EICHORCondition: Sleep Disturbances Associated With Menopause · Sponsor: Bayer
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…
This description comes directly from the study's public registry record.
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| Preferred Research Partners | Little Port Walter, Alaska, United States | — |
| MomDoc Women's Health Research | Scottsdale, AZ | Scottsdale, Arizona, 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 | — |
+ 28 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06112756