A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
Status:
Not yet recruiting
Trial end date:
2023-05-30
Target enrollment:
Participant gender:
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).