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

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

Outcome

Mixed primary results

paper Co-primary efficacy endpoints (daily frequency and severity of moderate to severe VMS, both at weeks 4 and 12) were based on participative LogPad daily diaries. PMID 30712391 ↗

registry analysis (superiority or other test); Placebo vs Esmirtazapine 4.5 mg; p <0.01; Difference between least squares means -1.6 (95% CI -2.7 to -0.5); ANCOVA NCT00535288 ↗

registry analysis (superiority or other test); Placebo vs Esmirtazapine 2.25 mg; p = 0.08; Difference between least squares means -1.0 (95% CI -2.1 to 0.1); ANCOVA NCT00535288 ↗

registry analysis (superiority or other test); Placebo vs Esmirtazapine 4.5 mg; p = 0.24; Difference between least squares means -0.05 (95% CI -0.11 to 0.02); ANCOVA NCT00535288 ↗

registry analysis (superiority or other test); Placebo vs Esmirtazapine 18 mg; p = 0.02; Difference between least squares means -0.07 (95% CI -0.14 to -0.01); ANCOVA NCT00535288 ↗

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.