NCT00401245

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

The Effect of Dose Titration and Dose Tapering on the Tolerability of DVS SR in Women With Vasomotor Symptoms Associated With Menopause: The PRIMMUS (PRIstiq for Managing Menopause and Understanding Symptoms) Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Vasomotor Symptoms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-11-20
• Last updated: 2011-10-26
• Results posted: 2011-10-12

Locations

74 sites across 2 countries: United States, Canada