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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
OASIS-3 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.Check my eligibility
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.See study design
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.
OASIS-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hot flushes
Secondary outcome measures
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.
OASIS-3 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.
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Who is running the clinical trial?
BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,350 Total Patients Enrolled
13 Trials studying Hot Flashes
2,976 Patients Enrolled for Hot Flashes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that may make it hard to understand and interpret symptoms like hot flashes, such as an ongoing infection, pheochromocytoma, or carcinoid syndrome.You have not received treatment for an overactive or underactive thyroid gland.You experience unusual bleeding after menopause and the cause is unknown.You have strong, uncomfortable hot flashes caused by menopause and are actively looking for ways to treat them.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Elinzanetant (BAY3427080)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Hot Flashes Patient Testimony for trial: Trial Name: NCT05030584 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any restrictions on who is able to join this clinical trial?
"The study's organizers are looking for approximately 508 individuals who experience hot flashes and are between 40-65 years old."
Answered by AI
What is the public's opinion of Elinzanetant (BAY3427080)?
"There is some clinical data to support the efficacy of Elinzanetant (BAY3427080), as well as evidence from multiple rounds of testing that confirm its safety. Consequently, our team has rated it a 3 on Power's safety scale."
Answered by AI
Are new participants currently being sought for this trial?
"This particular clinical trial is not looking for participants at this moment, as noted on the most recent update hosted on clinicaltrials.gov (11/16/2022). Although, there are 32 other trials currently enrolling patients."
Answered by AI
Would this experiment include elderly individuals as participants?
"The age limit for this clinical trial is set at 65 years. All patients that are over the age of 40 and younger than the maximum age limit are eligible to participate."
Answered by AI
At how many different facilities is this clinical trial being administered?
"There are 51 clinical trial locations for this study, some of which include Manna Research (Levis) in Levis, Quebec, Manna Research (Nepean) in Nepean, Ontario, and Mesa Obstetricians and Gynecologists, Ltd. in Mesa, Arizona."
Answered by AI
Who else is applying?
What state do they live in?
Quebec
Nevada
Alabama
Other
How old are they?
18 - 65
What site did they apply to?
Paramount Research Solutions-College Park
Las Vegas Clinical Trials, LLC
Clinical Research of Philadelphia, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
I have been suffering from hot flashes. My hot flashes and night sweats are increasing and I am over it.
PatientReceived no prior treatments
I’ve been experiencing these hot flashes for over a year now. I’ve been using dietary restrictions and vitamin and mineral supplements with exercise regime to try and better my situation .
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Is this trial still going on? My doctor told me this drug was just approved?
PatientReceived no prior treatments
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