NCT00560833

Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)

A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Four Different Doses of Org 50081 in the Treatment of Moderate to Severe Vasomotor Symptoms Associated With the Menopause

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 943 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The most direct treatment of vasomotor symptions (hot flushes) may be by means of 5-HT2A receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing the number and intensity of hot flushes in preliminary trials. Also several Selective Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been investigated to manage hot flushes, confirming the role of the serotonergic system. In the present trial, the efficacy and safety of four different doses of esmirtazapine compared to placebo was investigated in women with moderate to severe vasomotor symptoms associated with the menopause. The primary study hypothesis was that esmirtazapine would show superior efficacy to placebo.

Conditions

• Menopause
• Vasomotor Symptoms

Interventions

Type	Name	Description
DRUG	esmirtazapine
DRUG	Placebo

Timeline

• Start date: 2004-10-15
• Primary completion: 2006-01-15
• Completion: 2006-01-15
• First posted: 2007-11-20
• Last updated: 2019-04-02
• Results posted: 2014-06-30