A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was 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 30 mg (1 tablet of fezolinetant and 1 placebo tablet)
      once a day, fezolinetant 45 mg (2 tablets of fezolinetant) once a day or placebo (2 tablets)
      once a day. (Placebo is a dummy treatment that looks like medicine but does not have any
      medicine in it.) The study compared fezolinetant and placebo after 4 and 12 weeks of dosing.
      The study evaluated if fezolinetant reduces the number of hot flashes and the study evaluated
      if fezolinetant reduces the severity of the hot flashes.

      Women in the study received an electronic handheld device at the first study visit. (It is
      similar to a smart phone.) Each day of the study, study participants used this to record
      their hot flashes. Their record for the 10 days before the start of study treatment was
      checked. They remained in the study if their record shows 7 or 8 moderate to severe hot
      flashes per day (50 or more per week). Next, they were picked for 1 of the 2 study treatments
      (fezolinetant or placebo) by chance alone. It is like flipping a coin.

      The study participants took study treatment for 52 weeks. The first 12 weeks of study
      treatment was "double-blinded." That means that the study participants and the study doctors
      did not know who took which of the study treatments (fezolinetant 30 mg, fezolinetant 45 mg
      or placebo) during that time. The last 40 weeks of study treatment was "noncontrolled." That
      means that each study participant and the study doctors knew which study treatment that study
      participant took during that time. Women who took fezolinetant during the first 12 weeks
      continued to take the same dose. Women who took placebo during the first 12 weeks took
      fezolinetant. Their dose was either 30 mg or 45 mg fezolinetant.

      At weeks 2, 4, 8, 12, 14, 16 and then once a month, the study participants went to the
      hospital or clinic for a check-up. They were asked about medications, side effects and how
      they felt. Other checks included physical exam and vital signs (heart rate, temperature and
      blood pressure). Blood and urine was collected for laboratory tests. Study participants
      completed questionnaires that were about how hot flashes affect their daily life. Study
      participants who had their uterus had the following 2 tests done at the first and last study
      visits. One of the 2 tests was endometrial biopsy. This test involved removing a small amount
      of tissue from the inside lining of the uterus. The tissue was then checked under a
      microscope. The other test was transvaginal ultrasound. This test used sound waves to create
      pictures of the organs in the pelvis. The sound waves are transmitted by a probe
      (transducer), which was placed inside the vagina. Study participants might 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 had it done at the first study visit. They had done at the last study
      visit if they were due for their screening mammogram and their own doctor agrees.

      The last check-up at the hospital or clinic was 3 weeks after the last dose of study
      treatment.
    

Detailed description: 
      This study consisted of a screening period and a 52 week treatment period. Safety follow up
      occurred 3 weeks after the last dose of study drug.
    

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