Understanding Elinzanetant’s role in Menopause-related Sleep Issues

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    What is this study about?

    The aim of this study is to investigate the use of a new drug called Elinzanetant for menopausal women who struggle with sleep problems. Menopause often causes sleep problems, such as waking up multiple times during the night, which can make life difficult. It may block proteins that cause sleep problems. The study will investigate whether Elinzanetant improves sleep compared with placebo. Researchers will look at how much time women spend awake after falling asleep at night and their total sleep time after 4 and 12 weeks of treatment. Women in the study will receive Elinzanetant or placebo for 12 weeks. The study will last approximately 22 weeks and includes check-ups including blood and urine tests, physical examinations, sleep tests and home recording of sleep quality and hot flashes. Any health problems that arise during the study will be recorded, whether they are related to the study drugs or not.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Bad Duerrnberg , Austria

      Graz , Austria

      Vienna , Austria

      Vienna , Austria

      Alken , Belgium

      Bruxelles – Brussel , Belgium

      Edegem , Belgium

      Erpent , Belgium

      Leuven , Belgium

      Woluwe Saint Lambert , Belgium

      Klecany , Czechia

      Olomouc , Czechia

      Marburg , Germany

      Hannover , Germany

      Dresden , Germany

      Berlin , Germany

      Hamburg , Germany

      Schwerin , Germany

      Breda , Netherlands

      Warsaw , Poland

      Wroclaw , Poland

      Alzira , Spain

      Barcelona , Spain

      Barcelona , Spain

      Madrid , Spain

      Mostoles , Spain

      Vitoria-Gasteiz , Spain

      You can join this study in:

      Belgium: Alken, Edegem, Leuven.

      Spain: Alzira, Barcelona, Madrid.

      Austria: Bad Dürrnberg, Graz, Vienna.

      Germany: Berlin, Dresden, Hamburg, Marburg, Schwerin.

      Netherlands: Breda.

      Czechia: Klecany, Olomouc.

      Poland: Warsaw, Wrocław.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take when participating in this clinical trial include:

      1. Taking blood and urine samples
      2. Undergoing physical examinations
      3. Having their vital signs checked
      4. Participating in sleep tests
      5. Using an electronic hand-held device to record sleep quality and hot flashes at home

      These procedures are part of the trial’s protocol to monitor the safety and efficacy of the study treatment.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have been diagnosed with one of the following diseases:

      1. Dyssomnias
      2. Parasomnias

      These diseases are both related to sleep-wake disorders.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      The conditions that you must meet to join the study, with explanations of medical terms, are as follows:

      1. Females aged 40 to 65 years, inclusive, at signing of informed consent. This means you must be a woman within this age range and be able to provide consent to participate in the clinical trial.
      2. Post-menopausal period, defined as:
        • Serum Follicle-Stimulating Hormone (FSH) levels >40 mIU/mL
        • A serum estradiol concentration of <30 pg/mL at screening
        • Hysterectomy performed at least 6 weeks prior to screening

        Here, serum FSH levels refer to the amount of follicle-stimulating hormone in your blood, which is a marker used to determine menopausal status. Serum estradiol concentration is the amount of estradiol (a form of estrogen) in your blood, which decreases after menopause. Hysterectomy is a surgical operation to remove all or part of the uterus.

      3. Ongoing sleep disturbances associated with menopause. You must have a self-reported sleep history that includes sleep problems linked to menopause, particularly waking up at night and/or having poor quality of sleep.
      4. WASO of 30 minutes or more. This condition refers to Wake After Sleep Onset, the amount of time spent awake after initially falling asleep. It is measured by polysomnography (PSG), which is a comprehensive sleep study used to diagnose sleep disorders. The requirement is that the mean of 2 screening PSGs shows a WASO of at least 30 minutes, with neither of the 2 nights being less than 20 minutes.

      Please note, these criteria are required to assess your eligibility for the study, and each one has specific medical significance pertaining to understanding the effects of the investigational drug on post-menopausal sleep disturbances.

      What Reasons Could Exclude Me from the Study?

      Here is a list of the exclusion criteria for the study, including explanations of medical terms where necessary:

      1. Sleep disorder diagnosis other than menopause-associated sleep disturbances:
        If you have a medical history or show a baseline polysomnography (PSG) assessment that includes a diagnosis of a sleep disorder other than the sleep disturbances associated with menopause, such as sleep apnea, restless leg syndrome, or circadian rhythm sleep disorder, you cannot participate.

        • Polysomnography (PSG): A comprehensive sleep study used to diagnose sleep disorders by recording brain waves, oxygen levels in the blood, heart rate, breathing, as well as eye and leg movements during sleep.
        • Sleep apnea: A serious sleep disorder that occurs when a person’s breathing is interrupted during sleep.
        • Restless leg syndrome: A condition characterized by a nearly irresistible urge to move the legs, typically in the evenings.
        • Circadian rhythm sleep disorder: A type of disorder that affects the timing of sleep, wakefulness, and other daily rhythms.
      2. Cancer history:
        If you currently have cancer, or if you have a history of any malignancy (except if you have been in complete remission for 5 years or more), except for basal and squamous cell skin tumors, you are not eligible to participate.

        • Malignancy: Another term for cancer, a disease in which abnormal cells divide uncontrollably and can invade nearby tissues or spread to other parts of the body.
        • Basal and squamous cell skin tumors: Types of skin cancer that are generally considered less dangerous than melanoma and can usually be treated effectively.
      3. Renal impairment greater than moderate:
        If you have a renal impairment greater than moderate, you cannot take part in the study.

        • Renal impairment: Reduced function of the kidneys, which may affect the body’s ability to clear waste products and regulate blood pressure, electrolytes, and red blood cell production.

      These criteria must be met to ensure the safety of participants and the validity of the study results.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical study involves the following drug:

      1. Elinzanetant (also called BAY 3427080) – Elinzanetant is under development to treat symptoms associated with menopause, such as hot flashes. It aims to block the activity of a protein that is believed to contribute to sleep disturbances.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substance being investigated in the clinical trial is:

      1. Elinzanetant (also called BAY 3427080): This substance is currently under development and is not yet known to medicine and the medical literature in terms of being an approved treatment. It is being studied for its potential to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause.

      Study ID

      CT-EU-00042122

      Recruitment status

      Recruting new patients

      Start of the trial

      7 months ago

      Study phase

      Phase
      II

      Medicinal Product