Study Details

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A study of fezolinetant to treat hot flashes in women 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.
NCT05033886

Astellas Study ID

The unique identification code given by the study sponsor.

2693-CL-0312

EudraCT ID

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

2021-001685-38

Follow Trial

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

Oct 2021 - Apr 2023

Masking

Double (Participant, Investigator)

Enrollment number

453

A Phase 3b, Randomized, Double-blind, Placebo-controlled, 24-week Study to Assess the Efficacy and Safety of Fezolinetant in Menopausal Women Suffering from Moderate to Severe Vasomotor Symptoms (Hot Flashes) and Considered Unsuitable for Hormone Replacement Therapy

Study summary

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Locations

Site CA15008

Brampton, Canada, L6T 0G1

Site CA15009

Quebec, Canada, G1S 2L6

Site CA15003

Sarnia, Canada, N7T 4X3

Site CA15002

Quebec, Canada, G1S 2L6

Site CA15014

Quebec City, Canada, G3K 2P8

Site CA15010

London, Canada, N5W 6A2

Site CA15006

Toronto, Canada, M4S 1Y2

Site HU36004

Kecskemet, Hungary, 6000

Site HU36001

Szekesfeherver, Hungary, 8000

Site CA15007

Quebec, Canada, G1W 4R4

Site CA15005

Victoriaville, Canada, G6P 6P6

Site CA15001

Sherbrooke, Canada, J1L 0H8

Site CA15011

Saint Charles Borromeee, Canada, J6E 2B4

Site HU36002

Debrecen, Hungary, 4024

Site CA15012

Montreal, Canada, H1M 1B1

Site ES34005

Centellas, Spain, 8540

Site CA15013

Kamloops, Canada, V2C 5T1

Site ES34001

Madrid, Spain, 28041

Site ES34003

Leganes, Spain, 28915

Site ES34002

Alcobendas, Spain, 28100

Site PL48002

Lublin, Poland, 20-880

Site PL48004

Katowice, Poland, 40-301

Site PL48009

Siedice, Poland, 08-110

Site PL48001

Szczecin, Poland, 71-434

Site PL48003

Bialystok, Poland, 15-224

Site PL48011

Katowice, Poland, 40-156

Site CZ42010

Ceske Budejovice, Czech Republic, 37001

Site CZ42003

Olomouc, Czech Republic, 772 00

Site CZ42004

Pisek, Czech Republic, 397 01

Site CZ42008

Brno, Czech Republic, 603 00

Site CZ42002

Vodnany, Czech Republic, 389 01

Site CZ42006

Praha 2, Czech Republic, 120 00

Site CZ42007

Tabor 3, Czech Republic, 39003

Site PL48007

Lublin, Poland, 20-064

Site PL48013

Bydgoszcz, Poland, 85-048

Site PL48010

Zamosc, Poland, 22 400

Site CZ42001

Vsetin, Czech Republic, 755 01

Site CZ42011

Nachod, Czech Republic, 54701

Site PL48005

Warszawa, Poland, 02-793

Site PL48006

Katowice, Poland, 40-065

Site CZ42009

Hradec Kralove, Czech Republic, 500 02

Site HU36003

Budapest, Hungary, 1134

Site PL48017

Skierniewice, Poland, 96-100

Site NL31004

Rotterdam, Netherlands, 3051 GV

Site SE46004

Qerebro, Sweden, 435 33

Site SE46002

Uppsala, Sweden, 435 33

Site GB44002

Coventry, United Kingdom, CV3 4FJ

Site GB44004

Shipley, United Kingdom, BD18 3SA

Site CZ42005

Cheb, Czech Republic, 350 02

Site PL48012

Skorzewo, Poland, 60185

Site GB44007

Corby, United Kingdom, NN18 9EZ

Site GB44006

Northwood, United Kingdom, HA6 2RN

Site NL31002

Almere, Netherlands, 1311RL

Site GB44003

Orpington, United Kingdom, BR5 3QG

Site DK45003

Gandrup, Denmark, 9362

Site BE32005

Tienen, Belgium, 3300

Site NO47001

Hamar, Norway, 2317

Site IT39006

Pavia, Italy, 27100

Site DE49005

Hamburg, Germany, 22159

Site FR33001

Nantes, France, 44093

Site SE46001

Malmo, Sweden, 211 52

Site SE46003

Stockholm, Sweden, 17176

Site BE32004

Bruxelles, Belgium, 1200

Site TR90002

Konak, Turkey, 35020

Site DK45004

Vejle, Denmark, 7100

Site ES34006

Oviedo, Spain, 33011

Site BE32001

Genk, Belgium, 3600

Site BE32002

Bruxelles, Belgium, 1000

Site NL31001

Beek, Netherlands, 6191 JW

Site DE49004

Hamburg, Germany, 20253

Site IT39005

Udine, Italy, 33100

Site IT39004

Pisa, Italy, 56126

Site DE49002

Leipzig, Germany, 10026

Site DE49006

Schwerin, Germany, 19055

Site NO47002

Oslo, Norway, 12085

Site IT39002

Bologna, Italy, 12081

Site FI35801

Kuopio, Finland, 02200

Site ES34007

Barakaldo, Spain, 48903

Site TR90007

Istanbul, Turkey, 34093

Site DE49007

Geseke, Germany, 59494

Site TR90003

Bursa, Turkey, 16059

Site FI35803

Oulu, Finland, 02200

Site DE49008

Muechen, Germany, 12092

Site FR33003

La Rochelle, France, 17000

Site TR90008

Izmir, Turkey, 35100

Site TR90001

Ankara, Turkey, 06620

Site FR33002

Poitiers, France, 86000

Site BE32003

Gent, Belgium, 9000

Site DK45005

Arhus C, Denmark, 8000

Site DE49001

Berlin, Germany, 10627

Site DK45002

Odense, Denmark, 5000

Site DE49003

Muenchen, Germany, 81675

Site TR90005

Ankara, Turkey, 06010

Site ES34004

Madrid, Spain, 28050

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