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Hormone Therapy

NOE-115 for Hot Flashes Due to Menopause

Phase 2
Recruiting
Research Sponsored by Noema Pharma AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight > 50 kg; Body Mass Index (BMI) within the range 17.5 to 40.0 kg/m2 (inclusive)
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
Must not have
History of acute angle closure glaucoma
History of unexplained uterine bleeding or endometrial hyperplasia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Summary

This trial aims to test if NOE-115 is safe and effective in reducing hot flashes in menopausal women with moderate to severe symptoms.

Who is the study for?
This trial is for women aged 45-60 who are experiencing moderate to severe hot flashes due to menopause. Participants must have had at least 7-8 daily hot flashes or 50-60 weekly, weigh over 50 kg with a BMI of 17.5-40, and be able to consent to the study's requirements.
What is being tested?
The study is testing NOE-115's safety, tolerability, and initial effectiveness in reducing menopausal vasomotor symptoms (hot flashes). Women will receive NOE-115 and their response to treatment will be monitored.
What are the potential side effects?
Potential side effects of NOE-115 are not detailed here but generally could include reactions where the medication is administered, hormonal changes, mood swings, or other symptoms related to altering body chemistry.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My weight is over 50 kg and my BMI is between 17.5 and 40.
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I've had 7-8 severe hot flashes daily or 50-60 weekly for the last 10 days.
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I am a woman aged between 45 and 60.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had acute angle closure glaucoma.
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I have had unexplained bleeding or thickening of my uterus lining.
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I have had cancer before, but it was not basal cell carcinoma or it is in remission.
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I have a history of serious heart issues or uncontrolled high blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Withdrawals Due to Adverse Events While on NOE-115 for Any Reason
Secondary outcome measures
Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4
Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs)
Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: NOE-115Experimental Treatment1 Intervention
Escalating doses of NOE-115 capsules

Find a Location

Who is running the clinical trial?

Noema Pharma AGLead Sponsor
5 Previous Clinical Trials
546 Total Patients Enrolled
Clinical Director, MDStudy DirectorNoema Pharma AG
2 Previous Clinical Trials
241 Total Patients Enrolled
~14 spots leftby Apr 2025
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