OASIS 3

• Research type

  Research Study

• Full title

  A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women.

• IRAS ID

  1003957

• Contact name

  Lineke Zuurman

• Contact email

  lineke.zuurman@bayer.com

• Sponsor organisation

  Bayer Consumer Care AG

• Eudract number

  2021-000059-38

• Clinicaltrials.gov Identifier

  NCT03556202

• Research summary

  Hot flushes are caused by the hormonal changes that happen when a woman’s body has been through the menopause. This decline in hormone production can lead to various symptoms which can have a very adverse effect on a menopausal woman's quality of life.
  The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flushes. There are treatments for hot flushes in women who have been through the menopause, but may cause side effects.
  In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flushes. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To compare these study treatments, the participants will record information about their hot flushes in an electronic diary. The researchers will study the number of hot flushes the participants have and how severe they are. They will study the results from before treatment and after 12 weeks of treatment.
  Study participants will take two capsules of either elinzanetant or the placebo once a day. The participants will take the study treatments for 52 weeks.
  During the study, the participants will visit their study site approximately 11 times and perform 2 visits by phone. Each participant will be in the study for approximately 62 weeks. During the study, the participants will:
  • record information about their hot flushes in an electronic diary
  • answer questions about their symptoms
  The doctors will:
  • check the participants’ health
  • take blood samples
  • ask the participants questions about what medicines they are taking and if they are having adverse events

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  21/EE/0246

• Date of REC Opinion

  25 Nov 2021

• REC opinion

  Further Information Favourable Opinion