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

Completed · Phase 2

Conditions studied: Menopause Syndrome, Menopause, Hot Flashes

In brief

The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women.

Key facts

Study ID: NCT06385795
Run by: Noema Pharma AG
People needed: 40
Starts: 2024-04-22
Expected to finish: 2025-08-13
Last updated by the study team: 2025-09-12

Who can join

Age: 45 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Capable of giving signed informed consent as described in study protocol which includes compliance with the requirements and restrictions listed in the Informed Consent Form.
Female 45 years to 60 years of age inclusive, at the time of signing the Informed Consent Form
Women who have experienced changes in menstrual cycle frequency or duration, and/or symptoms that are indicative of menopausal transition, as determined by the investigator
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 a minimum 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)

You may not qualify if…

Clinically overt alcohol or drug use disorder (including use of cannabis/cannabinoids within 4 weeks prior to Screening).
History of psychiatric diagnoses (schizophrenia, schizoaffective, obsessive-compulsive disorder, bipolar disorder, or Attention Deficit/hyperactivity Disorder(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 interview guide for the Hamilton depression scale with atypical depression supplement [SIGH-ADS]
Prior or current history of a malignant tumor, except for basal cell carcinoma in remission
Participants with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological 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 Period assessments, including neurological and physical examinations, hematology and biochemistry parameters, pulse rate and/or blood pressure and electrocardiogram (ECG), as compared with the appropriate reference ranges; if judged not clinically significant, 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 diastolic Blood Pressure > 100 mmHg) b) History of myocardial infarction, cardiac arrhythmia (other than sinus arrhythmia) c) Patients with a 12-lead Electrocardiogram (ECG demonstrating either of the following: QT interval corrected for heart rate according 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 sinus arrhythmia), conduction abnormalities (Atrioventricular block Grade 1 is allowed)
Patients who express suicidal ideation or have recent history of suicidal behavior and who, in the opinion of the investigator, are at risk of harming themselves

Where it is running

Noema PMM-201 Site #104 — San Diego, California, United States
Noema PMM-201 Site #102 — Jacksonville, Florida, United States
Noema PMM-201 Site #101 — Atlanta, Georgia, United States
Noema PMM-201 Site #106 — Las Vegas, Nevada, United States
Noema PMM-201 Site #103 — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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