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Completed

NCT Number: NCT00369434

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

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.

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Key information

Conditions

Menopause Vasomotor System

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Montgomery, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Desvenlafaxine Succinate Sustained-Release (DVS SR)

Drug

Primary outcomes

  1. The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.

Secondary outcomes

  1. The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]).

  2. The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS).

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of DVS SR for Treatment of Vasomotor Symptoms Associated With Menopause

Important dates

Study start
2006
Study completion
2007
First posted
Aug 29, 2006
Registry last updated
Jun 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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