Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2025-12-31 @ 3:55 AM
Study NCT ID:
NCT06385795
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause
Sponsor:
Noema Pharma AG
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: