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Neurokinin Antagonist

Elinzanetant for Menopausal Hot Flashes (OASIS-3 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 56
Awards & highlights
Pivotal Trial

Summary

This trial is to study a possible new treatment, elinzanetant, for hot flashes in women who have been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. The study will compare elinzanetant to a placebo, which is a treatment that looks like the medicine but does not have any medicine in it.

Who is the study for?
This trial is for postmenopausal women experiencing moderate to severe hot flashes, who have not had a menstrual cycle for at least 6-12 months or have undergone surgery related to menopause. They must be seeking treatment and able to record their symptoms in a diary. Women with certain heart conditions, cancer history (except specific skin cancers), uncontrolled hypertension, thyroid disorders without stable treatment, abnormal mammograms or uterine findings are excluded.
What is being tested?
The study tests Elinzanetant's effectiveness and safety against placebo over 52 weeks. Elinzanetant aims to reduce hot flashes by blocking neurokinin signals. Participants will take two capsules daily of either the medication or placebo and track their hot flash experiences electronically while attending regular health checks.
What are the potential side effects?
While the side effects aren't specified here, potential risks may include reactions similar to other hormone therapies such as headaches, nausea, dizziness or more serious conditions like blood clots or liver issues based on exclusion criteria regarding heart and liver health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 56 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 menopause specific quality of life scale (MENQOL) total score over time
Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score over time.

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Elinzanetant (BAY3427080)Active Control1 Intervention
Participants will receive 120 mg elinzanetant orally once daily.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo orally once daily.

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,275 Previous Clinical Trials
25,538,771 Total Patients Enrolled

Media Library

Elinzanetant (Neurokinin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05030584 — Phase 3
Hot Flush Research Study Groups: Placebo, Elinzanetant (BAY3427080)
Hot Flush Clinical Trial 2023: Elinzanetant Highlights & Side Effects. Trial Name: NCT05030584 — Phase 3
Elinzanetant (Neurokinin Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05030584 — Phase 3
Hot Flush Patient Testimony for trial: Trial Name: NCT05030584 — Phase 3
~151 spots leftby Nov 2025
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