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

What this trial studies

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.

Conditions in scope

• Menopause Syndrome
• Menopause
• Hot Flashes

Interventions

• NOE-115 (Drug) — NOE-115 is an investigational monoamine modulator which has potential anti-inflammatory activity.

Who can join

Women only · Ages 45 Years to 60 Years

Inclusion criteria

• 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)

Exclusion criteria

• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2024-04-22
• Primary completion: 2025-08-13
• Last update posted: 2025-09-12
• First posted: 2024-04-26

Sponsor & contact

Lead sponsor: Noema Pharma AG (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Withdrawals Due to Adverse Events While on NOE-115 for Any Reason (4 weeks)
  Occurrence of withdrawal from the study by the participant due to adverse event. An AE is defined as any unfavorable and untoward sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment that occurs during the course of the study

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.