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Elinzanetant for Hot Flashes (OASIS-1 Trial)
OASIS-1 Trial Summary
This trial is studying a better way to treat women who have hot flashes after menopause.
- Hot Flashes
OASIS-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOASIS-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 199 Patients • NCT03596762OASIS-1 Trial Design
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Who is running the clinical trial?
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- You are experiencing moderate to severe menopause-related hot flashes and want treatment for them.You have an untreated thyroid problem, either an overactive thyroid or an underactive thyroid.You have a medical condition that could make it hard to understand hot flashes or other symptoms related to blood vessel function, such as an ongoing infection with high fever, pheochromocytoma, or carcinoid syndrome.If you experience any unexpected vaginal bleeding after menopause.You are experiencing strong and frequent hot flashes due to menopause and are actively looking for treatment.The participant has completed the Hot Flash Daily Diary for at least 11 days during the two weeks preceding the baseline visit, and they have recorded at least 50 moderate or severe hot flashes over the last 7 days that the HFDD was completed.
- Group 1: Elinzanetant (BAY3427080)
- Group 2: Placebo + elinzanetant
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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