A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)
Condition: Vasomotor Symptoms Associated With Menopause; Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 3

Summary: 
      Researchers are looking for a better way to treat women who have hot flashes after women have
      been through the menopause. Hot flashes are caused by the hormonal changes that happen when a
      woman's body has been through the menopause. Menopause is when women stop having a menstrual
      cycle, also called a period. During the menopause, the ovaries increasingly produce less sex
      hormones as a result of the natural ageing process and related hormonal adjustments. The
      decline in hormone production can lead to various symptoms which, in some cases, 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 flashes. There are treatments
      for hot flashes in women who have been through the menopause, but may cause medical problems
      for some people.

      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 flashes. A placebo looks like a
      treatment but does not have any medicine in it. To compare these study treatments, the
      doctors will ask the participants to record information about the participants' hot flashes
      in an electronic diary. The researchers will study the number of hot flashes the participants
      have and how severe the hot flashes are. The researchers will look at the results from before
      treatment, after 4 weeks, and after 12 weeks of treatment.

      The participants in this study will take two capsules of either elinzanetant or the placebo
      once a day. The participants who take elinzanetant will take it for 26 weeks. The
      participants who take the placebo will take it for 12 weeks and then take elinzanetant for
      the next 14 weeks.

      During the study, the participants will visit the site approximately 9 times and perform 1
      visit by phone. Each participant will be in the study for approximately 36 weeks. The
      treatment duration will be 26 weeks.

      During the study, the participants will:

        -  record information about the participants' hot flashes in an electronic diary

        -  answer questions about the participants' symptoms

      The doctors will:

        -  check the participants' health

        -  take blood samples

        -  ask the participants questions about what medicines the participants are taking and if
           the participants are having adverse events An adverse event is any medical problem that
           a participant has during a study. Doctors keep track of all adverse events that happen
           in studies, even if doctors do not think the adverse events might be related to the
           study treatments.
    


Intervention name(s): Elinzanetant (BAY3427080); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 120 mg elinzanetant orally once daily; Matching placebo orally once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopause