Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385795
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-15
Brief Title:
A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause
Sponsor:
Noema Pharma AG
Organization:
Noema Pharma AG
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:
RECRUITING
Status Verified Date:
2024-05
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 safetytolerability 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 safetytolerability 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:
None
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?:
None
Is an FDA AA801 Violation?:
None