A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This study will consist of a screening period and a 24-week treatment period. Safety follow
      up will occur 3 weeks after the last dose of study drug.
    

Intervention name(s): Fezolinetant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): ESN364
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ESN364; menopause; fezolinetant; vasomotor symptoms