A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause

NCT06112756 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 224232023-504955-28-00
• Study Type: interventional
• Target: 110
• Locations: 7 countries
• Sites: 40

Brief Summary

Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause. 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.

Conditions

Sleep Disturbances Associated With Menopause

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG)

  WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on. Persistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset.

  From baseline until week 4

Secondary Outcomes (7)

• Change From Baseline in WASO at Week 12 as Measured by PSG

  From baseline until week 12

• Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG

  From baseline to Week 4

• Change From Baseline in SE at Week 12 as Measured by PSG

  From baseline to week 12

• Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 4

  From baseline until week 4

• Change From Baseline inPatient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 12

  From baseline until week 12

Study Arms (2)

Elinzanetant arm

EXPERIMENTAL

Participants will take Elinzanetant

Drug: Elinzanetant

Placebo arm

PLACEBO COMPARATOR

Participants will take elinzanetant matching placebo

Other: Placebo

Interventions

Elinzanetant DRUG

Oral

Elinzanetant arm

Placebo OTHER

Oral

Placebo arm

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (40)

Preferred Research Partners

Little Port Walter, Alaska, 72211, United States

Location

MomDoc Women's Health Research | Scottsdale, AZ

Scottsdale, Arizona, 85251, United States

Location

Diagnamics | Encinitas, CA

Encinitas, California, 92024, United States

Location

SDS Clinical Trials Inc

Santa Ana, California, 92705, United States

Location

Pacific Clinical Research Management Group LLC

Upland, California, 91786, United States

Location

Helix Biomedics LLC | Boynton Beach, FL

Boynton Beach, Florida, 33435, United States

Location

Sweet Hope Research Specialty, Inc. - Hialeah

Hialeah, Florida, 33016, United States

Location

PharmaDev Clinical Research Institute, LLC

Miami, Florida, 33176, United States

Location

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

North Miami, Florida, 33161, United States

Location

Palm Beach Research center

West Palm Beach, Florida, 33409, United States

Location

Sleep Practitioners, LLC

Macon, Georgia, 31210, United States

Location

SleepCare Research Institute Inc

Stockbridge, Georgia, 30281, United States

Location

Brengle Family Medicine

Indianapolis, Indiana, 46260, United States

Location

Revive Research Institute, Inc. - Women's Health

Dearborn Heights, Michigan, 48127, United States

Location

Essential Women's Health Associates

Las Vegas, Nevada, 89113, United States

Location

Clinilabs Drug Development Corporation-Feasibility

Eatontown, New Jersey, 07724, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Intrepid Research, LLC.

Cincinnati, Ohio, 45245, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

Location

FutureSearch Trials of Neurology LP

Austin, Texas, 78731, United States

Location

Sleep Therapy and Research Center | Medical Center Drive Office

San Antonio, Texas, 78229, United States

Location

Road Runner Research, Ltd.

San Antonio, Texas, 78249, United States

Location

EMCO Privatklinik

Bad Dürrnberg, Salzburg, 5422, Austria

Location

Anima Research Center

Alken, 3570, Belgium

Location

SGS CPU

Edegem, 2650, Belgium

Location

Pneumocare SRL

Erpent, 5101, Belgium

Location

Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Sleep Centre

Leuven, 3000, Belgium

Location

Národní ústav duševního zdraví

Klecany, 250 67, Czechia

Location

Siteworks - Zentrum für klinische Studien Hannover

Hanover, Lower Saxony, 30449, Germany

Location

Klinische Forschung Dresden | Dresden, Germany

Dresden, Saxony, 01069, Germany

Location

ADVANCED SLEEP RESEARCH BERLIN Berlin

Berlin, 10117, Germany

Location

KLIN FORSCHUNG HAMBURG GMBH Hamburg

Hamburg, 20253, Germany

Location

SOMNI BENE INSTITUT FUR MEDIZIMISCHE FORSCHUNG & SCHLAFMEDEZIN Schwerin

Schwerin, 19053, Germany

Location

Osrodek Medycyny Snu Instytutu Psychiatrii i Neurologii

Warsaw, 02-957, Poland

Location

EMC Instytut Medyczny SA

Wroclaw, 50-220, Poland

Location

Hospital Universitario de La Ribera | Neurophysiology and Sleep Department

Alzira, 46600, Spain

Location

Centro Medico Teknon | Unidad de Medicina del Sueno

Barcelona, 08017, Spain

Location

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

Madrid, 28040, Spain

Location

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

Móstoles, 28938, Spain

Location

Hospital Universitario de Araba | Santiago Campus - Unidad Sueno

Vitoria-Gasteiz, 01009, Spain

Location

Related Links

• 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

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 1, 2023
• Study Start: November 8, 2023
• Primary Completion: August 22, 2024
• Study Completion: November 7, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2); BE (4); US (22); AU (1); ES (5); CZ (1); DE (5)