A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant in Japanese Women Experiencing Vasomotor Symptoms (Hot Flashes) Associated With Menopause

Status: Active_not_recruiting
Location: See all (64) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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. This study will confirm if fezolintant helps reduce the number of hot flashes in Japanese women going through menopause. 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. Before the women are assigned a treatment, they will record information about their hot flashes. Women will either take a lower or higher dose of 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 2 tablets of the study medicine (lower or higher dose of fezolinetant, or the placebo) once a day for up to 12 weeks. They will either take 1 tablet of fezolinetant (higher or lower dose) and 1 placebo tablet, or they will take 2 placebo tablets. The women will continue to record information about their hot flashes on the electronic device or their smartphone. During the study, the women will visit the study clinic a few times. At each visit they will be asked if they had any medical problems and will use an electronic device at the clinic to answer questions about how the hot flashes affect their daily life. Other checks will include a medical examination, vital signs (temperature, blood pressure and pulse). Some blood and urine samples will be taken for laboratory tests. At some visits, the women will also have an ECG to check their heart rhythm. 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 tablets of the study medicine (1 tablet of lower or higher dose of fezolinetant and 1 placebo tablet, or 2 placebo tablets).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: f
View:

• Participant confirmed as menopausal per one of the following criteria at the screening visit (visit 1):

‣ Spontaneous amenorrhea for \>/=12 consecutive months;

⁃ Spontaneous amenorrhea for \>/=6 months with biochemical criteria of menopause (follicle-stimulating hormone (FSH) \> 40 IU/L);

⁃ Having had bilateral oophorectomy \>/=6 weeks prior to the screening visit (visit 1) (with or without hysterectomy); or

⁃ Having had hysterectomy without bilateral oophorectomy with the biochemical criteria of menopause (FSH \> 40 IU/L).

• Participant must be seeking treatment or relief for vasomotor symptoms (VMS) associated with menopause and meet some set criteria related to hot flash(es) (HFs) (VMS) prior to randomization.

• Participant agrees not to participate in another interventional study while participating in the present study.

Locations
Other Locations
Japan
National Hospital Organization Beppu Medical Center
Beppu-shi
Sei Women's Clinic
Bunkyo-ku
Chiba Aoba Municipal Hospital
Chiba
Chita Kosei Hospital
Chita-gun
Marunouchi no Mori Ladies Clinic
Chiyoda-ku
Medical Corporation Asbo Tokyo Asbo Clinic
Chuo-ku
Fukuoka Mirai Hospital
Fukuoka
Mori Ladies Clinic
Fukuoka
Nishiguchi Clinic Fujinka
Fukushima
Aiiku Ladies Clinic
Funabashi-shi
Medical Corp. SEIKOUKAI New Medical Research System Clinic
Hachioji-shi
Sadamori Ladies Clinic
Hiroshima
Kosumo Clinic
Kako-gun
Shonan Kamakura General Hospital
Kamakura
National Hospital Organization Kanazawa Medical Center
Kanazawa
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi
National Hospital Organization Osaka Minami Medical Center
Kawachinagano-shi
Kawasakieki Fumi Ladies Clinic
Kawasaki-shi
Koukan Clinic
Kawasaki-shi
Shinkawasaki Kobiki Womens Clinic
Kawasaki-shi
Konan Kosei Hospital
Kōnan
Omi Medical Center, Social Medical Corporation Seikoukai
Kusatsu-shi
Rakuwakai Otowa Hospital
Kyoto
Machida Municipal Hospital
Machida-shi
Juno Vesta Clinic hatta
Matsudo-shi
Social Medical Care Corporation Hosei-kai Marunouchi Hospital
Matsumoto-shi
Toranomon Womens Clinic
Minato-ku
Kichijyoji Ladies Clinic
Musashino-shi
Daido Clinic
Nagoya
MEITETSU Hospital
Nagoya
Shimamura Memorial Hospital
Nerima-ku
Yukawa Women'S Clinic
Nishi-tokyo-shi
Mari Women'S Clinic
Nisinomiya-shi
Miyabi Uro-Gyne Clinic
Okayama
Omihachiman Community Medical Center
Ōmihachiman
Chayamachi Ladies Clinic
Osaka
Chiharu Clinic
Osaka
GyNet Medical Corporation Minamimorimachi Ladies' Clinic
Osaka
Kitahorie Kanade Ladies Clinic
Osaka
Komorebi Ladies Clinic Osaka Honmachi
Osaka
Ninomiya Ladies Clinic
Osaka
Rikako Ladies Clinic
Osaka
Tennoji Chihiro Women's Clinic
Osaka
OHARA Clinic
Saitama
Maruyama Memorial General Hospital
Saitama-shi
Shimizu Ladies Clinic
Sakai-shi
Kotoni Ladies Clinic
Sapporo
M's Ladies Clinic
Sapporo
Miyanomori Ladies' Clinic
Sapporo
NISHIKAWA Women's Health Clinic
Sapporo
Social Medical Corporation Caress Sapporo Caress Memorial Hospital
Sapporo
Chieko Yukika Lady's Clinic
Sendai
Japan Community Health care Organization Tokuyama Central Hospital
Shunan-shi
Shimodaira Ladies Clinic
Suginami-ku
Asahi Clinic
Takamatsu
National Hospital Organization Takasaki General Medical Center
Takasaki-shi
Sato Hospital
Takasaki-shi
jMOG Medical Corporation Tanabe Ladies' Clinic
Takatsuki-shi
Medical Corporation Associa Tamacenter Ladies Clinic
Tama-shi
JA Toride Medical Center
Toride
Toyota Kosei Hospital
Toyota-shi
Tsukuba Urocare Clinic
Tsukuba
Motomachi Ladies Clinic
Yokohama
Women's Clinic LUNA Yokohama Motomachi
Yokohama
Time Frame
Start Date: 2024-02-16
Completion Date: 2025-12-31
Participants
Target number of participants: 410
Treatments
Experimental: Fezolinetant low dose
Participants will receive low dose of fezolinetant and placebo once daily for 12 weeks.
Experimental: Fezolinetant high dose
Participants will receive high dose of fezolinetant and placebo once daily for 12 weeks.
Placebo_comparator: Placebo
Participants will receive matching placebo once daily for 12 weeks.
Sponsors
Leads: Astellas Pharma Inc

This content was sourced from clinicaltrials.gov