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Study on Elinzanetant for Treating Sleep Disturbances in Menopausal Women

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying sleep disturbances associated with menopause. The treatment being tested is a medication called elinzanetant, which is being compared to a placebo. The purpose of the study is to learn about how elinzanetant works and how safe it is for women experiencing sleep problems during menopause.

Participants in the study will be randomly assigned to receive either elinzanetant or a placebo. The study will last for several weeks, during which participants will take the medication in the form of a soft capsule. Throughout the study, participants will be monitored to assess any changes in their sleep patterns and overall well-being.

The study aims to explore the effectiveness of elinzanetant in improving sleep quality for women who are in the post-menopausal period. By the end of the study, researchers hope to gather valuable information on whether elinzanetant can help alleviate sleep disturbances associated with menopause.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, menopausal status, and sleep disturbance history.

    Participants must be females aged 40 to 65 years and in the post-menopausal period.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline sleep patterns using a method called PSG (polysomnography), which records sleep activity.

    Participants must have a WASO (wake after sleep onset) of 30 minutes or more.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive either elinzanetant or a placebo in the form of a soft capsule.

    The medication is taken orally.

  4. Step 4

    Treatment period

    The treatment period lasts for 12 weeks.

    Participants continue taking the assigned medication throughout this period.

  5. Step 5

    Follow-up assessments

    Follow-up assessments are conducted at Week 4 and Week 12 to measure changes in sleep patterns using PSG.

    Additional assessments include changes in sleep efficiency (SE) and scores from sleep-related questionnaires.

  6. Step 6

    Monitoring and safety checks

    Throughout the study, participants are monitored for any side effects or abnormal laboratory results.

    Safety is a priority, and any treatment-emergent adverse events (TEAEs) are recorded.

  7. Step 7

    Completion of study

    The study is estimated to end by January 7, 2025.

    Participants complete the study after the final assessment at Week 12.

Who can join the trial?

4 criteria

  • Females aged 40 to 65 years can participate.
  • Participants must be in the post-menopausal period. This means they should have certain hormone levels: serum FSH (a hormone related to reproduction) levels greater than 40 mIU/mL and serum estradiol (a form of estrogen) concentration less than 30 pg/mL. Additionally, if they have had a hysterectomy (surgical removal of the uterus), it should have been done at least 6 weeks before joining the study.
  • Participants should have a history of sleep problems related to menopause, such as waking up at night or having poor quality sleep.
  • Participants should have a WASO (Wake After Sleep Onset) of 30 minutes or more. This means that, on average, they are awake for at least 30 minutes after initially falling asleep, based on two sleep tests, with neither night being less than 20 minutes.

Who cannot join the trial?

4 criteria

  • Men who wish to participate, as the study is only for women.
  • Women who are not experiencing sleep disturbances associated with menopause.
  • Individuals who do not fall within the specified age range for the study.
  • Individuals who are part of a vulnerable population, which means groups that might need special protection or care.
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Investigated drugs

Elinzanetant is a medication being studied for its potential to help with sleep disturbances that occur during menopause. The trial aims to see how effective and safe this medication is for improving sleep quality in women experiencing menopause-related sleep issues.

What is already known about the treatment

Elinzanetant – Elinzanetant is administered orally and is currently being studied in clinical trials for its potential to treat sleep disturbances associated with menopause. It is in the Phase 2 stage of clinical trials, where its efficacy and safety are being compared to a placebo. The main therapeutic indication for elinzanetant is to alleviate sleep issues that occur during menopause. At the molecular level, elinzanetant works by modulating specific receptors in the brain that are involved in regulating sleep patterns. It is classified pharmacologically as a neurokinin receptor antagonist.

Investigated diseases

Sleep disturbances associated with menopause – This condition involves difficulties with sleep that occur during menopause, a natural phase in a woman's life when menstrual cycles end. Common symptoms include trouble falling asleep, staying asleep, or waking up too early. These disturbances are often linked to hormonal changes, particularly the decrease in estrogen levels. Women may experience night sweats and hot flashes, which can further disrupt sleep. The condition can lead to feelings of fatigue and irritability during the day. It is a common issue that affects many women going through menopause.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504955-28-01Protocol code22423Estimated enrolment135 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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