Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
40–65
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
