302 A Phase 3 Efficacy&Safety Study of Fezolinetant in women with VMS

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering from Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated with Menopause

• IRAS ID

  263223

• Contact name

  Ronnie Beboso

• Contact email

  rbeboso@medinovaresearch.com

• Sponsor organisation

  Astellas Pharm Global Developement, Inc.

• Eudract number

  2018-003529-27

• Duration of Study in the UK

  1 years, 11 months, 28 days

• Research summary

  Summary of Research

  This study is a randomised, placebo controlled, double blind phase 3 clinical study aiming to investigate the safety and efficacy 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 200 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 18 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 for 12 weeks, with two of three groups receiving fezolinetant, and the third group receiving placebo. This aims to demonstrate the efficacy of Fezolinetant in control of VMS. Following this 12 weeks, participants will enter into an non-controlled extension treatment phase, meaning all participants will receive Fezolinetant for a further 40 weeks before the study ends.

  Summary of Results

  Does fezolinetant reduce the number and severity of hot flashes?
  Women treated with either fezolinetant 30 mg or 45 mg had fewer and less severe hot flashes compared with placebo treatment.
  What medical problems did these people have during the study?
  What adverse reactions did people have in this study?
  A lot of research is needed to know whether a medicine causes a medical problem. When new medicines are being studied, researchers keep track of all medical problems that people have while they are in the study. These problems are called adverse events and are recorded whether or not they might be caused by the treatment taken.
  An adverse reaction is any medical problem or adverse event that is judged by the study doctor to be possibly caused by a medicine or treatment used in the study.
  Part 1
  60 out of 500 women (12%) had adverse reactions during the first 12 weeks of the study.
  The next table shows the most common adverse reactions reported by women who took at least 1 dose of study medicine (fezolinetant or placebo).

  79 out of 484 women (16.3%) had adverse reactions in Part 2 of the study. This includes the women who took placebo in Part 1 who were switched to fezolinetant in Part 2. The next table shows the most common adverse reactions reported by the women.

  You can find this summary and more information about this study at
  https://www.trialsummaries.com/
  Further information can be found at the following websites:
  https://clinicaltrials.gov/ ClinicalTrials.gov Identifier: NCT04003142
  https://clinicaltrialsregister.eu EudraCT number: 2018-003529-27

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  19/EM/0249

• Date of REC Opinion

  3 Oct 2019

• REC opinion

  Further Information Favourable Opinion