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

StatusNot Yet Recruiting
PhasePhase 3
Started

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Record History

  1. Minor Re-verified, no change to tracked fields
  2. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07829653
Lead Sponsor Astellas Pharma Inc
Conditions
(from sponsor)
Hot Flashes
Related terms Hot Flashes
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov