A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
Condition: Vasomotor Symptoms
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is for women in menopause who have moderate to severe hot flashes. It is for women
      who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is
      the time after a woman's last period. Hot flashes often occur during menopause. They can
      disrupt a woman's daily life.

      The study medicines (also called investigational products, or IP) are tablets of fezolinetant
      or placebo. An investigational product means that the product is not yet licensed. In this
      study, a placebo is a dummy treatment that looks like fezolinetant but does not have any
      medicine in it. The study will compare fezolinetant with the placebo to learn if fezolinetant
      reduces the number and severity of hot flashes.

      Women that want to take part in the study will be given an electronic handheld device with an
      app to track their hot flashes. Some women may be able to use the app on their own
      smartphone. In the last 10 days before their next clinic visit, the women will record
      information about their hot flashes. They can take part in the study if they have an average
      of 7 or more moderate to severe hot flashes each day. Women will be picked for 1 of 2
      treatments (fezolinetant or placebo) by chance alone.

      Women who take part in the study will take 2 tablets every day for 24 weeks. Treatment will
      be double-blinded. That means that the women in the study and the study doctors will not know
      who takes which of the study medicines (fezolinetant or placebo). The women will continue
      recording information about their hot flashes on the electronic device or their phone. They
      will also use another device to answer questions about how hot flashes affect their daily
      life.

      During the study, the women will visit their study clinic several times for a check-up. This
      will happen during Weeks 2, 4, 8, 12, 16, 20, 24, and 27. Some women may be able to have home
      visits instead, from Week 2 to Week 20. At the check-up, they will be asked if they have any
      medical problems. Other checks will include vital signs (heart rate, temperature and blood
      pressure) and some blood samples taken for laboratory tests. At some check-ups, the women
      will have a physical exam. In Week 2 and Week 24, the women will have an ECG to check their
      heart rhythm. Women who have a 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 check-up (at Week 27) will be 3 weeks after they take their last tablets of study
      medicine (fezolinetant or placebo).
    


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