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The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms

NCT00401245 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2011-10-26

Study results available
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Summary

Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.

Conditions

Interventions

DRUG

desvenlafaxine succinate sustained release

Titration 100 mg

DRUG

desvenlafaxine succinate sustained release

Titration 50 mg

DRUG

desvenlafaxine succinate sustained release

Titration 25 mg, 50mg

DRUG

desvenlafaxine succinate sustained release

Titration 25 mg

DRUG

Placebo

Tapering placebo

DRUG

desvenlafaxine succinate sustained release

Tapering 50 mg, placebo

DRUG

desvenlafaxine succinate sustained release

Tapering 50 mg, 25 mg

DRUG

desvenlafaxine succinate sustained release

Tapering 50 mg QOD

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-01-31
Completion
2008-01-31

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 NCT00401245 on ClinicalTrials.gov