(22423 NIRVANA) 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 - 22423

Bayer Consumer Care AG0 个研究点目标入组 135 人开始时间: 2023年11月3日最近更新: 2024年8月21日

适应症

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•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, Abnormal liver parameters (presence of at least one of the following criteria): - AST >2 x ULN - ALT >2 x ULN - AP >2 x ULN - TBL >ULN unless explained by Gilbert’s syndrome - INR >ULN unless explained by, e.g., intake of anticoagulants - Diagnosis of hepatitis B infection, i.e., Hbs-antigen positive at screening - Diagnosis of hepatitis C infection, i.e., hepatitis C-antibodies and HCV-RNA positive at screening.

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