A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)

NCT03192176 ↗

Phase 2 Completed 356 enrolled Astellas Pharma Global Development, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.

Timeline

Start: 2017-07-19
Primary completion: 2018-09-19
Completion: 2018-09-19

Publications

Fraser GL, Lederman S, Waldbaum A, Kroll R, Santoro N, Lee M, Skillern L, Ramael S. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause. 2020 Apr;27(4):382-392. doi: 10.1097/GME.0000000000001510.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fezolinetant	Small molecule	15 mg	Oral
Subject	Fezolinetant	Small molecule	30 mg	Oral
Subject	Fezolinetant	Small molecule	60 mg	Oral
Subject	Fezolinetant	Small molecule	90 mg	Oral
Subject	Fezolinetant	Small molecule	120 mg	Oral

Indications

No indication recorded.