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

NCT06385795 | Completed Phase 2 FDA Drug

• 1 other identifier: NOE-PMM-201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

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

Menopause Syndrome; Menopause; Hot Flashes

Outcome Measures

Primary Outcomes (1)

• Withdrawals Due to Adverse Events While on NOE-115 for Any Reason

  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

  4 weeks

Secondary Outcomes (4)

• Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs)

  4 weeks

• Weekly Mean Change in the Severity of Hot Flashes from Baseline to Week 4

  4 weeks

• Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4

  4 weeks

• Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4

  4 weeks

Study Arms (1)

NOE-115

EXPERIMENTAL

Escalating doses of NOE-115 capsules

Drug: NOE-115

Interventions

NOE-115 DRUG

NOE-115 is an investigational monoamine modulator which has potential anti-inflammatory activity.

NOE-115

Eligibility Criteria

• Age: 45 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Noema Pharma AG: lead

Study Sites (5)

Noema PMM-201 Site #104

San Diego, California, 92111, United States

Location

Noema PMM-201 Site #102

Jacksonville, Florida, 32256, United States

Location

Noema PMM-201 Site #101

Atlanta, Georgia, 30030, United States

Location

Noema PMM-201 Site #106

Las Vegas, Nevada, 89106, United States

Location

Noema PMM-201 Site #103

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Director, MD

  Noema Pharma AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 26, 2024
• Study Start: April 22, 2024
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)