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

Last updated: March 19, 2025
Sponsor: Astellas Pharma Global Development, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

Fezolinetant

Clinical Study ID

NCT06812754
2693-CL-0313
  • Ages 40-65
  • Female

Study 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.

Fezolinetant is approved in several countries to treat hot flashes in women going through menopause. Further studies are needed before it is available in other regions such as Asia.

The goal of this study is to confirm if fezolinetant helps reduce hot flashes in Chinese women going through menopause. This study will also confirm the safety of fezolinetant and how well the women cope with (tolerate) the treatment. The women will take 1 tablet of the study medicine either fezolinetant or placebo once a day for up to 12 weeks. This is decided by chance alone. The placebo looks like fezolinetant but will not have any medicine in it.

Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes and night sweats. The women will record this information before, during and after taking the study treatment. During the study, the women will visit the study clinic several times. At each visit they will be asked if they had any medical problems. The women will have general safety checks. At some visits, a breast ultrasound (mammogram), cervical smear, and ultrasound of the womb (uterus) may be done.

The last clinic visit will be 3 weeks after the women take their final tablet of the study medicine (fezolinetant or placebo).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has a body mass index >/= 16 kg/m2 and </= 38 kg/m2 at screening visit.

  • Participant must be seeking treatment or relief for vasomotor symptom(s) (VMS)associated with menopause and confirmed as menopausal per 1 of the followingcriteria at the screening visit:

  • Spontaneous amenorrhea for >/= 12 consecutive months

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

  • Having had bilateral oophorectomy >/= 6 weeks prior to the screening visit (with or without hysterectomy).

  • FSH > 40 IU/L if participants received hysterectomy but still have anovary/ovaries.

  • Within the 10 days prior to randomization, participant must have a minimum averageof 7 moderate to severe hot flash(es) (HFs) (VMS) per day (data must be availablefor at least 7 of the last 10 days prior to randomization).

  • Participant is in good general health as determined on the basis of medical historyand general physical examination, performed at the screening visit; hematology andbiochemistry parameters, pulse rate and/or blood pressure, and electrocardiogram (ECG) within the reference range for the population studied, or showing noclinically relevant deviations.

  • Participant has documentation of a normal/negative or no clinically significantfindings mammogram (or breast ultrasound) (e.g., < Breast Imaging-Reporting and DataSystem (BI-RADS) class 4; obtained at screening or within the prior 12 months ofstudy enrollment). Appropriate documentation includes a written report or anelectronic report indicating normal/negative or no clinically significantmammographic findings.

  • Participant is willing to undergo a transvaginal ultrasound (TVU) to evaluate theuterus and ovaries at screening and week 12 (end of treatment (EOT)), and forparticipants who are withdrawn from the study prior to completion, a TVU at theearly discontinuation (ED) visit. This is not required for participants who have hada partial (supracervical) or total hysterectomy.

  • Participant has documentation of a normal or not clinically significant Pap test (orequivalent cervical cytology) within the previous 12 months of study enrollment orat screening. This is not required for participants who have had a totalhysterectomy.

  • Participant has a negative urine pregnancy test at screening; this is not requiredfor participants who have had a total hysterectomy.

  • Participant has a negative serology panel [i.e., negative hepatitis B surfaceantigen (HBsAg) and negative hepatitis C virus antibody (HCVAb) screens] atscreening.

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

Exclusion

Exclusion Criteria:

  • Participant has known substance abuse or alcohol addiction within 6 months ofscreening.

  • Participant has a current malignancy, with exception of non-metastatic basal cellcarcinoma of the skin.

  • Participant has a history of malignancy with exceptions of at least 5 yearspost-treatment and without known recurrence.

  • For participants with a uterus: Participant has an unacceptable result from the TVUassessment at screening, i.e., full length of endometrial cavity cannot bevisualized or presence of a clinically significant finding.

  • Participant has a history within the last 6 months of undiagnosed uterine bleeding.

  • Participant has a medical condition or chronic disease (including history ofneurological [including cognitive], hepatic, renal, cardiovascular,gastrointestinal, pulmonary [e.g., moderate asthma], endocrine, or gynecologicaldisease) or malignancy that could confound interpretation of the study outcome.

  • Participant has a history of suicide attempt or suicidal behavior within the last 12months or has suicidal ideation within the last 12 months (a response of "yes" toquestion 4 or 5 on the suicidal ideation portion of the Columbia-Suicide SeverityRating Scale [C-SSRS]), or who is at significant risk to commit suicide at screening [visit 1].

  • Participant has previously been enrolled in a clinical trial with fezolinetant orother neurokinin (NK) receptor antagonists.

  • Participant uses a prohibited therapy (strong and moderate cytochrome P450 1A2 [CYP1A2] inhibitors, hormone replacement therapy (HRT), hormonal contraceptive orany treatment for VMS [prescription, over-the-counter, or herbal]) or is not willingto wash-out and discontinue use of such drugs for the full duration of studyconduct.

  • Participant has received any investigational therapy within 28 days or 5 half-lives,whichever is longer, prior to screening.

  • Participant has uncontrolled hypertension, defined as systolic blood pressure >/=140mmHg or diastolic blood pressure as >/= 90 mmHg based on an average of 2 to 3readings within the screening period.

  • Participants with a medical history of hypertension who are well controlled maybe enrolled

  • Participants who do not meet these criteria may be re-assessed after initiationor review of antihypertensive measures

  • Participant has active liver disease, jaundice, elevated liver aminotransferases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)), elevated totalor direct bilirubin, elevated international normalized ratio (INR) or elevatedalkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to 1.5 ×upper limit of normal (ULN) can be enrolled if total and direct bilirubin arenormal. Patients with mildly elevated ALP (up to 1.5 × ULN) can be enrolled ifcholestatic liver disease is excluded and no cause other than fatty liver isdiagnosed. Patients with Gilbert's syndrome with elevated total bilirubin (TBL) maybe enrolled as long as hemolysis is ruled-out (i.e., direct bilirubin, hemoglobinand reticulocytes are normal).

  • Participant has creatinine > 1.5 × ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula </=30 mL/min/1.73 m2at screening.

  • Participant has a positive result for human immunodeficiency virus (HIV) atscreening.

  • Participant has any condition which makes the participant unsuitable for studyparticipation.

  • Participant is unable or unwilling to complete the study procedures.

  • Participant has a known or suspected hypersensitivity to fezolinetant or anycomponents of the formulation used.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 10, 2025
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Guangzhou Medical University - The Third Affiliated Hospital

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The second Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Active - Recruiting

  • Jiang Maternal and Child Health Hospital

    Nan Chang, Jiang XI
    China

    Active - Recruiting

  • Jiangxi Maternal and Child Health Hospital

    Nan Chang, Jiang XI
    China

    Active - Recruiting

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