NCT03291067

MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women

A Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of MT-8554 on the Frequency and Severity of Vasomotor Symptoms in Postmenopausal Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Tanabe Pharma America, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.

Detailed description

This is a Phase II randomized, double-blind, placebo-controlled study for dose selection in postmenopausal women with moderate to severe VMS, defined as follows: * Moderate: sensation of heat with sweating, able to continue activity * Severe: sensation of heat with sweating, causing cessation of activity This study is comprised of a screening period, a run-in period and a 12-week double-blind treatment period.

Conditions

• Menopause Hot Flashes

Interventions

Type	Name	Description
DRUG	MT-8554 1mg	MT-8554 1mg QD, oral, 12 weeks
DRUG	MT-8554 5mg	MT-8554 5mg QD, oral, 12 weeks
DRUG	MT-8554 10mg	MT-8554 10mg QD, oral, 12 weeks
DRUG	Placebo	Placebo QD, oral, 12 weeks

Timeline

• Start date: 2017-10-09
• Primary completion: 2018-10-19
• Completion: 2018-11-09
• First posted: 2017-09-25
• Last updated: 2026-01-23
• Results posted: 2022-01-04

Locations

63 sites across 1 country: United States

Regulatory

• FDA-regulated drug study