A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
Status:
Not yet recruiting
Trial end date:
2022-12-21
Target enrollment:
Participant gender:
Summary
This study is for menopausal women who have hot flashes. 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. This study will take place in Japan.
This study will provide more information on a potential new treatment, called fezolinetant.
The treatments in this study are fezolinetant or a placebo. 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 find the best dose of fezolinetant to reduce
the number and severity of hot flashes.
Women that want to take part in the study will be given an electronic handheld device to
track their hot flashes. In the last 10 days before their next clinic visit, the women will
record information about their hot flashes. Women will be picked for 1 of 3 treatments (lower
or higher dose of fezolinetant, or placebo) by chance alone.
Women who take part in the study will take 2 tablets every day for 12 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 (lower or higher dose of fezolinetant, or placebo).
The women will continue recording information about their hot flashes on the electronic
device. 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 and 15. At the check-up, they will be asked if they have
any medical problems. Other checks will include some blood samples taken for laboratory
tests. At some check-ups, the women will have a physical exam, an ECG to check their heart
rhythm, and their vital signs checked (pulse rate, temperature and blood pressure). At the
first visit and in week 15, 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 15) will be 3 weeks after they take their last tablets of study
medicine (lower or higher dose of fezolinetant or placebo).