304_A phase 3 study to investigate if Fezolinetant helps reduce VMS

• Research type

  Research Study

• Full title

  A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flushes) Associated with Menopause

• IRAS ID

  263227

• Contact name

  Ronnie Beboso

• Contact email

  rbeboso@medinovaresearch.com

• Sponsor organisation

  Astellas Pharm Global Developement, Inc.

• Eudract number

  2019-000275-16

• Duration of Study in the UK

  2 years, 3 months, 7 days

• Research summary

  This study is a randomised, placebo controlled, double blind phase 3 clinical study aiming to investigate the long term safety and tolerability of Fezolinetant when used for hot flushes, also known as vasomotor symptoms (VMS, associated with menopause. Fezolinetant would offer an alternative to hormonal replacement therapies (HRT), a treatment not acceptable in all patient groups. This study aims to recruit women with confirmed vasomotor symptoms associated with menopause, between the ages of 40 and 65 (inclusive), seeking treatment for their symptoms. Participants will be recruited from 250 centres globally.
  Participants of the study will undergo a 5 week screening period to determine the severity of their hot flushes which will allow the study team to compare the change to their symptoms following the beginning of the study. This will be followed by a number of clinical tests to ensure they meet the physical health requirements for participation. The treatment phase will be 52 weeks long and involve 17 visits to the study site. Participants of the study will self report on the changes in their symptoms as well as other general health and lifestyle factors. A number of clinical examinations will also be performed before, during and in the follow up phase of the study to ensure the long term safety of fezolinetant on the physical health of the participants. The study will be placebo controlled, where 33% of participants will not receive Fezolinetant and will act as the control group. 33% of the population will receive a 45mg dose of Fezolinetant and 33% will receive a 30mg dose. Safety of Fezolinetant will be determined on the basis of adverse events occuring over the course of the study period.

• REC name

  HSC REC A

• REC reference

  19/NI/0140

• Date of REC Opinion

  3 Sep 2019

• REC opinion

  Further Information Favourable Opinion