Study summary

Hot flashes are the most common reason women going through menopause seek medical attention. Hormone replacement therapy, or HRT, is most often prescribed to treat hot flashes. However, HRT can’t be used by all women or for as long as may be needed.

Researchers want to find other ways to treat hot flashes. Fezolinetant is a medicine to treat hot flashes in women going through menopause. Fezolinetant is an approved medicine in the US. Further studies are needed before it is available in other regions such as Asia.

In this study fezolinetant will be used to treat hot flashes in Japanese women going through menopause. This study will confirm the safety of fezolinetant and how well the women tolerate the treatment.

Women will either take fezolinetant or a placebo. This is decided by chance alone. The placebo looks like fezolinetant but will not have any medicine in it.

The women will take 1 tablet of the study medicine (fezolinetant or the placebo) once a day for up to 52 weeks.

During the study, the women will visit their study clinic for a check-up about every 4 weeks for up to 52 weeks (1 year). At each visit they will be asked if they had any medical problems. Other checks will include a medical examination and vital signs (temperature, blood pressure and pulse). At some visits, the women will have an ECG to check their heart rhythm and some blood and urine samples will be taken for laboratory tests. During a couple of visits, women who have a womb (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 clinic visit will be 3 weeks after the women take their final tablet of the study medicine (fezolinetant or the placebo).

Additional Study Details

Phase
Phase 3
Product
  • Fezolinetant
  • Placebo
  • Type
    Interventional
    Masking
    Triple (Participant, Investigator, Outcomes Assessor)
    Enrollment number
    277
    Show Additional Study Details

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    Would you like more information about clinical trial sites that are recruiting participants for A study to assess long-term safety of fezolinetant given to Japanese 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

      Contact Us
      Contact Us
      Active, not recruiting
      NISHIKAWA Women's Health Clinic
      Sapporo-shi, Hokkaido, Japan
      Active, not recruiting
      Medical Corporation Asbo Tokyo Asbo Clinic
      Chuo-ku, Tokyo, Japan
      Active, not recruiting
      Kotoni Ladies Clinic
      Sapporo-shi, Hokkaido, Japan
      Active, not recruiting
      Mori Ladies Clinic
      Fukuoka-shi, Fukuoka, Japan
      Active, not recruiting
      Daido Clinic
      Nagoya-shi, Aichi, Japan
      Active, not recruiting
      Medical Corp.SEIKOUKAI New Medical Research System Clinic
      Hachioji-shi, Tokyo, Japan
      Active, not recruiting
      Medical Corporation Associa Tamacenter Ladies Clinic
      Tama-Shi, Tokyo, Japan
      Active, not recruiting
      jMOG Medical Corporation Tanabe Ladies’ Clinic
      Takatsuki-shi, Osaka, Japan
      Active, not recruiting
      GyNet Medical Corporation Minamimorimachi Ladies’ Clinic
      Osaka-shi, Osaka, Japan
      Active, not recruiting
      Shimodaira Ladies Clinic
      Suginami-ku, Tokyo, Japan
      Active, not recruiting
      Chieko Yukika Lady's Clinic
      Sendai-shi, Miyagi, Japan
      Active, not recruiting
      Kichijyoji Ladies Clinic
      Musashino-shi, Tokyo, Japan
      Active, not recruiting
      YUKAWA WOMEN'S CLINIC
      Nishitokyo-shi, Tokyo, Japan
      Active, not recruiting
      Shimamura Memorial Hospital
      Nerima-ku, Tokyo, Japan
      Active, not recruiting
      Juno Vesta Clinic hatta
      Matsudo-shi, Chiba, Japan
      Active, not recruiting
      Women's Clinic LUNA Yokohama Motomachi
      Yokohama-shi, Kanagawa, Japan
      Active, not recruiting
      Shimizu Ladies Clinic
      Sakai-shi, Osaka, Japan
      Active, not recruiting
      Rikako Ladies Clinic
      Osaka-shi, Osaka, Japan
      Active, not recruiting
      Marunouchi no Mori Ladies Clinic
      Chiyoda-ku, Tokyo, Japan
      Active, not recruiting
      Ninomiya Ladies Clinic
      Osaka City, Osaka, Japan
      Active, not recruiting
      Tennoji Chihiro Women’s Clinic
      Osaka-shi, Osaka, Japan
      Active, not recruiting
      Ginza Yoshida Medical Clinic
      Chuo-ku, Tokyo, Japan
      Active, not recruiting
      M's Ladies Clinic
      Sapporo-shi, Hokkaido, Japan
      Active, not recruiting
      Motomachi Ladies Clinic
      Yokohama-shi, Kanagawa, Japan

      Frequently Asked Questions

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