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Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women

NCT00683800 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2186

Last updated 2011-08-17

Study results available
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Summary

The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) in menopausal women.

Conditions

Interventions

DRUG

desvenlafaxine succinate (DVS) SR

Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.

DRUG

Placebo

Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00683800 on ClinicalTrials.gov