A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause
Status:
Completed
Trial end date:
2021-08-11
Target enrollment:
Participant gender:
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 low dose (1 tablet of fezolinetant and 1 placebo
tablet) once a day, fezolinetant high dose (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 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 52 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 low dose, fezolinetant high
dose or placebo) during that time. The last 40 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 the same dose. Women who take placebo during the first 12 weeks
will start taking fezolinetant. Their dose will be either low dose or high dose fezolinetant.
At weeks 2, 4, 8, 12, 14, 16 and then once a month, 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. 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.