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

Phase 2

Completed

• Conditions: Sleep Disturbances Associated With Menopause
• Interventions: Other: Placebo; Drug: Elinzanetant

• Registration Number: NCT06112756
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-01
• Study Start: 2023-11-08
• Primary Completion: 2024-08-22
• Study Completion: 2024-11-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo	Participants will take elinzanetant matching placebo
Elinzanetant arm	Elinzanetant	Participants will take Elinzanetant

Primary Outcome Measures

Name	Time	Method
Change from baseline in WASO as measured by PSG	At Week 4	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in WASO as measured by PSG	At Week 12	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.
Change from baseline in SE as measured by PSG	At Week 12	SE: Sleep Efficiency - ratio between the total time a participant is asleep (TST) to the total time spent in bed. Presented as a percentage.
Change from baseline in PROMIS SD SF 8b total score	At Week 12	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.
Change from baseline in ISI total score	At Week 12	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.
Number of participants with Treatment-emergent Adverse Events (TEAEs)	Up to 16 weeks
Number of participants with Abnormal laboratory parameters	Up to 13 weeks

Trial Locations

Locations (40)

Siteworks - Zentrum für klinische Studien Hannover; 🇩🇪 Hannover, Niedersachsen, Germany

MomDoc Women's Health Research | Scottsdale, AZ; 🇺🇸 Scottsdale, Arizona, United States

Preferred Research Partners; 🇺🇸 Little Rock, Arkansas, 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; 🇦🇹 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

Klinische Forschung Dresden | Dresden, Germany; 🇩🇪 Dresden, Sachsen, 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; 🇵🇱 Warszawa, 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; 🇪🇸 Mostoles, Spain

Hospital Universitario de Araba | Santiago Campus - Unidad Sueno; 🇪🇸 Vitoria-Gasteiz, Spain