Study Details

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A study to find out if fezolinetant helps reduce moderate to severe hot flashes in women in Asia going through menopause

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT04234204

Astellas Study ID

The unique identification code given by the study sponsor.

2693-CL-0305

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

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Condition

Hot Flashes

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

40 Years - 65 Years

Sex

Female

Product

fezolinetant

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Mar 2020 - Apr 2022

Masking

Double (Participant, Investigator)

Enrollment number

302

A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women in Asia Suffering from Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated with Menopause

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site CN86037

Chengdu, China

Site CN86011

Nanjing, China

Site CN86026

Nanning, China

Site TW88609

Tainan, Taiwan, Province of China

Site CN86022

Changchun, China

Site CN86034

Hangzhou, China

Site CN86023

Taiyuan, China

Site CN86015

Tianjin, China

Site CN86001

Beijing, China

Site TW88605

Kaohsiung City, Taiwan, Province of China

Site CN86002

Beijing, China

Site TW88611

Taipei, Taiwan, Province of China

Site KR82004

Seoul, Republic of Korea

Site KR82012

Seoul, Republic of Korea

Site KR82003

Seongnam-si, Republic of Korea

Site TW88608

Kaohsiung City, Taiwan, Province of China

Site CN86025

Hangzhou, China

Site CN86041

Yangzhou, China

Site CN86013

Yinchuan, China

Site KR82001

Seoul, Republic of Korea

Site CN86029

Tianjin, China

Site CN86043

Guangzhou, China

Site KR82007

Seoul, Republic of Korea

Site CN86007

Shijiazhuang, China

Site CN86006

Guangzhou, China

Site CN86038

Suzhou, China

Site TW88601

Taipei, Taiwan, Province of China

Site KR82006

Seoul, Republic of Korea

Site CN86019

Guangzhou, China

Site KR82009

Busan, Republic of Korea

Site CN86008

Wuhan, China

Site KR82002

Seoul, Republic of Korea

Site KR82013

Ansan-si, Republic of Korea

Site CN86005

Liuzhou, China

Site CN86028

Yangzhou, China

Site CN86033

Zhongshan, China

Site KR82011

Seongnam-si, Republic of Korea

Site TW88604

New Taipei City, Taiwan, Province of China

Site CN86004

Nanjing, China

Site KR82005

Busan, Republic of Korea

Site TW88607

Taipei, Taiwan, Province of China

Site CN86020

Lanzhou, China

Site CN86021

Shenzhen, China

Site TW88606

Taichung, Taiwan, Province of China

Site TW88603

Tainan, Taiwan, Province of China

Site CN86009

Changsha, China

Site TW88602

Tainan, Taiwan, Province of China

Site CN86012

Shanghai, China

Site CN86039

Fuzhou, China

Site CN86027

Kunming, China

Site CN86030

Beijing, China

Site CN86042

Guangzhou, China

Site CN86031

Taiyuan, China

Site CN86018

Guiyang, China

Site CN86032

Nanning, China

Site CN86035

Nanjing, China

Site CN86040

Dalian, China

Site CN86017

Beijing, China

Site CN86016

Tianjin, China

Site TW88610

Putzu, Taiwan, Province of China

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