Hot flashes are sudden feelings of warmth, which are usually most intense over the face, neck and chest. Your skin might redden, as if you're blushing. Hot flashes can also cause sweating, and if you lose too much body heat, you might feel chilled afterward. Although other medical conditions can cause them, hot flashes most commonly are due to menopause — the time when menstrual periods become irregular and eventually stop. In fact, hot flashes are the most common symptom of the menopausal transition.
- This study is for women in menopause with 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 purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the “adverse events.” Those are the side effects that study participants have while they are in the study.
- 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.)
- Women in this study will be picked for 1 of the 3 study treatments by chance alone. The study participants will take study treatment for 52 weeks.
- This study is “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).
- Women between the ages of 40 – 65 years old
- Experiencing moderate to severe hot flashes
If Qualified & you Participate you will Receive;
- Study Medication
- Study-related physical exams and lab tests
- Compensation for time and travel