A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause

NCT06206408 | Completed Phase 3 DMC

• 2 other identifiers: 2693-CL-0310jRCT2031230571
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 64

Brief 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).

Conditions

Hot Flashes

Keywords

menopause;; ESN364;; vasomotor symptoms;; fezolinetant;; VEOZAH™

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in the frequency of mild to severe vasomotor symptoms (VMS)

  Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day.

  Baseline and Week 8

Secondary Outcomes (17)

• Mean change from baseline in the frequency of mild to severe VMS

  Baseline and up to Week 12

• Mean change from baseline in the frequency of moderate to severe VMS

  Baseline and up to Week 12

• Mean percent reduction in the frequency of mild to severe VMS from baseline

  Baseline and up to Week 12

• Mean percent reduction in the frequency of moderate to severe VMS from baseline

  Baseline and up to Week 12

• Percent reduction of >/= 50% in the frequency of mild to severe VMS from baseline

  Baseline and up to Week 12

Study Arms (3)

Fezolinetant low dose

EXPERIMENTAL

Participants will receive low dose of fezolinetant and placebo once daily for 12 weeks.

Drug: Fezolinetant; Drug: Placebo

Fezolinetant high dose

EXPERIMENTAL

Participants will receive high dose of fezolinetant and placebo once daily for 12 weeks.

Drug: Fezolinetant; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo once daily for 12 weeks.

Drug: Placebo

Interventions

Fezolinetant DRUG

oral

Also known as: ESN364;, VEOZAH™

Fezolinetant high dose; Fezolinetant low dose

Placebo DRUG

oral

Fezolinetant high dose; Fezolinetant low dose; Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participant has a history of an undiagnosed uterine bleeding within the 6 months prior to the screening visit (visit 1).
• Participant has a current malignant tumor or history (except for a participant who has not received treatment for malignant tumors for at least 5 years before informed consent acquisition and was not considered to have recurrence) of a malignant tumor except for non-metastatic basal cell carcinoma of the skin.
• Participant has a medical condition or chronic disease (including history of neurological \[including cognitive\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\], endocrine, or gynecological disease) that could confound interpretation of the study outcome.
• Participant uses a prohibited therapy (hormone therapy, hormone replacement therapy (HRT), hormonal contraceptive, any treatment for menopausal symptoms \[prescription medications, over-the-counter, or herbal/Kampo medicines\] or strong or moderate cytochrome P450 1A2 (CYP1A2) inhibitors) and is not willing to wash out or discontinue use of such drugs from screening visit (visit 1) through the follow-up visit (visit 6) or it is not medically appropriate to discontinue such drugs for the duration of the study.
• Participant has been randomized/registered in a clinical study with fezolinetant previously or had previous exposure to marketed fezolinetant elsewhere.
• Participant has a present or previous history of participation in this study.
• Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening (visit 1).
• Participant has an unacceptable result from the transvaginal ultrasound (TVU) assessment at screening (i.e., full length of endometrial cavity cannot be visualized or presence of clinically significant abnormal findings).
• Participant has documentation of a clinically significant abnormal Papanicolaou (Pap) test (or equivalent cervical cytology) within the 12 months prior to the screening visit (visit 1) or at screening.
• Participant has active liver disease, jaundice, or elevated liver aminotransferases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)), elevated total bilirubin (TBL) or direct bilirubin (DBL), elevated international normalized ratio (INR), or elevated alkaline phosphatase (ALP) at screening. A participant with mildly elevated ALT or AST up to \< 1.5 × upper limit of normal (ULN) can be enrolled if TBL and DBL are normal. Participant with mildly elevated ALP (up to \< 1.5 × ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Participant with Gilbert's syndrome with elevated TBL may be enrolled as long as DBL, hemoglobin and reticulocytes are normal.
• Participant has creatinine \> 1.5 × ULN or estimated glomerular filtration rate using the Modification of Diet in Renal Disease formula \</=30 mL/min/1.73 m\^2 at screening.
• Participant has positive hepatitis serology panel (i.e., positive hepatitis B surface (HBs) antigen and/or positive hepatitis C virus (HCV) antibody) at screening. If HCV antibody test result is equivocal, hepatitis C virus ribonucleic acid (HCV RNA) test at study site is allowed. Participant can be enrolled if that result is normal or not abnormal.
• Participant is not in good general health as determined on the basis of medical history and general physical examination performed at the screening; hematology parameters, biochemistry parameters, pulse rate, blood pressure, electrocardiogram (ECG) outside the reference range for the population studied, or is showing clinically relevant deviations.
• Participant has a history of suicide attempt or suicidal behavior within the 12 months prior to study enrollment or suicidal ideation within the 12 months prior to study enrollment (a response of "yes" to question 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS)), or is at significant risk to commit suicide at day 1 (visit 2).
• Participant is unable or unwilling to complete the study procedures.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (64)

Chita Kosei Hospital

Chita-gun, Aichi-ken, Japan

Location

Konan Kosei Hospital

Kōnan, Aichi-ken, Japan

Location

Daido Clinic

Nagoya, Aichi-ken, Japan

Location

MEITETSU Hospital

Nagoya, Aichi-ken, Japan

Location

Toyota Kosei Hospital

Toyota-shi, Aichi-ken, Japan

Location

Chiba Aoba Municipal Hospital

Chiba, Chiba, Japan

Location

Aiiku Ladies Clinic

Funabashi-shi, Chiba, Japan

Location

Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Chiba, Japan

Location

Juno Vesta Clinic hatta

Matsudo-shi, Chiba, Japan

Location

Fukuoka Mirai Hospital

Fukuoka, Fukuoka, Japan

Location

Mori Ladies Clinic

Fukuoka, Fukuoka, Japan

Location

Nishiguchi Clinic Fujinka

Fukushima, Fukushima, Japan

Location

National Hospital Organization Takasaki General Medical Center

Takasaki-shi, Gunma, Japan

Location

Sato Hospital

Takasaki-shi, Gunma, Japan

Location

Sadamori Ladies Clinic

Hiroshima, Hiroshima, Japan

Location

Kotoni Ladies Clinic

Sapporo, Hokkaido, Japan

Location

M's Ladies Clinic

Sapporo, Hokkaido, Japan

Location

Miyanomori Ladies' Clinic

Sapporo, Hokkaido, Japan

Location

Social Medical Corporation Caress Sapporo Caress Memorial Hospital

Sapporo, Hokkaido, Japan

Location

Kosumo Clinic

Kako-gun, Hyōgo, Japan

Location

Mari Women'S Clinic

Nisinomiya-shi, Hyōgo, Japan

Location

JA Toride Medical Center

Toride, Ibaraki, Japan

Location

Tsukuba Urocare Clinic

Tsukuba, Ibaraki, Japan

Location

National Hospital Organization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, Japan

Location

Asahi Clinic

Takamatsu, Kagawa-ken, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Location

Kawasakieki Fumi Ladies Clinic

Kawasaki-shi, Kanagawa, Japan

Location

Koukan Clinic

Kawasaki-shi, Kanagawa, Japan

Location

Shinkawasaki Kobiki Womens Clinic

Kawasaki-shi, Kanagawa, Japan

Location

Motomachi Ladies Clinic

Yokohama, Kanagawa, Japan

Location

Women's Clinic LUNA Yokohama Motomachi

Yokohama, Kanagawa, Japan

Location

Rakuwakai Otowa Hospital

Kyoto, Kyoto, Japan

Location

Chieko Yukika Lady's Clinic

Sendai, Miyagi, Japan

Location

Social Medical Care Corporation Hosei-kai Marunouchi Hospital

Matsumoto-shi, Nagano, Japan

Location

National Hospital Organization Beppu Medical Center

Beppu-shi, Oita Prefecture, Japan

Location

Miyabi Uro-Gyne Clinic

Okayama, Okayama-ken, Japan

Location

National Hospital Organization Osaka Minami Medical Center

Kawachinagano-shi, Osaka, Japan

Location

Chayamachi Ladies Clinic

Osaka, Osaka, Japan

Location

Chiharu Clinic

Osaka, Osaka, Japan

Location

GyNet Medical Corporation Minamimorimachi Ladies' Clinic

Osaka, Osaka, Japan

Location

Kitahorie Kanade Ladies Clinic

Osaka, Osaka, Japan

Location

Komorebi Ladies Clinic Osaka Honmachi

Osaka, Osaka, Japan

Location

Ninomiya Ladies Clinic

Osaka, Osaka, Japan

Location

Rikako Ladies Clinic

Osaka, Osaka, Japan

Location

Tennoji Chihiro Women's Clinic

Osaka, Osaka, Japan

Location

Shimizu Ladies Clinic

Sakai-shi, Osaka, Japan

Location

jMOG Medical Corporation Tanabe Ladies' Clinic

Takatsuki-shi, Osaka, Japan

Location

OHARA Clinic

Saitama, Saitama, Japan

Location

Maruyama Memorial General Hospital

Saitama-shi, Saitama, Japan

Location

Omi Medical Center, Social Medical Corporation Seikoukai

Kusatsu-shi, Shiga, Japan

Location

Omihachiman Community Medical Center

Ōmihachiman, Shiga, Japan

Location

Sei Women's Clinic

Bunkyo-ku, Tokyo, Japan

Location

Marunouchi no Mori Ladies Clinic

Chiyoda-ku, Tokyo, Japan

Location

Medical Corporation Asbo Tokyo Asbo Clinic

Chuo-ku, Tokyo, Japan

Location

Medical Corp. SEIKOUKAI New Medical Research System Clinic

Hachioji-shi, Tokyo, Japan

Location

Machida Municipal Hospital

Machida-shi, Tokyo, Japan

Location

Toranomon Womens Clinic

Minato-ku, Tokyo, Japan

Location

Kichijyoji Ladies Clinic

Musashino-shi, Tokyo, Japan

Location

Shimamura Memorial Hospital

Nerima-ku, Tokyo, Japan

Location

Yukawa Women'S Clinic

Nishi-Tokyo-shi, Tokyo, Japan

Location

Shimodaira Ladies Clinic

Suginami-ku, Tokyo, Japan

Location

Medical Corporation Associa Tamacenter Ladies Clinic

Tama-Shi, Tokyo, Japan

Location

Japan Community Health care Organization Tokuyama Central Hospital

Shunan-shi, Yamaguchi, Japan

Location

NISHIKAWA Women's Health Clinic

Sapporo, Japan

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

fezolinetant

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Associate Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: February 16, 2024
• Primary Completion: October 22, 2025
• Study Completion: December 18, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

JP (64)