NCT06385795

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

A Phase 2a, 4-Week, Single Arm, Open-label, Multi-center Study to Assess Safety, Tolerability, and Preliminary Efficacy of NOE-115 in Women With Vasomotor Symptoms Due to Menopause

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Noema Pharma AG · Industry
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-center study to evaluate the effect of NOE-115, a monoamine modulator, in patients with moderate to severe vasomotor symptoms (hot flashes) due to menopause. Women will participate in the study for a total of approximately 12 weeks, comprising a screening period (4 weeks), treatment period (4 weeks), and a follow up period (4 weeks). The study is single arm but enrollment will occur in two cohorts. In Cohort, enrolled women will receive NOE-115 at a daily Dose A for the entire 4-week treatment period. Cohort 1 participants will return to the clinic on specified days per protocol for tolerability assessments. Cohort 2 will enroll participants after the acceptable safety/tolerability of NOE-115 Dose A has been determined from Cohort 1. Administration of NOE-115 will start on Study Day 1 and will continue daily for 4 weeks and will start at Dose A of NOE-115 as defined by the study protocol. Participants will receive NOE-115 up to a maximum- daily dose based on Investigator decision. Cohort 2 participants will return to the clinic on specified days per protocol for tolerability assessments and possible dose increases of NOE-115.

Conditions

• Menopause Syndrome
• Menopause
• Hot Flashes

Interventions

Type	Name	Description
DRUG	NOE-115	NOE-115 is an investigational monoamine modulator which has potential anti-inflammatory activity.

Timeline

• Start date: 2024-04-22
• Primary completion: 2025-08-13
• Completion: 2025-08-13
• First posted: 2024-04-26
• Last updated: 2025-09-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study