← Back to Search

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
Moderate to severe hot flash (HF) associated with the menopause and seeking treatment for this condition
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 26
Awards & highlights

OASIS-1 Trial Summary

This trial is studying a better way to treat women who have hot flashes after menopause.

Eligible Conditions
  • Hot Flashes

OASIS-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are experiencing strong and frequent hot flashes due to menopause and are actively looking for treatment.

OASIS-1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])
Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
+1 more
Secondary outcome measures
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 frequency of moderate to severe HF from baseline over time
+3 more

Side effects data

From 2019 Phase 2 trial • 199 Patients • NCT03596762
12%
Diarrhoea
12%
Nausea
12%
Herpes zoster
12%
Headache
6%
Bradycardia
6%
Nephrolithiasis
6%
Fatigue
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)
40 mg Elinzanetant (BAY3427080)
Placebo
160 mg Elinzanetant (BAY3427080)

OASIS-1 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
~1870

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,229 Previous Clinical Trials
25,325,041 Total Patients Enrolled
13 Trials studying Hot Flashes
3,208 Patients Enrolled for Hot Flashes

Media Library

Elinzanetant (Neurokinin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05042362 — Phase 3
Hot Flashes Research Study Groups: Elinzanetant (BAY3427080), Placebo + elinzanetant
Hot Flashes 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

Frequently Asked Questions

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

How many research facilities are in charge of this experiment?

"Among other locations, this study is occurring at Essential Women's Health Associates in Las Vegas, Nevada, Investigators Research Group, LLC in Brownsburg, Indiana, and Maximos Ob/Gyn in League City, Texas."

Answered by AI

How can I enroll myself in this research project?

"This trial is looking for 370 patients that are experiencing hot flashes and are between 40-65 years old. Additionally, the potential participants must have completed the Hot Flash Daily Diary for at least 11 days in the two weeks before the baseline visit. They must also have recorded at least 50 moderate or severe hot flashes in the last 7 days of the HFDD."

Answered by AI

Are people still being taken on as participants for this research project?

"Yes, the data on clinicaltrials.gov indicates that this study is actively searching for candidates. The trial was initially posted on 8/27/2021 and was last updated on 10/31/2022. The study is searching for 370 patients at 58 locations."

Answered by AI

Are elderly patients being accepted for this clinical trial?

"The minimum age requirement for this study is 40 years old and the maximum is 65 years old."

Answered by AI

What kind of health risks are associated with taking Elinzanetant?

"Elinzanetant (BAY3427080) is in Phase 3 of clinical trials, which means that there is both some efficacy data and multiple rounds of safety data. Therefore, it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Georgia
Texas
Other
How old are they?
18 - 65
What site did they apply to?
St. Vincent's Hospital - Birmingham
Houston Center for Clinical Research, LLC
Paramount Research Solutions-College Park
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I haven’t done anything. I’m having hot flashes… looking for treatment.. and the location is very close to my home.
PatientReceived 2+ prior treatments
~111 spots leftby Mar 2025