A phase 3 efficacy and 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 Skylight 1

• IRAS ID

  264365

• Contact name

  Ronnie Beboso

• Contact email

  rbeboso@medinovaresearch.com

• Sponsor organisation

  Astellas Pharma Global Development, Inc.

• Eudract number

  2018-003528-35

• Duration of Study in the UK

  2 years, 0 months, 3 days

• Research summary

  Research Summary
  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.
  Potential participants of the study will undergo during a 5 week screening period a number of clinical test to determine if they are eligible to participate. If participants are deemed eligible to participate the treatment phase will start. Treatment phase is 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 2 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.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  19/SC/0374

• Date of REC Opinion

  21 Nov 2019

• REC opinion

  Further Information Favourable Opinion