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New pill could help menopausal women sleep through the night

NCT ID NCT06112756

Symptom relief Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called elinzanetant to see if it can reduce nighttime waking in menopausal women. About 110 women will take either the drug or a placebo for 12 weeks. Researchers will measure sleep quality using sleep tests and diaries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
elinzanetant
What this could lead to
If it works, this could lead to a new non-hormonal treatment for sleep problems during menopause.
What could go wrong
This is a small, early-phase study with only 110 participants. The drug may not improve sleep more than placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

110 people

The number who actually took part.

Started

Nov 2023

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Females aged 40 to 65 years, inclusive, at signing of informed consent. * Being in the post-menopausal period, defined as: serum FSH levels \>40 mIU/mL and a serum estradiol concentration of \<30 pg/mL at screening, AND Hysterectomy performed at least 6 weeks prior to screening. * The participant's self-reported sleep history includes ongoing sleep disturbances associated with menopause characterized by waking up at night and/or poor quality of sleep. * WASO of 30 minutes or more (mean of 2 screening PSGs with neither of the 2 nights \<20 min). Exclusion Criteria: * Medical history, or baseline PSG assessment, includes a diagnosis of a sleep disorder other than sleep disturbances associated with the menopause (e.g., sleep apnea, restless leg syndrome, circadian rhythm sleep disorder). * Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors). * Renal impairment greater than moderate (i.e. estimated glomerular filtration rate \<30 mL/min/1.73 m\^2) at screening

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep disturbances associated with menopause

Contacts and locations

Locations

  • ADVANCED SLEEP RESEARCH BERLIN Berlin

    Berlin, 10117, Germany

  • Anima Research Center

    Alken, 3570, Belgium

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina, 29201, United States

  • Brengle Family Medicine

    Indianapolis, Indiana, 46260, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Centro Medico Teknon | Unidad de Medicina del Sueno

    Barcelona, 08017, Spain

  • Clinilabs Drug Development Corporation-Feasibility

    Eatontown, New Jersey, 07724, United States

  • Diagnamics | Encinitas, CA

    Encinitas, California, 92024, United States

  • EMC Instytut Medyczny SA

    Wroclaw, 50-220, Poland

  • EMCO Privatklinik

    Bad Dürrnberg, State of Salzburg, 5422, Austria

  • Essential Women's Health Associates

    Las Vegas, Nevada, 89113, United States

  • FutureSearch Trials of Neurology LP

    Austin, Texas, 78731, United States

  • Helix Biomedics LLC | Boynton Beach, FL

    Boynton Beach, Florida, 33435, United States

  • Hospital Clinico San Carlos | Neurophysiology Department - Sleep Unit - Menopause Sleep Disturbance

    Madrid, 28040, Spain

  • Hospital Universitario HM Puerta Del Sur | Departamento de Ensayos Clinicos - Sleep Unit - Menopause Sleep Disturbance

    Móstoles, 28938, Spain

  • Hospital Universitario de Araba | Santiago Campus - Unidad Sueno

    Vitoria-Gasteiz, 01009, Spain

  • Hospital Universitario de La Ribera | Neurophysiology and Sleep Department

    Alzira, 46600, Spain

  • Intrepid Research, LLC.

    Cincinnati, Ohio, 45245, United States

  • KLIN FORSCHUNG HAMBURG GMBH Hamburg

    Hamburg, 20253, Germany

  • Klinische Forschung Dresden | Dresden, Germany

    Dresden, Saxony, 01069, Germany

  • MomDoc Women's Health Research | Scottsdale, AZ

    Scottsdale, Arizona, 85251, United States

  • Národní ústav duševního zdraví

    Klecany, 250 67, Czechia

  • Osrodek Medycyny Snu Instytutu Psychiatrii i Neurologii

    Warsaw, 02-957, Poland

  • Pacific Clinical Research Management Group LLC

    Upland, California, 91786, United States

  • Palm Beach Research center

    West Palm Beach, Florida, 33409, United States

  • PharmaDev Clinical Research Institute, LLC

    Miami, Florida, 33176, United States

  • Pneumocare SRL

    Erpent, 5101, Belgium

  • Preferred Research Partners

    Little Port Walter, Alaska, 72211, United States

  • Revive Research Institute, Inc. - Women's Health

    Dearborn Heights, Michigan, 48127, United States

  • Road Runner Research, Ltd.

    San Antonio, Texas, 78249, United States

  • SDS Clinical Trials Inc

    Santa Ana, California, 92705, United States

  • SGS CPU

    Edegem, 2650, Belgium

  • SOMNI BENE INSTITUT FUR MEDIZIMISCHE FORSCHUNG & SCHLAFMEDEZIN Schwerin

    Schwerin, 19053, Germany

  • Segal Trials - Women's Health & General Medicine Research Site

    North Miami, Florida, 33161, United States

  • Siteworks - Zentrum für klinische Studien Hannover

    Hanover, Lower Saxony, 30449, Germany

  • Sleep Practitioners, LLC

    Macon, Georgia, 31210, United States

  • Sleep Therapy and Research Center | Medical Center Drive Office

    San Antonio, Texas, 78229, United States

  • SleepCare Research Institute Inc

    Stockbridge, Georgia, 30281, United States

  • Sweet Hope Research Specialty, Inc. - Hialeah

    Hialeah, Florida, 33016, United States

  • Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Sleep Centre

    Leuven, 3000, Belgium

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