Menu
Search Clinical Trials
Back to Search Results
Will Be Recruiting
Astellas Study ID
2693-CL-0315

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

Astellas Study ID
2693-CL-0315
Clinicaltrials.gov ID
NCT07829653
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
Get more information

Study 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. 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.

Additional Study Details

Phase
Phase 3
Product
fezolinetant
Product
Fezolinetant
Type
Interventional
Masking
None (Open Label)
Enrollment number
100
Show Additional Study Details

Get more information

Would you like more information about clinical trial sites that are recruiting participants for A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
  • A healthcare provider
  • A parent
  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

    Locations

    No locations found.
    Trial info
    Follow Trial
    Age
    18+ years
    Diamond icon
    Condition
  • Hot Flashes
    • Gender icon
    Sex
    Female
    Calendar icon
    Trial Dates
    Oct 2026 - Mar 2028
    Additional Study Details
    Inclusion Criteria
    • 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.
    • 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.
    MaximizeExclusion Criteria
    • 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.
    • 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.

    Frequently Asked Questions

    Are clinical trials only for people with advanced cancer?

    While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

    Will I have to stop my current treatment to participate in a clinical trial?

    Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

    Should I be worried about getting a placebo?

    In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

    Do I need a referral from my doctor to take part in a study?

    Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

    Explore More

    1

    What are clinical trials?

    Find a Trial
    2

    Why are Clinical Trials Important?

    Learn More
    3

    Why Participate in a Clinical Trial?

    Discover More