Status:

COMPLETED

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

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Menopause

Vasomotor System

Eligibility:

FEMALE

Phase:

PHASE3

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 Vas...

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 indicator...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

June 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2007

Estimated Enrollment :

450 Patients enrolled

Trial Details

Trial ID

NCT00369434

Start Date

June 1 2006

End Date

February 1 2007

Last Update

June 1 2007

Active Locations (34)

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Page 1 of 9 (34 locations)

1

Montgomery, Alabama, United States, 36106

2

Peoria, Arizona, United States, 85381

3

Upland, California, United States, 91786

4

Colorado Springs, Colorado, United States, 80910