An Observational Study to Learn More About Vasomotor Symptoms Burden and Treatment Patterns in Menopausal Women Before and After Participating in OASIS Studies
NCT ID: NCT06949553
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
250 participants
OBSERVATIONAL
2025-04-30
2029-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In this study, data from women with VMS associated with menopause who took part in any of the three OASIS studies and were treated with elizanetant or a placebo, are collected and studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
VMS associated with menopause is a condition in which women who have been through the menopause have hot flashes caused by hormonal changes. Menopause is the stage when a woman stops having menstrual cycles or periods.
No investigational products will be administered in this study. The participants in this study already received the standard of care (SOC) treatment for VMS before and after their participation in the study, as part of their regular care from their doctors. The SOC is the treatment that medical experts consider most appropriate currently.
OASIS is a set of clinical studies. In this study data will be collected from participants who took part in OASIS 1, 2 or 3 . These three studies assessed the safety and effects of elizanetant compared to a placebo for VMS associated with the menopause. Based on the results of these three studies, Bayer filed a New Drug Application for elizanetant.
To better understand the impact of elizanetant on VMS, more knowledge is needed about treatment patterns that were followed for VMS before and after the OASIS studies.
The main purpose of this study is to gather real-world data on participants' prescription trends, whether they continued or stopped taking treatments, and healthcare resource utilization, before and after their participation.
This study will include participants from OASIS 1,2 or 3 from the United States of America, who have agreed to be contacted to share information regarding their treatment. This study will have 2 parts:
Part A - researchers will invite participants to complete an online survey about the treatments given in the year before starting the OASIS study.
Part B - researchers will use tokens (an anonymized number to ensure participants' privacy) to learn about the treatments given to them 6 months after the completion of the OASIS study through their anonymized medical records.
Researchers will collect the following information:
Part A:
* the prescription and over-the-counter medicines used by the participants for VMS in the year before the OASIS start
* whether they continued or stopped taking them, and
* the reason for doing so
Part B:
* the prescription medicines used by the participants for VMS in 6 months after the OASIS ended
* whether they continued or stopped taking them
For Part A the data will be collected from the participant survey between March 2025 and June 2025, and for Part B the data will be collected using participants' medical records between April 2025 to May 2025.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Patients who had participated in 1 of the 3 OASIS trials
No study intervention
No visits or examinations, laboratory tests or procedures are mandated or required for this study. Patients will be recruited through a registry if patients who had participated in previous OASIS trials. After this referral, the study is conducted entirely electronically.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No study intervention
No visits or examinations, laboratory tests or procedures are mandated or required for this study. Patients will be recruited through a registry if patients who had participated in previous OASIS trials. After this referral, the study is conducted entirely electronically.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who confirmed interest in being contacted for further study communication
* Patients who consent to be included in the registry, complete the pre-OASIS trial survey, and agree to be tokenized so that their anonymized real-world data can be accessed
Exclusion Criteria
40 Years
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bayer US
Whippany, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for access to information about Bayer's transparency standards and Bayer studies.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22884
Identifier Type: -
Identifier Source: org_study_id