Hot FlashesPhase 3NCT07829653
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
A Phase 3 study testing Fezolinetant in people with Hot Flashes, run by Astellas Pharma Inc at 1 site in India.
Trial summary
This study is for women in India who are going through menopause. They have symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Fezolinetant is a medicine to treat hot flashes in women going through menopause. Read more about this study
- Who is it for?
- Ages 18 years and older, 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?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 23 Oct 2026to 30 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has a body mass index ≥ 17 kg/m^2 and ≤ 38 kg/m^2 at screening visit.
- Participant must be seeking treatment or relief for VMS associated with menopause and confirmed as menopausal, defined as meeting 1 of the following criteria for natural or surgical menopause at the screening visit:
- Spontaneous amenorrhea for ≥ 12 consecutive months
- Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (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 start of active treatment, participant must have a minimum average of 7 moderate to severe hot flashs (VMS) per day (data must be available for at least 7 of the last 10 days prior to treatment).
- 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 ECG within the reference range for the population studied, or showing no clinically relevant deviations.
- 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], negative hepatitis C virus antibody [HCVAb] and negative human immunodeficiency virus antibody [HIVAb] 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 history of malignancy with the exception of at least 5 years post treatment and without known recurrence.
- Participant has a current malignancy, with the exception of non-metastatic basal cell carcinoma of the skin.
- Participant has a history within the last 6 months prior to screening 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, or who is at significant risk to commit suicide.
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- 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 CYP [cytochrome P450] 1A2 inhibitors, systemic hormone replacement therapy [HRT], or hormonal contraceptive, or any treatment for VMS [prescription, over the counter, off-label 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 35 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 bilirubin (TBL) or direct bilirubin (DBL), elevated international normalized ratio (INR) or elevated alkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to 1.5 x upper limit of normal (ULN) can be enrolled if TBL are normal. Patients with mildly elevated ALP (up to 1.5 x 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 TBL may be enrolled as long as hemolysis is ruled-out (i.e., 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 per 1.73 m^2 at screening.
- Participant has any condition which makes the participant unsuitable for study participation.
- Participant has known or suspected hypersensitivity to fezolinetant or any components of the formulation used.
- Participant is unable or unwilling to complete the study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, Single-arm, 12-week Study to Assess the Efficacy and Safety of Fezolinetant 45 mg in Indian Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause
This study is for women in India who are going through menopause. They have symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Fezolinetant is a medicine to treat hot flashes in women going through menopause. It is currently approved in more than 40 countries, including the US and countries in Europe. Further studies are needed before it is approved for use in India. The aim of this study is to confirm if fezolinetant can help reduce hot flashes in Indian women. Women who want to take part in the study will be given an electronic device or use the app on their own smartphone to track their hot flashes and night sweats. The women will record this information before, during and after taking the study treatment. All the women in the study will take 1 tablet of fezolinetant once a day for up to 12 weeks. During the study, the women will visit the study clinic several times. The researchers will collect information about the women's health and ask about their hot flashes and night sweats. At each visit, they will also be asked if they have any medical problems. The women will have a follow up visit 3 weeks after taking their last tablet of study treatment, to collect information about their health and symptoms. Each woman will be in this study for about 5 months.
- Conditions
- Hot Flashes
- Being tested
- Fezolinetant
- Keywords
- menopause, vasomotor symptoms, ESN364, fezolinetant, VEOZAH™
- 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
| Study group | Role | What they receive |
|---|---|---|
| Fezolinetant | Experimental | Participants will receive fezolinetant once daily for 12 weeks. Receives: Drug: Fezolinetant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in the frequency of moderate to severe vasomotor symptoms (VMS)
Frequency of moderate and severe VMS events will be calculated as sum of moderate and severe VMS events per day.
Measured: Baseline and week 12
Secondary outcomes (16)
Mean change from baseline in the frequency of moderate to severe VMS
Frequency of moderate and severe VMS events will be calculated as sum of moderate and severe VMS events per day.
Measured: Baseline and up to week 12
Mean change from baseline in the severity of moderate to severe VMS
The severity of VMS will be calculated using a weighted average of VMS events.
Measured: Baseline and up to week 12
Mean percent reduction in the frequency of moderate to severe VMS
Frequency of moderate or 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 and up to week 12
Percent reduction ≥ 50% in the frequency of moderate to severe VMS
Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction of ≥ 50% will be reported.
Measured: Baseline and up to week 12
Percent reduction of 100% in the frequency of moderate to severe VMS
Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction of 100% will be reported.
Measured: Baseline and up to week 12
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.
Measured: Up to week 15
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinical significant laboratory values.
Measured: Up to week 15
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinical significant vital sign values.
Measured: Up to week 15
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinical significant ECG values.
Measured: Up to week 12
Pharmacokinetics (PK) of fezolinetant in plasma: Concentration
Concentration will be recorded from the PK plasma samples.
Measured: Up to week 12
PK of metabolite ES259564 in plasma: Concentration
Concentration will be recorded from the PK plasma samples.
Measured: Up to week 12
Change in serum concentrations of sex hormones: luteinizing hormone (LH)
Concentration will be recorded from pharmacodynamics serum samples.
Measured: Baseline and up to Week 15
Change in serum concentrations of sex hormone: follicle-stimulating hormone (FSH)
Concentration will be recorded from pharmacodynamics serum samples.
Measured: Baseline and up to Week 15
Change in serum concentrations of sex hormone: estradiol (E2)
Concentration will be recorded from pharmacodynamics serum samples.
Measured: Baseline and up to Week 15
Change in serum concentrations of sex hormone: testosterone
Concentration will be recorded from pharmacodynamics serum samples.
Measured: Baseline and up to Week 15
Change in serum concentrations of sex hormone-binding globulin (SHBG)
Concentration will be recorded from pharmacodynamics serum samples.
Measured: Baseline and 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.
- First posted21 Sep 2026
- Study start23 Oct 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Associate Mecial Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829653
- Sponsor's protocol ID
- 2693-CL-0315
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Single-arm, 12-week Study to Assess the Efficacy and Safety of Fezolinetant 45 mg in Indian Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause
- ClinicalTrials.gov ID
- NCT07829653
- Acronym / sponsor ID
- 2693-CL-0315
- Conditions
- Hot Flashes
- Keywords
- menopause, vasomotor symptoms, ESN364, fezolinetant, VEOZAH™
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for women in India who are going through menopause. They have symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Fezolinetant is a medicine to treat hot flashes in women going through menopause. It is currently approved in more than 40 countries, including the US and countries in Europe. Further studies are needed before it is approved for use in India. The aim of this study is to confirm if fezolinetant can help reduce hot flashes in Indian women. Women who want to take part in the study will be given an electronic device or use the app on their own smartphone to track their hot flashes and night sweats. The women will record this information before, during and after taking the study treatment. All the women in the study will take 1 tablet of fezolinetant once a day for up to 12 weeks. During the study, the women will visit the study clinic several times. The researchers will collect information about the women's health and ask about their hot flashes and night sweats. At each visit, they will also be asked if they have any medical problems. The women will have a follow up visit 3 weeks after taking their last tablet of study treatment, to collect information about their health and symptoms. Each woman will be in this study for about 5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fezolinetant | Experimental | Drug: FezolinetantParticipants will receive fezolinetant once daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant has a body mass index ≥ 17 kg/m^2 and ≤ 38 kg/m^2 at screening visit.
- Participant must be seeking treatment or relief for VMS associated with menopause and confirmed as menopausal, defined as meeting 1 of the following criteria for natural or surgical menopause at the screening visit:
- Within the 10 days prior to start of active treatment, participant must have a minimum average of 7 moderate to severe hot flashs (VMS) per day (data must be available for at least 7 of the last 10 days prior to treatment).
- 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 ECG within the reference range for the population studied, or showing no clinically relevant deviations.
- Participant has a negative urine pregnancy test at screening; this is not required for participants who have had a total hysterectomy.
Key exclusion criteria (17 listed)
- Participant has known substance abuse or alcohol addiction within 6 months of screening.
- Participant has a history of malignancy with the exception of at least 5 years post treatment and without known recurrence.
- Participant has a current malignancy, with the exception of non-metastatic basal cell carcinoma of the skin.
- Participant has a history within the last 6 months prior to screening 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FezolinetantAlso: ESN364, VEOZAH™Oral | Drug | Fezolinetant |
Primary outcome
Mean change from baseline in the frequency of moderate to severe vasomotor symptoms (VMS)
Time frame: Baseline and week 12
Frequency of moderate and severe VMS events will be calculated as sum of moderate and severe VMS events per day.
16 secondary outcomes
Mean change from baseline in the frequency of moderate to severe VMS
Time frame: Baseline and up to week 12
Mean change from baseline in the severity of moderate to severe VMS
Time frame: Baseline and up to week 12
Mean percent reduction in the frequency of moderate to severe VMS
Time frame: Baseline and up to week 12
Percent reduction ≥ 50% in the frequency of moderate to severe VMS
Time frame: Baseline and up to week 12
Percent reduction of 100% in the frequency of moderate to severe VMS
Time frame: Baseline and up to week 12
Number of participants with adverse events (AEs)
Time frame: Up to week 15
Number of participants with laboratory value abnormalities and/or AEs
Time frame: Up to week 15
Number of participants with vital sign abnormalities and/or AEs
Time frame: Up to week 15
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to week 12
Pharmacokinetics (PK) of fezolinetant in plasma: Concentration
Time frame: Up to week 12
PK of metabolite ES259564 in plasma: Concentration
Time frame: Up to week 12
Change in serum concentrations of sex hormones: luteinizing hormone (LH)
Time frame: Baseline and up to Week 15
Change in serum concentrations of sex hormone: follicle-stimulating hormone (FSH)
Time frame: Baseline and up to Week 15
Change in serum concentrations of sex hormone: estradiol (E2)
Time frame: Baseline and up to Week 15
Change in serum concentrations of sex hormone: testosterone
Time frame: Baseline and up to Week 15
Change in serum concentrations of sex hormone-binding globulin (SHBG)
Time frame: Baseline and up to Week 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: 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/.
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Hot Flashes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Associate Mecial Director study director
Astellas Pharma Global Development, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fezolinetant in people with Hot Flashes, run by Astellas Pharma Inc at 1 site in India.
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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Astellas Pharma Inc. (800-888-7704, Astellas.registration@astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in the frequency of moderate to severe vasomotor symptoms (VMS) (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.