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Hot FlashesPhase 2NCT06812754

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

A Phase 2 study testing Fezolinetant in people with Hot Flashes, run by Astellas Pharma Global Development, Inc. at 26 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years, women only
Conditions the study is for
Hot Flashes
What is being tested?
Fezolinetant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
26 sitesChina
Study dates
10 Mar 2025to 5 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Participant has a positive result for human immunodeficiency virus (HIV) at screening.
  • Participant has any condition which makes the participant unsuitable for study participation.
  • Participant is unable or unwilling to complete the study procedures.
  • Participant has a known or suspected hypersensitivity to fezolinetant or any components of the formulation used.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

China26 sites

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Capital Medical University (CMU) - Beijing Shijitan Hospital

    Beijing, Beijing Municipality

  • Capital Medical University - Beijing Obstetrics and Gynecology Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Jilin Province FAW General Hospital

    Changchun, Jilin

  • Hunan Provincial Maternal and Child Health Care Hospital

    Changsha, Hunan

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan

  • Guangzhou Medical University - The Third Affiliated Hospital

    Guangzhou, Guangdong

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

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Hainan Women and Children's Medical Center

    Haikou, Hainan

  • Jinan Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong

  • Shandong Provincial Hospital

    Jinan, Shandong

  • Guangxi Medical University (GXMU) - Liuzhou Renmin Hospital

    Liuzhou, Guangxi

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi

  • Nanjing First Hospital

    Nanjing, Jiangsu

  • Southeast University, ZhongDa Hospital

    Nanjing, Jiangsu

  • Shanghai First Maternity and Infant Hospital

    Shanghai, Shanghai Municipality

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

  • Shenzhen Maternal & Child Health Hospital

    Shenzhen, Guangdong

  • The second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Shanxi Woman and Children Hospital

    Taiyuan, Shanxi

  • The First hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality

  • Xiangya Hospital, Central South University

    Zhuzhou, Hunan

Other trials in China

About this study

Official title: A Phase 2, Randomized, Placebo-controlled, 12-week, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant 45 mg in Chinese Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause

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.

Read more

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
Being tested
Fezolinetant, Placebo
Keywords
ESN364, vasomotor symptoms, fezolinetant, VEOZAH™, menopause
Medical subject headings
Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FezolinetantDrug

    Also called ESN364, VEOZAH™

    oral

  • PlaceboDrug

    oral

Study groups in NCT06812754
Study groupRoleWhat they receive
FezolinetantExperimentalParticipants will receive fezolinetant once daily for 12 weeks.
Receives: Drug: Fezolinetant
PlaceboPlacebo comparatorParticipants will receive matching placebo once daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 12

Secondary outcomes (14)

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

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

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

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

    The severity of VMS will be calculated using a weighted average of VMS events.

    Measured: Baseline to Week 12

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

    The severity of VMS will be calculated using a weighted average of VMS events.

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

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

    Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Mean percent reduction will be reported.

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

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

    Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of >/= 50% will be reported.

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

  6. Percent reduction at 100% in the frequency of moderate to severe VMS from baseline to each week up to week 12

    Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of 100% will be reported.

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

  7. Number of participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.

    Measured: Up to Week 15

  8. Change from baseline in endometrial thickness in post-menopausal participants

    Endometrial thickness is a measure of how thick the lining of the uterus is. Endometrial thickness will be measured by transvaginal ultrasound (TVU).

    Measured: Baseline up to Week 12

  9. Number of participants with laboratory value abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to Week 15

  10. Number of participants with vital sign abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to Week 15

  11. Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)

    Number of participants with potentially clinically significant ECG values.

    Measured: Up to Week 12

  12. Pharmacokinetics (PK) of Fezolinetant in plasma: Concentration

    Concentration will be recorded from the PK plasma samples collected.

    Measured: Up to Week 12

  13. Pharmacokinetics (PK) of metabolite ES259564 in plasma: Concentration

    Concentration will be recorded from the PK plasma samples collected.

    Measured: Up to Week 12

  14. Change in serum concentrations of sex hormones

    Sex hormone biomarker levels will be recorded from serum samples.

    Measured: Baseline up to Week 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start10 Mar 2025
  3. Primary completion11 Feb 2026
  4. Study completion5 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06812754
Sponsor's protocol ID
2693-CL-0313
Other IDs
CTR20250084
Status last verified
Mar 2026
First submitted
3 Feb 2025
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fezolinetant in people with Hot Flashes, run by Astellas Pharma Global Development, Inc. at 26 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in the frequency of moderate to severe Vasomotor Symptoms (VMS) from baseline to week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06812754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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