Study summary

This study is for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman’s last period. Hot flashes can interrupt a woman’s daily life.

The study treatments are fezolinetant (1 tablet) once a day or placebo (1 tablet) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) The study will compare fezolinetant and placebo after 4 and 12 weeks of dosing. The study will see if fezolinetant reduces the number of hot flashes. And the study will see if fezolinetant reduces the severity of the hot flashes.

Women in the study will receive an electronic handheld device at the first study visit. (It is similar to a smart phone.) Each day of the study, study participants will use this to record their hot flashes. Their record for the 10 days before the start of study treatment will be checked. They can remain in the study if their record shows 7 or 8 moderate to severe hot flashes per day (50 or more per week).

Next, they will be picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It is like flipping a coin.

The study participants will take study treatment for 24 weeks. The first 12 weeks of study treatment are “double-blinded.” That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant or placebo) during that time. The last 12 weeks of study treatment are “noncontrolled.” That means that each study participant and the study doctors know which study treatment that study participant takes during that time. Women who take fezolinetant during the first 12 weeks will continue to take fezolinetant. Women who take placebo during the first 12 weeks will start taking fezolinetant.

At weeks 2, 4, 8, 12, 14, 16, 20 and 24, the study participants will go to the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. Study participants will complete questionnaires that are about how hot flashes affect their daily life. Study participants who still have their uterus will have the following 2 tests done at the first and last study visits if they meet the criteria. One of the 2 tests is endometrial biopsy.

This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. This test uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees.

The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.

Additional Study Details

Phase
Phase 3
Product
  • Fezolinetant
  • Placebo
  • Type
    Interventional
    Masking
    Double (Participant, Investigator)
    Enrollment number
    302
    Show Additional Study Details

    Study documents

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

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    Would you like more information about clinical trial sites that are recruiting participants for A study to find out if fezolinetant helps reduce moderate to severe hot flashes in women in Asia 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 CN86037
      Chengdu, China
      Completed
      Site CN86011
      Nanjing, China
      Completed
      Site CN86026
      Nanning, China
      Completed
      Site TW88609
      Tainan, Taiwan, Province of China
      Completed
      Site CN86022
      Changchun, China
      Completed
      Site CN86034
      Hangzhou, China
      Completed
      Site CN86023
      Taiyuan, China
      Completed
      Site CN86015
      Tianjin, China
      Completed
      Site CN86001
      Beijing, China
      Withdrawn
      Site TW88605
      Kaohsiung City, Taiwan, Province of China
      Completed
      Site CN86002
      Beijing, China
      Completed
      Site TW88611
      Taipei, Taiwan, Province of China
      Completed
      Site KR82004
      Seoul, Republic of Korea
      Completed
      Site KR82012
      Seoul, Republic of Korea
      Completed
      Site KR82003
      Seongnam-si, Republic of Korea
      Completed
      Site TW88608
      Kaohsiung City, Taiwan, Province of China
      Completed
      Site CN86025
      Hangzhou, China
      Completed
      Site CN86041
      Yangzhou, China
      Completed
      Site CN86013
      Yinchuan, China
      Completed
      Site KR82001
      Seoul, Republic of Korea
      Completed
      Site CN86029
      Tianjin, China
      Completed
      Site CN86043
      Guangzhou, China
      Withdrawn
      Site KR82007
      Seoul, Republic of Korea
      Completed
      Site CN86007
      Shijiazhuang, China
      Completed
      Site CN86006
      Guangzhou, China
      Withdrawn
      Site CN86038
      Suzhou, China
      Completed
      Site TW88601
      Taipei, Taiwan, Province of China
      Completed
      Site KR82006
      Seoul, Republic of Korea
      Completed
      Site CN86019
      Guangzhou, China
      Withdrawn
      Site KR82009
      Busan, Republic of Korea
      Completed
      Site CN86008
      Wuhan, China
      Completed
      Site KR82002
      Seoul, Republic of Korea
      Completed
      Site KR82013
      Ansan-si, Republic of Korea
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      Site CN86005
      Liuzhou, China
      Withdrawn
      Site CN86028
      Yangzhou, China
      Completed
      Site CN86033
      Zhongshan, China
      Completed
      Site KR82011
      Seongnam-si, Republic of Korea
      Completed
      Site TW88604
      New Taipei City, Taiwan, Province of China
      Completed
      Site CN86004
      Nanjing, China
      Completed
      Site KR82005
      Busan, Republic of Korea
      Completed
      Site TW88607
      Taipei, Taiwan, Province of China
      Withdrawn
      Site CN86020
      Lanzhou, China
      Completed
      Site CN86021
      Shenzhen, China
      Completed
      Site TW88606
      Taichung, Taiwan, Province of China
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      Site TW88603
      Tainan, Taiwan, Province of China
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      Site CN86009
      Changsha, China
      Withdrawn
      Site TW88602
      Tainan, Taiwan, Province of China
      Completed
      Site CN86012
      Shanghai, China
      Withdrawn
      Site CN86039
      Fuzhou, China
      Completed
      Site CN86027
      Kunming, China
      Completed
      Site CN86030
      Beijing, China
      Completed
      Site CN86042
      Guangzhou, China
      Completed
      Site CN86031
      Taiyuan, China
      Completed
      Site CN86018
      Guiyang, China
      Withdrawn
      Site CN86032
      Nanning, China
      Completed
      Site CN86035
      Nanjing, China
      Withdrawn
      Site CN86040
      Dalian, China
      Completed
      Site CN86017
      Beijing, China
      Withdrawn
      Site CN86016
      Tianjin, China
      Withdrawn
      Site TW88610
      Putzu, Taiwan, Province of China

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