief Summary: The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women.
• Detailed Description: To assess the efficacy and safety of 100 mg and 150 mg of DVS SR in comparison to placebo for the treatment of moderate to severe VMS associated with menopause, as well as additional outcome indicators such as sleep disruptions, overall climacteric symptoms, mood changes, somatic symptoms, and overall satisfaction with DVS SR in postmenopausal women.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double; Primary Purpose: Treatment

Condition

• Menopause
• Vasomotor System

• Intervention: Drug: Desvenlafaxine succinate sustained-release (DVS SR)
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: August 25, 2006): 450
• Original Enrollment: Same as current
• Actual Study Completion Date: February 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Generally healthy, postmenopausal women who seek treatment for hot flushes
• Body Mass Index (BMI) less than or equal to 40 kg/m2

Other inclusions apply.

Exclusion Criteria:

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

Other exclusions apply.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00369434
• Other Study ID Numbers: 3151A2-337
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• 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 2007