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Neurokinin Antagonist

Elinzanetant (BAY3427080) for Hot Flashes

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

Study Summary

This trial is looking for a better way to treat women who have hot flashes after going through menopause. Elinzanetant is a new treatment that blocks a protein called neurokinin from sending signals to other parts of the body. The study will compare elinzanetant to a placebo in women who have been through the menopause and have hot flashes.

Eligible Conditions
  • 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

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%
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

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
2,237 Previous Clinical Trials
25,326,578 Total Patients Enrolled
13 Trials studying Hot Flashes
3,204 Patients Enrolled for Hot Flashes

Media Library

Elinzanetant (Neurokinin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05099159 — Phase 3
Hot Flashes Research Study Groups: Placebo + elinzanetant, Elinzanetant (BAY3427080)
Hot Flashes Clinical Trial 2023: Elinzanetant Highlights & Side Effects. Trial Name: NCT05099159 — Phase 3
Elinzanetant (Neurokinin Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05099159 — Phase 3
Hot Flashes Patient Testimony for trial: Trial Name: NCT05099159 — Phase 3

Frequently Asked Questions

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

How does Elinzanetant (BAY3427080) affect patients negatively?

"There is available clinical data that supports the safety of Elinzanetant (BAY3427080), so it received a score of 3."

Answered by AI

Are we still enrolling people for this research project?

"Yes, this study is still looking for participants. The listing on clinicaltrials.gov says that the trial was first posted on 2021-10-29 and updated on 31 October, 2022."

Answered by AI

Are there many hospitals participating in this research project in our state?

"At the moment, this clinical trial is being conducted at 61 different facilities. Some of the places where this trial is taking place include Garden Grove, Houston and Sherbrooke. If you are interested in participating, try to choose a location near you to reduce travel time and expenses."

Answered by AI

Could patients who are 18 years or older participate in this clinical trial?

"This study's age limit is between 40-65 years old."

Answered by AI

Am I eligible to help with this research?

"Up to 370 individuals aged between 40 and 65 that are experiencing hot flashes may be admitted into this clinical trial. The main criteria that applicants must meet are as follows: they must have undergone at least 12 months of spontaneous amenorrhea before signing the informed consent form, or have had at least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels of over 40 mIU/mL and a serum estradiol concentration of under 30 pg/mL, or have had at least 6 months after a hysterectomy at signing of informed consent with serum FSH levels of over 40 mIU"

Answered by AI

How many people total are allowed to sign up for this research project?

"To begin the trial, 370 patients who meet the eligibility requirements must be enrolled. These patients can come from various locations, such as National Institute of Clinical Research - Garden Grove in Garden Grove, California and UT Health Women's Research Center at Memorial City in Houston, Texas."

Answered by AI

Who else is applying?

What state do they live in?
New York
Other
Alabama
Texas
How old are they?
18 - 65
What site did they apply to?
Womens Health Care Research Corporation
Accel Research Sites - Cahaba Medical Care
Columbia University Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+
2

Why did patients apply to this trial?

I’ve been told I’m not a good candidate for hormone replacement therapy. I had a hysterectomy at age 38 with removal of one ovary. I was put on HRT but had to stop as I am now 73. And I now have hot flashes a few times a day. Zoloft has been tried but is not very effective.
PatientReceived 2+ prior treatments
Tired of my doctors telling me that hot flashes are normal and that we basically have to deal with them! I don’t feel normal being that I don’t have a *** drive at all. Brain fog is terrible! A friend told me about these studies and I suddenly felt some hope in this rollercoaster ride of hot flashes….
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long do screenings visits take? What if any is the monetary compensation and how much do you pay also how long is this study?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Columbia University Medical Center: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)
2021. "A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05099159.
~117 spots leftby Apr 2025
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