A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
NCT ID: NCT06112756
Last Updated: 2025-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2023-11-08
2024-11-07
Brief Summary
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Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a common and bothersome symptom associated with menopause that affects women's quality of life.
The study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause. It may block the activity of a protein that has been found to contribute to sleep disturbances.
The main purpose of this study is to learn how does elinzanetant affect sleep disturbances associated with menopause as measured on a sleep test called polysomnography (PSG) as compared with placebo.
For this, the researchers will analyze
* change in the total number of minutes a participant wakes up at night after going to sleep after 4 weeks of treatment compared to before treatment
* change in the total number of minutes a participant wakes up at night after going to sleep after 12 weeks of treatment compared to before treatment
* change in the participant's total time asleep while in bed after 4 and 12 weeks of treatment compared to before treatment.
The study participants will be randomly (by chance) assigned to one of two treatment groups. Dependent on the group, they will take elinzanetant or placebo for 12 weeks.
Each participant will be in the study for approximately 22 weeks (plus potential washout period), including a screening phase of up to 6 weeks, 12 weeks of treatment, and a follow up phase of 4 weeks after the end of treatment. 5 visits to the study site are planned.
During the study, the doctors and their study team will:
* take blood and urine samples
* do physical examinations
* check vital signs
* do sleep tests
* use an electronic hand-held device to record sleep quality and hot flashes at home
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Elinzanetant arm
Participants will take Elinzanetant
Elinzanetant
Oral
Placebo arm
Participants will take elinzanetant matching placebo
Placebo
Oral
Interventions
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Elinzanetant
Oral
Placebo
Oral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
65 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Preferred Research Partners
Little Port Walter, Alaska, United States
MomDoc Women's Health Research | Scottsdale, AZ
Scottsdale, Arizona, United States
Diagnamics | Encinitas, CA
Encinitas, California, United States
SDS Clinical Trials Inc
Santa Ana, California, United States
Pacific Clinical Research Management Group LLC
Upland, California, United States
Helix Biomedics LLC | Boynton Beach, FL
Boynton Beach, Florida, United States
Sweet Hope Research Specialty, Inc. - Hialeah
Hialeah, Florida, United States
PharmaDev Clinical Research Institute, LLC
Miami, Florida, United States
Segal Trials - Women's Health & General Medicine Research Site
North Miami, Florida, United States
Palm Beach Research center
West Palm Beach, Florida, United States
Sleep Practitioners, LLC
Macon, Georgia, United States
SleepCare Research Institute Inc
Stockbridge, Georgia, United States
Brengle Family Medicine
Indianapolis, Indiana, United States
Revive Research Institute, Inc. - Women's Health
Dearborn Heights, Michigan, United States
Essential Women's Health Associates
Las Vegas, Nevada, United States
Clinilabs Drug Development Corporation-Feasibility
Eatontown, New Jersey, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Intrepid Research, LLC.
Cincinnati, Ohio, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
FutureSearch Trials of Neurology LP
Austin, Texas, United States
Sleep Therapy and Research Center | Medical Center Drive Office
San Antonio, Texas, United States
Road Runner Research, Ltd.
San Antonio, Texas, United States
EMCO Privatklinik
Bad Dürrnberg, Salzburg, Austria
Anima Research Center
Alken, , Belgium
SGS CPU
Edegem, , Belgium
Pneumocare SRL
Erpent, , Belgium
Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Sleep Centre
Leuven, , Belgium
Národní ústav duševního zdraví
Klecany, , Czechia
Siteworks - Zentrum für klinische Studien Hannover
Hanover, Lower Saxony, Germany
Klinische Forschung Dresden | Dresden, Germany
Dresden, Saxony, Germany
ADVANCED SLEEP RESEARCH BERLIN Berlin
Berlin, , Germany
KLIN FORSCHUNG HAMBURG GMBH Hamburg
Hamburg, , Germany
SOMNI BENE INSTITUT FUR MEDIZIMISCHE FORSCHUNG & SCHLAFMEDEZIN Schwerin
Schwerin, , Germany
Osrodek Medycyny Snu Instytutu Psychiatrii i Neurologii
Warsaw, , Poland
EMC Instytut Medyczny SA
Wroclaw, , Poland
Hospital Universitario de La Ribera | Neurophysiology and Sleep Department
Alzira, , Spain
Centro Medico Teknon | Unidad de Medicina del Sueno
Barcelona, , Spain
Hospital Clinico San Carlos | Neurophysiology Department - Sleep Unit - Menopause Sleep Disturbance
Madrid, , Spain
Hospital Universitario HM Puerta Del Sur | Departamento de Ensayos Clinicos - Sleep Unit - Menopause Sleep Disturbance
Móstoles, , Spain
Hospital Universitario de Araba | Santiago Campus - Unidad Sueno
Vitoria-Gasteiz, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards
US sites only: Click here for contact
Other Identifiers
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2023-504955-28-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
22423
Identifier Type: -
Identifier Source: org_study_id