Sleep Disturbances Associated With MenopausePhase 2NIRVANANCT06112756
A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
A Phase 2 study testing Elinzanetant in people with Sleep Disturbances Associated With Menopause, run by Bayer at 40 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Sleep Disturbances Associated With Menopause
- What is being tested?
- Elinzanetant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 40 sitesin 7 countries
- Study dates
- 8 Nov 2023to 7 Nov 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
United States22 sites
FutureSearch Trials of Neurology LP
Austin, Texas, 78731
Helix Biomedics LLC | Boynton Beach, FL
Boynton Beach, Florida, 33435
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Intrepid Research, LLC.
Cincinnati, Ohio, 45245
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
Revive Research Institute, Inc. - Women's Health
Dearborn Heights, Michigan, 48127
Clinilabs Drug Development Corporation-Feasibility
Eatontown, New Jersey, 07724
Diagnamics | Encinitas, CA
Encinitas, California, 92024
Sweet Hope Research Specialty, Inc. - Hialeah
Hialeah, Florida, 33016
Brengle Family Medicine
Indianapolis, Indiana, 46260
Essential Women's Health Associates
Las Vegas, Nevada, 89113
Preferred Research Partners
Little Port Walter, Alaska, 72211
Sleep Practitioners, LLC
Macon, Georgia, 31210
PharmaDev Clinical Research Institute, LLC
Miami, Florida, 33176
Segal Trials - Women's Health & General Medicine Research Site
North Miami, Florida, 33161
Sleep Therapy and Research Center | Medical Center Drive Office
San Antonio, Texas, 78229
Road Runner Research, Ltd.
San Antonio, Texas, 78249
SDS Clinical Trials Inc
Santa Ana, California, 92705
MomDoc Women's Health Research | Scottsdale, AZ
Scottsdale, Arizona, 85251
SleepCare Research Institute Inc
Stockbridge, Georgia, 30281
Pacific Clinical Research Management Group LLC
Upland, California, 91786
Palm Beach Research center
West Palm Beach, Florida, 33409
Germany5 sites
ADVANCED SLEEP RESEARCH BERLIN Berlin
Berlin, 10117
Klinische Forschung Dresden | Dresden, Germany
Dresden, Saxony, 01069
KLIN FORSCHUNG HAMBURG GMBH Hamburg
Hamburg, 20253
Siteworks - Zentrum für klinische Studien Hannover
Hanover, Lower Saxony, 30449
SOMNI BENE INSTITUT FUR MEDIZIMISCHE FORSCHUNG & SCHLAFMEDEZIN Schwerin
Schwerin, 19053
Spain5 sites
Hospital Universitario de La Ribera | Neurophysiology and Sleep Department
Alzira, 46600
Centro Medico Teknon | Unidad de Medicina del Sueno
Barcelona, 08017
Hospital Clinico San Carlos | Neurophysiology Department - Sleep Unit - Menopause Sleep Disturbance
Madrid, 28040
Hospital Universitario HM Puerta Del Sur | Departamento de Ensayos Clinicos - Sleep Unit - Menopause Sleep Disturbance
Móstoles, 28938
Hospital Universitario de Araba | Santiago Campus - Unidad Sueno
Vitoria-Gasteiz, 01009
Belgium4 sites
Anima Research Center
Alken, 3570
SGS CPU
Edegem, 2650
Pneumocare SRL
Erpent, 5101
Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Sleep Centre
Leuven, 3000
Poland2 sites
Osrodek Medycyny Snu Instytutu Psychiatrii i Neurologii
Warsaw, 02-957
EMC Instytut Medyczny SA
Wroclaw, 50-220
About this study
Official title: 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.
Read more
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.
- Being tested
- Elinzanetant, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElinzanetantDrug
Oral
PlaceboOther
Oral
| Study group | Role | What they receive |
|---|---|---|
| Elinzanetant arm | Experimental | Participants will take Elinzanetant Receives: Drug: Elinzanetant |
| Placebo arm | Placebo comparator | Participants will take elinzanetant matching placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline until week 4
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline until week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start8 Nov 2023
- Primary completion22 Aug 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Disturbances Associated With MenopauseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112756
- Sponsor's protocol ID
- 22423
- Other IDs
- 2023-504955-28-00, 2023
- Acronym
- NIRVANA
- Status last verified
- Oct 2025
- First submitted
- 27 Oct 2023
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.