Study summary

This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman’s last period. Hot flashes often occur during menopause. They can disrupt a woman’s daily life.

The study medicines (also called investigational products, or IP) are tablets of fezolinetant or placebo. An investigational product means that the product is not yet licensed. In this study, a placebo is a dummy treatment that looks like fezolinetant but does not have any medicine in it. The study will compare fezolinetant with the placebo to learn if fezolinetant reduces the number and severity of hot flashes.

Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. Women will be picked for 1 of 2 treatments (fezolinetant or placebo) by chance alone.

Women who take part in the study will take 2 tablets every day for 24 weeks. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study medicines (fezolinetant or placebo). The women will continue recording information about their hot flashes on the electronic device or their phone. They will also use another device to answer questions about how hot flashes affect their daily life.

During the study, the women will visit their study clinic several times for a check-up. This will happen during Weeks 2, 4, 8, 12, 16, 20, 24, and 27. Some women may be able to have home visits instead, from Week 2 to Week 20. At the check-up, they will be asked if they have any medical problems. Other checks will include vital signs (heart rate, temperature and blood pressure) and some blood samples taken for laboratory tests. At some check-ups, the women will have a physical exam. In Week 2 and Week 24, the women will have an ECG to check their heart rhythm. Women who have a uterus will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs.

The last check-up (at Week 27) will be 3 weeks after they take their last tablets of study medicine (fezolinetant or placebo).

Additional Study Details

Phase
Phase 3
Product
  • fezolinetant
  • placebo
  • Type
    Interventional
    Masking
    Double (Participant, Investigator)
    Enrollment number
    453
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for A study of fezolinetant to treat hot flashes in women going through menopause? Contact us by filling out your information to the right and we’ll respond to you.

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      Locations

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      Completed
      Site CA15008
      Brampton, Ontario, Canada, L6T 0G1
      Completed
      Site CA15009
      Quebec, Quebec, Canada, G1S 2L6
      Completed
      Site CA15003
      Sarnia, Ontario, Canada, N7T 4X3
      Completed
      Site CA15002
      Quebec, Quebec, Canada, G1S 2L6
      Completed
      Site CA15014
      Quebec City, Quebec, Canada, G3K 2P8
      Completed
      Site CA15010
      London, Ontario, Canada, N5W 6A2
      Withdrawn
      Site CA15006
      Toronto, Ontario, Canada, M4S 1Y2
      Completed
      Site HU36004
      Kecskemet, Hungary, 6000
      Completed
      Site HU36001
      Szekesfeherver, Hungary, 8000
      Completed
      Site CA15007
      Quebec, Quebec, Canada, G1W 4R4
      Completed
      Site CA15005
      Victoriaville, Quebec, Canada, G6P 6P6
      Completed
      Site CA15001
      Sherbrooke, Quebec, Canada, J1L 0H8
      Completed
      Site CA15011
      Saint Charles Borromeee, Quebec, Canada, J6E 2B4
      Completed
      Site HU36002
      Debrecen, Hungary, 4024
      Completed
      Site CA15012
      Montreal, Quebec, Canada, H1M 1B1
      Completed
      Site ES34005
      Centellas, Spain, 8540
      Withdrawn
      Site CA15013
      Kamloops, British Columbia, Canada, V2C 5T1
      Completed
      Site ES34001
      Madrid, Spain, 28041
      Completed
      Site ES34003
      Leganes, Spain, 28915
      Completed
      Site ES34002
      Alcobendas, Spain, 28100
      Withdrawn
      Site PL48002
      Lublin, Poland, 20-880
      Completed
      Site PL48004
      Katowice, Poland, 40-301
      Completed
      Site PL48009
      Siedice, Poland, 08-110
      Completed
      Site PL48001
      Szczecin, ZACHODNIOPOMORSKIE, Poland, 71-434
      Completed
      Site PL48003
      Bialystok, Poland, 15-224
      Completed
      Site PL48011
      Katowice, Poland, 40-156
      Completed
      Site CZ42010
      Ceske Budejovice, Czech Republic, 37001
      Completed
      Site CZ42003
      Olomouc, Czech Republic, 772 00
      Completed
      Site CZ42004
      Pisek, Czech Republic, 397 01
      Completed
      Site CZ42008
      Brno, Czech Republic, 603 00
      Completed
      Site CZ42002
      Vodnany, Jihocesky, Czech Republic, 389 01
      Completed
      Site CZ42006
      Praha 2, Czech Republic, 120 00
      Completed
      Site CZ42007
      Tabor 3, Jihocesky, Czech Republic, 39003
      Completed
      Site PL48007
      Lublin, Poland, 20-064
      Completed
      Site PL48013
      Bydgoszcz, Poland, 85-048
      Completed
      Site PL48010
      Zamosc, Poland, 22 400
      Withdrawn
      Site CZ42001
      Vsetin, Czech Republic, 755 01
      Completed
      Site CZ42011
      Nachod, Czech Republic, 54701
      Withdrawn
      Site PL48005
      Warszawa, Poland, 02-793
      Completed
      Site PL48006
      Katowice, Poland, 40-065
      Completed
      Site CZ42009
      Hradec Kralove, Czech Republic, 500 02
      Withdrawn
      Site HU36003
      Budapest, Hungary, 1134
      Completed
      Site PL48017
      Skierniewice, Poland, 96-100
      Completed
      Site NL31004
      Rotterdam, Netherlands, 3051 GV
      Completed
      Site SE46004
      Qerebro, Sweden, 435 33
      Completed
      Site SE46002
      Uppsala, Sweden, 435 33
      Completed
      Site GB44002
      Coventry, United Kingdom, CV3 4FJ
      Completed
      Site GB44004
      Shipley, Yorkshire, United Kingdom, BD18 3SA
      Completed
      Site CZ42005
      Cheb, Czech Republic, 350 02
      Completed
      Site PL48012
      Skorzewo, Poland, 60185
      Completed
      Site GB44007
      Corby, Northamptonshire, United Kingdom, NN18 9EZ
      Completed
      Site GB44006
      Northwood, United Kingdom, HA6 2RN
      Withdrawn
      Site NL31002
      Almere, Netherlands, 1311RL
      Completed
      Site GB44003
      Orpington, United Kingdom, BR5 3QG
      Completed
      Site DK45003
      Gandrup, Nordjylland, Denmark, 9362
      Completed
      Site BE32005
      Tienen, Vlaams Brabant, Belgium, 3300
      Completed
      Site NO47001
      Hamar, Norway, 2317
      Completed
      Site IT39006
      Pavia, Italy, 27100
      Completed
      Site DE49005
      Hamburg, Germany, 22159
      Completed
      Site FR33001
      Nantes, France, 44093
      Withdrawn
      Site SE46001
      Malmo, Sweden, 211 52
      Completed
      Site SE46003
      Stockholm, Sweden, 17176
      Withdrawn
      Site BE32004
      Bruxelles, Belgium, 1200
      Completed
      Site TR90002
      Konak, Izmir, Turkey, 35020
      Completed
      Site DK45004
      Vejle, Syddanmark, Denmark, 7100
      Withdrawn
      Site ES34006
      Oviedo, Spain, 33011
      Withdrawn
      Site BE32001
      Genk, Belgium, 3600
      Withdrawn
      Site BE32002
      Bruxelles, Belgium, 1000
      Completed
      Site NL31001
      Beek, Limburg, Netherlands, 6191 JW
      Completed
      Site DE49004
      Hamburg, Germany, 20253
      Withdrawn
      Site IT39005
      Udine, Italy, 33100
      Withdrawn
      Site IT39004
      Pisa, Italy, 56126
      Completed
      Site DE49002
      Leipzig, Germany, 10026
      Completed
      Site DE49006
      Schwerin, Germany, 19055
      Withdrawn
      Site NO47002
      Oslo, Norway, 12085
      Completed
      Site IT39002
      Bologna, Italy, 12081
      Completed
      Site FI35801
      Kuopio, Finland, 02200
      Withdrawn
      Site ES34007
      Barakaldo, Spain, 48903
      Withdrawn
      Site TR90007
      Istanbul, Turkey, 34093
      Withdrawn
      Site DE49007
      Geseke, Germany, 59494
      Withdrawn
      Site TR90003
      Bursa, Turkey, 16059
      Completed
      Site FI35803
      Oulu, Oulu, Finland, 02200
      Completed
      Site DE49008
      Muechen, Germany, 12092
      Completed
      Site FR33003
      La Rochelle, France, 17000
      Completed
      Site TR90008
      Izmir, Turkey, 35100
      Completed
      Site TR90001
      Ankara, Mamak, Turkey, 06620
      Withdrawn
      Site FR33002
      Poitiers, France, 86000
      Withdrawn
      Site BE32003
      Gent, Belgium, 9000
      Completed
      Site DK45005
      Arhus C, Denmark, 8000
      Withdrawn
      Site DE49001
      Berlin, Germany, 10627
      Completed
      Site DK45002
      Odense, Syddanmark, Denmark, 5000
      Withdrawn
      Site DE49003
      Muenchen, Germany, 81675
      Withdrawn
      Site TR90005
      Ankara, Turkey, 06010
      Withdrawn
      Site ES34004
      Madrid, Spain, 28050

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