drugset / Trial / NCT00401245

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

NCT00401245

Phase 3 Completed 500 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Desvenlafaxine Other / unclassified 25 mg
Comparator Desvenlafaxine Other / unclassified 50 mg
Comparator Desvenlafaxine Other / unclassified 100 mg

Indications

No indication recorded.