Hot flashes are the most common reason women going through menopause seek medical attention. Hormone replacement therapy, or HRT, is most often prescribed to treat hot flashes. However, HRT can't be used by all women or for as long as may be needed. Researchers want to find other ways to treat hot flashes. Fezolinetant is a medicine to treat hot flashes in women going through menopause. Fezolinetant is an approved medicine in the US. Further studies are needed before it is available in other regions such as Asia. In this study fezolinetant will be used to treat hot flashes in Japanese women going through menopause. This study will confirm the safety of fezolinetant and how well the women tolerate the treatment. Women will either take fezolinetant or a placebo. This is decided by chance alone. The placebo looks like fezolinetant but will not have any medicine in it. The women will take 1 tablet of the study medicine (fezolinetant or the placebo) once a day for up to 52 weeks. During the study, the women will visit their study clinic for a check-up about every 4 weeks for up to 52 weeks (1 year). At each visit they will be asked if they had any medical problems. Other checks will include a medical examination and vital signs (temperature, blood pressure and pulse). At some visits, the women will have an ECG to check their heart rhythm and some blood and urine samples will be taken for laboratory tests. During a couple of visits, women who have a womb (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 clinic visit will be 3 weeks after the women take their final tablet of the study medicine (fezolinetant or the placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
277
oral
oral
Daido Clinic
Nagoya, Aichi-ken, Japan
Juno Vesta Clinic hatta
Matsudo-shi, Chiba, Japan
Mori Ladies Clinic
Fukuoka, Fukuoka, Japan
Kotoni Ladies Clinic
Sapporo, Hokkaido, Japan
M's Ladies Clinic
Sapporo, Hokkaido, Japan
NISHIKAWA Women's Health Clinic
Sapporo, Hokkaido, Japan
Motomachi Ladies Clinic
Yokohama, Kanagawa, Japan
Women's Clinic LUNA Yokohama Motomachi
Yokohama, Kanagawa, Japan
Chieko Yukika Lady's Clinic
Sendai, Miyagi, Japan
GyNet Medical Corporation Minamimorimachi Ladies' Clinic
Osaka, Osaka, Japan
...and 14 more locations
Number of participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Time frame: Up to Week 55
Change from baseline in endometrial thickness in post-menopausal participants
Endometrial thickness is a measure of how thick the lining of the uterus is. Endometrial thickness will be measured by transvaginal ultrasound (TVU).
Time frame: Baseline and up to Week 52
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to Week 55
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to Week 55
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Time frame: Up to Week 52
Pharmacokinetics (PK) of fezolinetant in plasma: Concentration
Concentration will be recorded from the PK plasma samples collected.
Time frame: Up to Week 52
Pharmacokinetics (PK) of metabolite ES259564 in plasma: Concentration
Concentration will be recorded from the PK plasma samples collected.
Time frame: Up to Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.