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An Observational Study to Learn More About Vasomotor Symptoms Burden and Treatment Patterns in Menopausal Women Before and After Participating in OASIS Studies
NCT06949553 · View on ClinicalTrials.gov ↗
Study Summary
This is an observational study to learn more about vasomotor symptoms (VSM) burden and treatment patterns in menopausal women before and after participating in OASIS studies. 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 part
Conditions Studied
Interventions
- OTHER No study intervention
Study Locations (1)
New Jersey
- Bayer US — Whippany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-04-30 |
| Est. Completion | 2029-02-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06949553
The ClinicalTrials.gov registry entry for NCT06949553 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Vasomotor Symptoms (VMS) Associated With Menopause appearing as the primary indexed condition, and to 1 intervention — of which No study intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06949553 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06949553 about?
NCT06949553 is a clinical study titled "An Observational Study to Learn More About Vasomotor Symptoms Burden and Treatment Patterns in Menopausal Women Before and After Participating in OASIS Studies". This is an observational study to learn more about vasomotor symptoms (VSM) burden and treatment patterns in menopausal women before and after participating in OASIS studies. In this study, data from women with VMS associated with menopause who took part in any of the three OASIS studies and were t...
What is the current status of trial NCT06949553?
This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2025-04-30. Estimated completion is 2029-02-15.
What conditions does trial NCT06949553 study?
This clinical trial studies the following conditions: Vasomotor Symptoms (VMS) Associated With Menopause. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06949553?
The interventions under investigation include: No study intervention (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06949553?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06949553 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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