Study summary

The primary purpose of this study was to evaluate the effect of ESN364 on the severity and frequency of

hot flashes in early postmenopausal women suffering from hot flashes, in terms of changes in weekly Hot

Flash Score from baseline to Week 12.

This study also evaluated the effect of ESN364 on the severity and frequency of hot flashes at additional timepoints; hot flash interference on daily life, in terms of changes from baseline over time in Hot Flash Related Daily Interference Scale (HFRDIS); the effect of ESN364 on climacteric symptoms, in terms of changes from baseline over time in Leeds Sleep Evaluation Questionnaire (LSEQ), Greene Climacteric Scale (GCS), and Sheehan Disability Scale (SDS); pharmacodynamic (PD) effect; and safety and tolerability.

Additional Study Details

Phase
Phase 2
Product
  • Fezolinetant
  • Placebo
  • Type
    Interventional
    Masking
    Double (Participant, Investigator)
    Enrollment number
    87
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English
    Protocol
    Available Language(s): English
    Statistical Analysis Plan (SAP)
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes? Contact us by filling out your information to the right and we’ll respond to you.

    • A patient
    • A caregiver
    • A parent
    • A healthcare provider
    • 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
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    • Iceland
    • India
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    • Italy
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    • Netherlands
    • New Zealand
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    • Panama
    • Peru
    • Philippines
    • Poland
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    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
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    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
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    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

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      Locations

      Contact Us
      Contact Us
      Completed
      Site BE32001
      Gent, Belgium, 9000
      Completed
      Site BE32003
      Genk, Belgium, 3600
      Completed
      Site BE32004
      Brussels, Belgium, 1000
      Completed
      Site BE32005
      Kraainem, Belgium, 1950
      Completed
      Site BE32006
      Jette, Belgium, 1090
      Completed
      Site BE32007
      Leuven, Belgium
      Completed
      Site BE32008
      Mons, Belgium, 7000
      Completed
      Site BE32009
      Tienen, Belgium, 3300

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