At a glance
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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
In Brief
A Phase 3 clinical trial evaluating desvenlafaxine succinate sustained release and Placebo for Vasomotor Symptoms. Completed, enrolled 500 participants across 74 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Titration 100 mg
Titration 50 mg
Titration 25 mg, 50mg
Titration 25 mg
Tapering placebo
Tapering 50 mg, placebo
Tapering 50 mg, 25 mg
Tapering 50 mg QOD