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

NCT06812754 | Completed Phase 2 DMC

• 2 other identifiers: 2693-CL-0313CTR20250084
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 26

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. 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).

Conditions

Hot Flashes

Keywords

ESN364; vasomotor symptoms; fezolinetant; VEOZAH™; menopause

Outcome Measures

Primary Outcomes (1)

• Mean change in the frequency of moderate to severe Vasomotor Symptoms (VMS) from baseline to week 12

  Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day.

  Baseline to Week 12

Secondary Outcomes (14)

• Mean change in the frequency of moderate to severe VMS from baseline to each week up to week 12

  Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Mean change in the severity of moderate to severe VMS from baseline to week 12

  Baseline to Week 12

• Mean change in the severity of moderate to severe VMS from baseline to each week up to week 12

  Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Mean percent reduction in the frequency of moderate to severe VMS from baseline to each week up to week 12

  Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Percent reduction >/= 50% in the frequency of moderate to severe VMS from baseline to each week up to week 12

  Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Study Arms (2)

Fezolinetant

EXPERIMENTAL

Participants will receive fezolinetant once daily for 12 weeks.

Drug: Fezolinetant

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

Placebo DRUG

oral

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 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 following criteria 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 an ovary/ovaries.
• Within the 10 days prior to randomization, participant must have a minimum average of 7 moderate to severe hot flash(es) (HFs) (VMS) per day (data must be available for at least 7 of the last 10 days prior to randomization).
• Participant is in good general health as determined on the basis of medical history and general physical examination, performed at the screening visit; hematology and biochemistry parameters, pulse rate and/or blood pressure, and electrocardiogram (ECG) within the reference range for the population studied, or showing no clinically relevant deviations.
• Participant has documentation of a normal/negative or no clinically significant findings mammogram (or breast ultrasound) (e.g., \< Breast Imaging-Reporting and Data System (BI-RADS) class 4; obtained at screening or within the prior 12 months of study enrollment). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings.
• Participant is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and week 12 (end of treatment (EOT)), and for participants who are withdrawn from the study prior to completion, a TVU at the early discontinuation (ED) visit. This is not required for participants who have had a partial (supracervical) or total hysterectomy.
• Participant has documentation of a normal or not clinically significant Pap test (or equivalent cervical cytology) within the previous 12 months of study enrollment or at screening. This is not required for participants who have had a total hysterectomy.
• Participant has a negative urine pregnancy test at screening; this is not required for participants who have had a total hysterectomy.
• Participant has a negative serology panel \[i.e., negative hepatitis B surface antigen (HBsAg) and negative hepatitis C virus antibody (HCVAb) screens\] at screening.
• Participant agrees not to participate in another interventional study while participating in the present study.

You may not qualify if:

• Participant has known substance abuse or alcohol addiction within 6 months of screening.
• Participant has a current malignancy, with exception of non-metastatic basal cell carcinoma of the skin.
• Participant has a history of malignancy with exceptions of at least 5 years post-treatment and without known recurrence.
• For participants with a uterus: Participant has an unacceptable result from the TVU assessment at screening, i.e., full length of endometrial cavity cannot be visualized 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 of neurological \[including cognitive\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\], endocrine, or gynecological disease) or malignancy that could confound interpretation of the study outcome.
• Participant has a history of suicide attempt or suicidal behavior within the last 12 months or has suicidal ideation within the last 12 months (a response of "yes" to question 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating 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 or other neurokinin (NK) receptor antagonists.
• Participant uses a prohibited therapy (strong and moderate cytochrome P450 1A2 \[CYP1A2\] inhibitors, hormone replacement therapy (HRT), hormonal contraceptive or any treatment for VMS \[prescription, over-the-counter, or herbal\]) or is not willing to wash-out and discontinue use of such drugs for the full duration of study conduct.
• 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 \>/=140 mmHg or diastolic blood pressure as \>/= 90 mmHg based on an average of 2 to 3 readings within the screening period.
• Participants with a medical history of hypertension who are well controlled may be enrolled
• Participants who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures
• Participant has active liver disease, jaundice, elevated liver aminotransferases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)), elevated total or direct bilirubin, elevated international normalized ratio (INR) or elevated alkaline 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 are normal. Patients 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. Patients with Gilbert's syndrome with elevated total bilirubin (TBL) may be enrolled as long as hemolysis is ruled-out (i.e., direct bilirubin, hemoglobin and 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 m2 at screening.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (26)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

Capital Medical University (CMU) - Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Location

Capital Medical University - Beijing Obstetrics and Gynecology Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Guangzhou Medical University - The Third Affiliated Hospital

Guangzhou, Guangdong, China

Location

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Shenzhen Maternal & Child Health Hospital

Shenzhen, Guangdong, China

Location

Guangxi Medical University (GXMU) - Liuzhou Renmin Hospital

Liuchow, Guangxi, China

Location

Liuzhou Worker's Hospital

Liuchow, Guangxi, China

Location

Hainan Women and Children's Medical Center

Haikou, Hainan, China

Location

The second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, China

Location

Xiangya Hospital, Central South University

Zhuzhou, Hunan, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

Southeast University, ZhongDa Hospital

Nanjing, Jiangsu, China

Location

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

Location

Jilin Province FAW General Hospital

Changchun, Jilin, China

Location

Jinan Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

Location

Shanxi Woman and Children Hospital

Taiyuan, Shanxi, China

Location

The First hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

fezolinetant

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Physician

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: February 3, 2025
• First Posted: February 6, 2025
• Study Start: March 10, 2025
• Primary Completion: February 11, 2026
• Study Completion: March 5, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

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

CN (26)