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

A Randomized, Parallel-group Treatment, Phase 2, Double-blind Pilot Study to Investigate the Efficacy and Safety of Elinzanetant Compared With Placebo for Treatment of Sleep Disturbances Associated With Menopause.

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disturbances Associated With Menopause
• Intervention / Treatment: Other: Placebo; Drug: Elinzanetant

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Salzburg
    • Bad Dürrnberg, Salzburg, Austria, 5422
      • EMCO Privatklinik
• Belgium
  • Alken, Belgium, 3570
    • Anima Research Center
  • Edegem, Belgium, 2650
    • SGS CPU
  • Erpent, Belgium, 5101
    • Pneumocare SRL
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Sleep Centre
• Czechia
  • Klecany, Czechia, 250 67
    • Narodni ustav dusevniho zdravi
• Germany
  • Berlin, Germany, 10117
    • ADVANCED SLEEP RESEARCH BERLIN Berlin
  • Hamburg, Germany, 20253
    • KLIN FORSCHUNG HAMBURG GMBH Hamburg
  • Schwerin, Germany, 19053
    • SOMNI BENE INSTITUT FUR MEDIZIMISCHE FORSCHUNG & SCHLAFMEDEZIN Schwerin
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30449
      • Siteworks - Zentrum fur klinische Studien Hannover
  • Saxony
    • Dresden, Saxony, Germany, 01069
      • Klinische Forschung Dresden | Dresden, Germany
• Poland
  • Warsaw, Poland, 02-957
    • Osrodek Medycyny Snu Instytutu Psychiatrii i Neurologii
  • Wroclaw, Poland, 50-220
    • EMC Instytut Medyczny SA
• Spain
  • Alzira, Spain, 46600
    • Hospital Universitario de La Ribera | Neurophysiology and Sleep Department
  • Barcelona, Spain, 08017
    • Centro Medico Teknon | Unidad de Medicina del Sueno
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos | Neurophysiology Department - Sleep Unit - Menopause Sleep Disturbance
  • Móstoles, Spain, 28938
    • Hospital Universitario HM Puerta Del Sur | Departamento de Ensayos Clinicos - Sleep Unit - Menopause Sleep Disturbance
  • Vitoria-Gasteiz, Spain, 01009
    • Hospital Universitario de Araba | Santiago Campus - Unidad Sueno
• United States
  • Alaska
    • Little Port Walter, Alaska, United States, 72211
      • Preferred Research Partners
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • MomDoc Women's Health Research | Scottsdale, AZ
  • California
    • Encinitas, California, United States, 92024
      • Diagnamics | Encinitas, CA
    • Santa Ana, California, United States, 92705
      • SDS Clinical Trials Inc
    • Upland, California, United States, 91786
      • Pacific Clinical Research Management Group LLC
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Helix Biomedics LLC | Boynton Beach, FL
    • Hialeah, Florida, United States, 33016
      • Sweet Hope Research Specialty, Inc. - Hialeah
    • Miami, Florida, United States, 33176
      • PharmaDev Clinical Research Institute, LLC
    • North Miami, Florida, United States, 33161
      • Segal Trials - Women's Health & General Medicine Research Site
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Macon, Georgia, United States, 31210
      • Sleep Practitioners, LLC
    • Stockbridge, Georgia, United States, 30281
      • SleepCare Research Institute Inc
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Brengle Family Medicine
  • Michigan
    • Dearborn Heights, Michigan, United States, 48127
      • Revive Research Institute, Inc. - Women's Health
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Essential Women's Health Associates
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Clinilabs Drug Development Corporation-Feasibility
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45245
      • Intrepid Research, LLC.
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants, LLC
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology LP
    • San Antonio, Texas, United States, 78249
      • Road Runner Research, Ltd.
    • San Antonio, Texas, United States, 78229
      • Sleep Therapy and Research Center | Medical Center Drive Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elinzanetant arm; Participants will take Elinzanetant	Drug: Elinzanetant; Oral
Placebo Comparator: Placebo arm; Participants will take elinzanetant matching placebo	Other: Placebo; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in WASO at Week 12 as Measured by 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 12
Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG	Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep.	From baseline to Week 4
Change From Baseline in SE at Week 12 as Measured by PSG	Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep.	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	Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.	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	Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.	From baseline until week 12
Change From Baseline in Insomnia Severity Index (ISI) Total Score at Week 4	Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference. Scoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28. Severity Categories: 0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores.	From baseline until week 4
Change From Baseline in ISI Total Score at Week 12	Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference. Scoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28. Severity Categories: 0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores.	From baseline until week 12

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Actual): August 22, 2024
• Study Completion (Actual): November 7, 2024

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 22423; 2023-504955-28-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No