NCT00256685

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
568

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
Last Updated

May 19, 2006

Status Verified

May 1, 2006

First QC Date

November 17, 2005

Last Update Submit

May 17, 2006

Conditions

MenopauseHot FlashesSleep Disorders

Keywords

Menopause

Outcome Measures

Primary Outcomes (1)

  • Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12

Secondary Outcomes (1)

  • Sleep, mood

Interventions

DVS-233 SRDRUG

Eligibility Criteria

Age0 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hot FlashesSleep Wake Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNervous System DiseasesNeurologic ManifestationsMental Disorders

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2005

First Posted

November 21, 2005

Study Start

September 1, 2004

Study Completion

July 1, 2005

Last Updated

May 19, 2006

Record last verified: 2006-05