Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013)

Phase 3 Completed 946 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To investigate efficacy and safety of 4 doses of esmirtazapine, compared to placebo, in the treatment of moderate to severe hot flushes (vasomotor symptoms) associated with the menopause. Co-primary efficacy endpoints are the frequency and severity of hot flushes after 4 and 12 weeks as compared to Baseline.

Timeline

Start: 2004-09-15
Primary completion: 2006-01-15
Completion: 2006-01-15

Publications

Results Birkhaeuser M, Bitzer J, Braat S, Ramos Y. Esmirtazapine treatment of postmenopausal vasomotor symptoms: two randomized controlled trials. Climacteric. 2019 Jun;22(3):312-322. doi: 10.1080/13697137.2018.1561664. Epub 2019 Feb 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esmirtazapine	Small molecule	2.25 mg	Oral
Subject	Esmirtazapine	Small molecule	4.5 mg	Oral
Subject	Esmirtazapine	Small molecule	9 mg	Oral
Subject	Esmirtazapine	Small molecule	18 mg	Oral

Indications

No indication recorded.