Study summary

This study is for women in menopause with 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 purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the “adverse events.” Those are the side effects that study participants have while they are in the study. The study treatment is fezolinetant (1 tablet of fezolinetant) once a day. The study participants will take study treatment for 52 weeks. At weeks 2 and 4 and then once a month, the study participants will go 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. At some study visits, study participants will complete questionnaires that are about their quality of life. Study participants who still have their uterus will have 2 more tests done at the first and last study visits. 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. It 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
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    150
    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 to Assess the Safety and Tolerability of Fezolinetant in Women Seeking Treatment for Relief of Vasomotor Symptoms (VMS) Associated With 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 CN86020
      Kunming, China
      Completed
      Site CN86012
      Hangzhou, China
      Completed
      Site CN86004
      Shenzhen, China
      Withdrawn
      Site CN86024
      Fuzhou, China
      Completed
      Site CN86015
      Beijing, China
      Completed
      Site CN86032
      Chengdu, China
      Completed
      Site CN86025
      Wuhan, China
      Completed
      Site CN86042
      Guangzhou, China
      Completed
      Site CN86022
      Guangzhou, China
      Completed
      Site CN86005
      Hunan, China
      Completed
      Site CN86009
      Shanghai, China
      Completed
      Site CN86011
      Shanxi, China
      Withdrawn
      Site CN86014
      Jiangsu, China
      Completed
      Site CN86007
      Nanjing, China
      Completed
      Site CN86002
      Beijing, China
      Completed
      Site CN86037
      Liuzhou, China
      Completed
      Site CN86030
      Tianjin, China
      Completed
      Site CN86001
      Guangzhou, China
      Completed
      Site CN86006
      Nanjing, China
      Completed
      Site CN86026
      Suzhou, China
      Completed
      Site CN86018
      Nanning, China
      Completed
      Site CN86036
      Tianjin, China
      Completed
      Site CN86008
      Hangzhou, China
      Completed
      Site CN86010
      Jinlin, China
      Completed
      Site CN86029
      Beijing, China
      Completed
      Site CN86019
      Guangzhou, China
      Completed
      Site CN86028
      Shijiazhuang, China
      Withdrawn
      Site CN86027
      Lanzhou, China
      Completed
      Site CN86039
      Jiangsu, China
      Completed
      Site CN86034
      Ningxia Hui Nationality Autonomous Region, China
      Withdrawn
      Site CN86013
      Guangxi, China
      Completed
      Site CN86038
      Taiyuan, China
      Completed
      Site CN86040
      Guangzhou, China
      Withdrawn
      Site CN86023
      Guizhou, China

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