check_circleStudy Completed

Sleep disturbances associated with menopause

Bayer Identifier:

22423

ClinicalTrials.gov Identifier:

NCT06112756

EudraCT Number:

Not Available

EU CT Number:

2023-504955-28-00
A study to learn about how elinzanetant works and how safe it is in women having sleep disturbances associated with menopause

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

40 - 65 Years
  • - 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).
  • - 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 summary

Enrollment Goal
110
Trial Dates
November 2023 - November 2024
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Elinzanetant (BAY3427080)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sleep Therapy and Research Center | Medical Center Drive OfficeSan Antonio, 78229, United States
Withdrawn
Clinical Neurophysiology ServicesSterling Heights, 48314, United States
Withdrawn
CSMA - SugarlandSugar Land, 77478, United States
Withdrawn
Herz Jesu KrankenhausVienna, 1030, Austria
Withdrawn
LKH Graz II, Standort SüdGraz, 8053, Austria
Withdrawn
RudolfinerhausVienna, 1190, Austria
Completed
EMCO PrivatklinikBad Duerrnberg, 5422, Austria
Completed
SOMNI BENE INSTITUT FUR MEDIZIMISCHE FORSCHUNG & SCHLAFMEDEZIN SchwerinSchwerin, 19053, Germany
Completed
ADVANCED SLEEP RESEARCH BERLIN BerlinBerlin, 10117, Germany
Completed
Siteworks – Zentrum für klinische Studien HannoverHannover, 30449, Germany
Withdrawn
Centrum Badan Klinicznych PI-HouseGdansk, 80-546, Poland
Active, not recruiting
EMC Instytut Medyczny SAWroclaw, 50-220, Poland
Active, not recruiting
Osrodek Medycyny Snu Instytutu Psychiatrii i NeurologiiWarszawa, 02-957, Poland
Active, not recruiting
Hospital Clinico San Carlos | Neurophysiology Department - Sleep Unit - Menopause Sleep DisturbanceMadrid, 28040, Spain
Completed
Centro Medico Teknon | Unidad de Medicina del SuenoBarcelona, 08017, Spain
Completed
Hospital Universitario HM Puerta Del Sur | Departamento de Ensayos Clinicos - Sleep Unit - Menopause Sleep DisturbanceMostoles, 28938, Spain
Withdrawn
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Active, not recruiting
Hospital Universitario de Araba | Santiago Campus - Unidad SuenoVitoria-Gasteiz, 01009, Spain
Completed
Hospital Universitario de La Ribera | Neurophysiology and Sleep DepartmentAlzira, 46600, Spain
Withdrawn
AmphiaBreda, 4818 CK, Netherlands
Withdrawn
Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózyOlomouc, 77900, Czech Republic
Completed
Clinilabs Drug Development Corporation-FeasibilityEatontown, 07724, United States
Completed
Národní ústav duševního zdravíKlecany, 250 67, Czech Republic
Withdrawn
Universitätsklinik Gießen und Marburg GmbHMarburg, 35033, Germany
Completed
Palm Beach Research centerWest Palm Beach, 33409, United States
Withdrawn
Ohio Sleep Medicine InstituteDublin, 43017, United States
Completed
PharmaDev Clinical Research Institute, LLCMiami, 33176, United States
Completed
CTI Clinical Research CenterCincinnati, 45212, United States
Active, not recruiting
Intrepid Research, LLC.Cincinnati, 45245, United States
Withdrawn
NEUROTRIALS RESEARCH INC AtlantaAtlanta, 30342, United States
Withdrawn
Renstar Medical ResearchOcala, 34470, United States
Completed
Bogan Sleep Consultants, LLCColumbia, 29201, United States
Withdrawn
Santa Monica Clinical Trials Los AngelesLos Angeles, 90025, United States
Withdrawn
Meris Clinical ResearchBrandon, 33511, United States
Withdrawn
Pacific Research NetworkSan Diego, 92103, United States
Completed
Preferred Research PartnersLittle Rock, 72211, United States
Completed
Sleep Practitioners, LLCMacon, 31210, United States
Active, not recruiting
FutureSearch Trials of Neurology LPAustin, 78731, United States
Withdrawn
FutureSearch Trials of Dallas, LLCDallas, 75231, United States
Completed
Brengle Family MedicineIndianapolis, 46260, United States
Withdrawn
Medical University of South Carolina - Institute of PsychiatryCharleston, 29425, United States
Withdrawn
Rocky Mountain Clinical ResearchIdaho Falls, 83404, United States
Completed
Road Runner Research, Ltd.San Antonio, 78249, United States
Completed
SleepCare Research Institute IncStockbridge, 30281, United States
Completed
Anima Research CenterAlken, 3570, Belgium
Completed
Pneumocare SRLErpent, 5101, Belgium
Completed
Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Sleep CentreLeuven, 3000, Belgium
Withdrawn
CHU Saint-Pierre/UMC Sint-PieterBRUXELLES - BRUSSEL, 1000, Belgium
Completed
SGS CPUEdegem, 2650, Belgium
Withdrawn
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-LucBrussels, 1200, Belgium
Withdrawn
St. Francis Medical InstituteClearwater, 33765, United States
Withdrawn
NEUROLOGICAL CENTER OF N GAGainesville, 30501, United States
Completed
Segal Trials - Women's Health & General Medicine Research SiteNorth Miami, 33161, United States
Completed
Pacific Clinical Research Management Group LLCUpland, 91786, United States
Completed
Klinische Forschung Dresden | Dresden, GermanyDresden, 01069, Germany
Withdrawn
NeuroScience Research CenterCanton, 44718, United States
Not yet recruiting
KLIN FORSCHUNG HAMBURG GMBH HamburgHamburg, 20253, Germany
Completed
Diagnamics | Encinitas, CAEncinitas, 92024, United States
Completed
Essential Women’s Health AssociatesLas Vegas, 89113, United States
Completed
Helix Biomedics LLC | Boynton Beach, FLBoynton Beach, 33435, United States
Completed
Sweet Hope Research Specialty, Inc. - HialeahHialeah, 33016, United States
Completed
Revive Research Institute, Inc. - Women's HealthDearborn Heights, 48127, United States
Active, not recruiting
MomDoc Women's Health Research | Scottsdale, AZScottsdale, 85251, United States
Completed
SDS Clinical Trials IncSanta Ana, 92705, United States
Withdrawn
emovis GmbHBerlin, 10629, Germany

Primary Outcome

  • Change from baseline in WASO as measured by PSG
    WASO: Wakefulness after sleep onset – total number of minutes that a participant is awake after having initially fallen asleep. PSG assessments will be performed on 2 consecutive nights.
    date_rangeTime Frame:
    At Week 4

Secondary Outcome

  • Change from baseline in WASO as measured by PSG
    WASO: Wakefulness after sleep onset – total number of minutes that a participant is awake after having initially fallen asleep. PSG assessments will be performed on 2 consecutive nights.
    date_rangeTime Frame:
    At Week 12
  • Change from baseline in SE as measured by PSG
    SE: Sleep Efficiency – ratio between the total time a participant is asleep (TST) to the total time spent in bed. Presented as a percentage.
    date_rangeTime Frame:
    At Week 4
  • Change from baseline in SE as measured by PSG
    SE: Sleep Efficiency – ratio between the total time a participant is asleep (TST) to the total time spent in bed. Presented as a percentage.
    date_rangeTime Frame:
    At Week 12
  • Change from baseline in PROMIS SD SF 8b total score
    PROMIS SD SF 8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b. The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
    date_rangeTime Frame:
    At Week 4
  • Change from baseline in PROMIS SD SF 8b total score
    PROMIS SD SF 8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b. The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
    date_rangeTime Frame:
    At Week 12
  • Change from baseline in ISI total score
    ISI: Insomnia Severity Index. The ISI is a 7 item instrument that quantifies the participant perception of insomnia severity, along with the impact of insomnia on daytime functioning in adults in the last 2 weeks. The items refer to: severity of sleep onset, sleep maintenance and early morning wakening problems, satisfaction with sleep pattern, noticeability of sleep problems by others, distress caused by the sleep difficulties and interference of sleep difficulties with daytime functioning. It is scored on a 5 point Likert scale from 0 to 4 depending on the item (0=”none”, 4=”very severe” (Items 1–3); 0=”very satisfied”, 4=”very dissatisfied (Item 4)”; 0=”not at all noticeable”, 4=”very much noticeable” (Item 5); 0=”not at all worried”, and 4=”very much worried” (Item 6); 0=”not at all interfering”, 4=”very much interfering” (Item 7)). The scores for each item are summed to produce the total score (maximum 28), higher scores indicates greater severity.
    date_rangeTime Frame:
    At Week 4
  • Change from baseline in ISI total score
    ISI: Insomnia Severity Index. The ISI is a 7 item instrument that quantifies the participant perception of insomnia severity, along with the impact of insomnia on daytime functioning in adults in the last 2 weeks. The items refer to: severity of sleep onset, sleep maintenance and early morning wakening problems, satisfaction with sleep pattern, noticeability of sleep problems by others, distress caused by the sleep difficulties and interference of sleep difficulties with daytime functioning. It is scored on a 5 point Likert scale from 0 to 4 depending on the item (0=”none”, 4=”very severe” (Items 1–3); 0=”very satisfied”, 4=”very dissatisfied (Item 4)”; 0=”not at all noticeable”, 4=”very much noticeable” (Item 5); 0=”not at all worried”, and 4=”very much worried” (Item 6); 0=”not at all interfering”, 4=”very much interfering” (Item 7)). The scores for each item are summed to produce the total score (maximum 28), higher scores indicates greater severity.
    date_rangeTime Frame:
    At Week 12
  • Number of participants with Treatment-emergent Adverse Events (TEAEs)
    date_rangeTime Frame:
    Up to 16 weeks
  • Number of participants with Abnormal laboratory parameters
    date_rangeTime Frame:
    Up to 13 weeks

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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