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Neurokinin Antagonist

Elinzanetant (BAY3427080) for Hormone Imbalance Syndrome

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 120 hours
Awards & highlights

Study Summary

This trial is being done to see if elinzanetant is a safe and effective treatment for vasomotor symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 120 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 120 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound)
Maximum observed (unbound) drug concentration (Cmax,u)
Secondary outcome measures
Number of participants with treatment-emergent adverse events, categorized by severity

Side effects data

From 2019 Phase 2 trial • 199 Patients • NCT03596762
12%
Diarrhoea
12%
Nausea
12%
Herpes zoster
12%
Headache
6%
Bradycardia
6%
Fatigue
6%
Nephrolithiasis
6%
Abdominal pain upper
6%
Aspartate aminotransferase increased
6%
Rash
6%
Haematuria
6%
Flatulence
6%
Non-cardiac chest pain
6%
Viral upper respiratory tract infection
6%
Viral sinusitis
6%
Blood creatine phosphokinase increased
6%
Electrocardiogram QT prolonged
6%
Liver function test increased
6%
Joint swelling
6%
Somnolence
6%
Depressed mood
6%
Insomnia
6%
Breast tenderness
6%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
80 mg Elinzanetant (BAY3427080)
120 mg Elinzanetant (BAY3427080)
Placebo
40 mg Elinzanetant (BAY3427080)
160 mg Elinzanetant (BAY3427080)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Severe renal impairmentExperimental Treatment1 Intervention
Participants with eGFR < 30 mL/min/ 1.73 m^2
Group II: Normal renal functionExperimental Treatment1 Intervention
Participants with ≥ 90 mL/min/1.73 m^2
Group III: Moderate renal impairmentExperimental Treatment1 Intervention
Participants with estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m^2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elinzanetant (BAY3427080)
2022
Completed Phase 3
~1870

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,947 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally
2021. "A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05071729.
~9 spots leftby Apr 2025
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