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Neurokinin Antagonist

Elinzanetant for Hot Flashes (OASIS-1 Trial)

Phase 3
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 baseline to week 26
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new medication called elinzanetant to help women who have hot flashes after menopause. The medication works by blocking signals that cause hot flashes. Researchers will track the number and severity of hot flashes over time.

Eligible Conditions
  • Hot flashes
  • Hot Flush
  • Hot Flashes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Mean change in BDI-II total score from baseline to Week 26
Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12
Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12
+1 more

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)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Elinzanetant (BAY3427080)Experimental Treatment1 Intervention
Participants will receive 120 mg elinzanetant orally once daily for 26 weeks.
Group II: Placebo + elinzanetantPlacebo Group2 Interventions
Participants will receive matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elinzanetant (BAY3427080)
2022
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,274 Previous Clinical Trials
25,531,985 Total Patients Enrolled

Media Library

Elinzanetant (Neurokinin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05042362 — Phase 3
Hot Flush Research Study Groups: Elinzanetant (BAY3427080), Placebo + elinzanetant
Hot Flush Clinical Trial 2023: Elinzanetant Highlights & Side Effects. Trial Name: NCT05042362 — Phase 3
Elinzanetant (Neurokinin Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05042362 — Phase 3
~95 spots leftby Nov 2025
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