A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause

Inclusion Criteria:

• Capable of giving signed informed consent as described in study protocol whichincludes compliance with the requirements and restrictions listed in the InformedConsent Form.

• Female 45 years to 60 years of age inclusive, at the time of signing the InformedConsent Form

• Women who have experienced changes in menstrual cycle frequency or duration, and/orsymptoms that are indicative of menopausal transition, as determined by theinvestigator

• Greene climacteric scale (GCS) total score > 20 and GCS subscore for VMS ≥ 3

• Over the 10 days prior to enrolment (during the Screening Period), subject has aminimum of 7 to 8 moderate to severe hot flashes (VMS) per day, or 50 to 60 per week

• Body weight > 50 kg; Body Mass Index (BMI) within the range 17.5 to 40.0 kg/m2 (inclusive)

Exclusion Criteria:

• Clinically overt alcohol or drug use disorder (including use ofcannabis/cannabinoids within 4 weeks prior to Screening).

• History of psychiatric diagnoses (schizophrenia, schizoaffective,obsessive-compulsive disorder, bipolar disorder, or Attention Deficit/hyperactivityDisorder(ADHD)

• Current episode of major depression with Hamilton Rating Scale for Depression (HAM-D-17) score ≥ 17 [to be calculated as a subscore of the Structured interviewguide for the Hamilton depression scale with atypical depression supplement [SIGH-ADS]

• Prior or current history of a malignant tumor, except for basal cell carcinoma inremission

• Participants with a current history of significant cardiovascular, pulmonary,gastrointestinal, renal, hepatic, metabolic, hematological, immunological, orneurological disease that, in the opinion of the investigator or medical monitor,could compromise either the patient's safety or the results of the study

• Participant has abnormal findings identified during the Screening Periodassessments, including neurological and physical examinations, hematology andbiochemistry parameters, pulse rate and/or blood pressure and electrocardiogram (ECG), as compared with the appropriate reference ranges; if judged not clinicallysignificant, the PI should document this fact appropriately

• History of unexplained uterine bleeding or endometrial hyperplasia

• History of acute angle closure glaucoma

• History of cardiovascular disease including: a) Uncontrolled hypertension (systolic Blood Pressure (BP) > 165 mmHg or diastolicBlood Pressure > 100 mmHg) b) History of myocardial infarction, cardiac arrhythmia (other than sinus arrhythmia) c) Patients with a 12-lead Electrocardiogram (ECGdemonstrating either of the following: QT interval corrected for heart rateaccording to Fridericia's formula (QTcF) ≥ 470 msec (average of 3 Electrocardiograms (ECGs) obtained at the Screening Visit and assessed by central reader) QRS interval > 120 msec at the Screening Visit (local reading) Arrhythmia (other than sinusarrhythmia), conduction abnormalities (Atrioventricular block Grade 1 is allowed)

• Patients who express suicidal ideation or have recent history of suicidal behaviorand who, in the opinion of the investigator, are at risk of harming themselves