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New drug could cool menopause hot flashes without hormones

NCT ID NCT06206408

Symptom relief Sponsor: Astellas Pharma Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested fezolinetant, a non-hormonal medicine, in 410 Japanese women with menopause-related hot flashes. Participants took either a low or high dose of fezolinetant or a placebo daily for 12 weeks. The goal was to see if the drug reduces the number and severity of hot flashes compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fezolinetant
What this could lead to
If it works, this could provide a non-hormonal option to reduce hot flashes for Japanese women going through menopause.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all women. Fezolinetant is already approved in the US, but its effectiveness and safety in Japanese women are still being confirmed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

410 people

The number who actually took part.

Started

Feb 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Participant has any condition which makes the participant unsuitable for study participation. * Participant has a known or suspected hypersensitivity to fezolinetant or any components of the formulation used. * Participant is the investigator or a member of the study site staff. * Participant is an employee of Astellas, the study-related contract research organizations (CROs) or site management organization.

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Conditions

The condition(s) this trial relates to.

Hot Flashes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hot flashes

Contacts and locations

Locations

  • Aiiku Ladies Clinic

    Funabashi-shi, Chiba, Japan

  • Asahi Clinic

    Takamatsu, Kagawa-ken, Japan

  • Chayamachi Ladies Clinic

    Osaka, Osaka, Japan

  • Chiba Aoba Municipal Hospital

    Chiba, Chiba, Japan

  • Chieko Yukika Lady's Clinic

    Sendai, Miyagi, Japan

  • Chiharu Clinic

    Osaka, Osaka, Japan

  • Chita Kosei Hospital

    Chita-gun, Aichi-ken, Japan

  • Daido Clinic

    Nagoya, Aichi-ken, Japan

  • Fukuoka Mirai Hospital

    Fukuoka, Fukuoka, Japan

  • GyNet Medical Corporation Minamimorimachi Ladies' Clinic

    Osaka, Osaka, Japan

  • JA Toride Medical Center

    Toride, Ibaraki, Japan

  • Japan Community Health care Organization Tokuyama Central Hospital

    Shunan-shi, Yamaguchi, Japan

  • Juno Vesta Clinic hatta

    Matsudo-shi, Chiba, Japan

  • Kawasakieki Fumi Ladies Clinic

    Kawasaki-shi, Kanagawa, Japan

  • Kichijyoji Ladies Clinic

    Musashino-shi, Tokyo, Japan

  • Kitahorie Kanade Ladies Clinic

    Osaka, Osaka, Japan

  • Komorebi Ladies Clinic Osaka Honmachi

    Osaka, Osaka, Japan

  • Konan Kosei Hospital

    Kōnan, Aichi-ken, Japan

  • Kosumo Clinic

    Kako-gun, Hyōgo, Japan

  • Kotoni Ladies Clinic

    Sapporo, Hokkaido, Japan

  • Koukan Clinic

    Kawasaki-shi, Kanagawa, Japan

  • M's Ladies Clinic

    Sapporo, Hokkaido, Japan

  • MEITETSU Hospital

    Nagoya, Aichi-ken, Japan

  • Machida Municipal Hospital

    Machida-shi, Tokyo, Japan

  • Mari Women'S Clinic

    Nisinomiya-shi, Hyōgo, Japan

  • Marunouchi no Mori Ladies Clinic

    Chiyoda-ku, Tokyo, Japan

  • Maruyama Memorial General Hospital

    Saitama-shi, Saitama, Japan

  • Medical Corp. SEIKOUKAI New Medical Research System Clinic

    Hachioji-shi, Tokyo, Japan

  • Medical Corporation Asbo Tokyo Asbo Clinic

    Chuo-ku, Tokyo, Japan

  • Medical Corporation Associa Tamacenter Ladies Clinic

    Tama-Shi, Tokyo, Japan

  • Miyabi Uro-Gyne Clinic

    Okayama, Okayama-ken, Japan

  • Miyanomori Ladies' Clinic

    Sapporo, Hokkaido, Japan

  • Mori Ladies Clinic

    Fukuoka, Fukuoka, Japan

  • Motomachi Ladies Clinic

    Yokohama, Kanagawa, Japan

  • NISHIKAWA Women's Health Clinic

    Sapporo, Japan

  • National Hospital Organization Beppu Medical Center

    Beppu-shi, Oita Prefecture, Japan

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, Japan

  • National Hospital Organization Osaka Minami Medical Center

    Kawachinagano-shi, Osaka, Japan

  • National Hospital Organization Takasaki General Medical Center

    Takasaki-shi, Gunma, Japan

  • Ninomiya Ladies Clinic

    Osaka, Osaka, Japan

  • Nishiguchi Clinic Fujinka

    Fukushima, Fukushima, Japan

  • OHARA Clinic

    Saitama, Saitama, Japan

  • Omi Medical Center, Social Medical Corporation Seikoukai

    Kusatsu-shi, Shiga, Japan

  • Omihachiman Community Medical Center

    Ōmihachiman, Shiga, Japan

  • Rakuwakai Otowa Hospital

    Kyoto, Kyoto, Japan

  • Rikako Ladies Clinic

    Osaka, Osaka, Japan

  • Sadamori Ladies Clinic

    Hiroshima, Hiroshima, Japan

  • Sato Hospital

    Takasaki-shi, Gunma, Japan

  • Sei Women's Clinic

    Bunkyo-ku, Tokyo, Japan

  • Shimamura Memorial Hospital

    Nerima-ku, Tokyo, Japan

  • Shimizu Ladies Clinic

    Sakai-shi, Osaka, Japan

  • Shimodaira Ladies Clinic

    Suginami-ku, Tokyo, Japan

  • Shinkawasaki Kobiki Womens Clinic

    Kawasaki-shi, Kanagawa, Japan

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa, Japan

  • Social Medical Care Corporation Hosei-kai Marunouchi Hospital

    Matsumoto-shi, Nagano, Japan

  • Social Medical Corporation Caress Sapporo Caress Memorial Hospital

    Sapporo, Hokkaido, Japan

  • Tennoji Chihiro Women's Clinic

    Osaka, Osaka, Japan

  • Toranomon Womens Clinic

    Minato-ku, Tokyo, Japan

  • Toyota Kosei Hospital

    Toyota-shi, Aichi-ken, Japan

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, Chiba, Japan

  • Tsukuba Urocare Clinic

    Tsukuba, Ibaraki, Japan

  • Women's Clinic LUNA Yokohama Motomachi

    Yokohama, Kanagawa, Japan

  • Yukawa Women'S Clinic

    Nishi-Tokyo-shi, Tokyo, Japan

  • jMOG Medical Corporation Tanabe Ladies' Clinic

    Takatsuki-shi, Osaka, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.