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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sleep Disturbances Associated With Menopause

In brief

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 facts

Study ID

NCT06112756

Run by

Bayer

People needed

110

Starts

2023-11-08

Expected to finish

2024-11-07

Last updated by the study team

2025-11-10

Who can join

Age: 40 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• 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
• 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 — Móstoles, Spain
• Hospital Universitario de Araba | Santiago Campus - Unidad Sueno — Vitoria-Gasteiz, Spain
• 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 — Bad Dürrnberg, State of 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
• Siteworks - Zentrum für klinische Studien Hannover — Hanover, Lower Saxony, Germany
• Klinische Forschung Dresden | Dresden, Germany — Dresden, Saxony, 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 — Warsaw, Poland

Full record on ClinicalTrials.gov

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