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NCT06949553 · ClinicalTrials.gov registry record
An Observational Study to Learn More About Vasomotor Symptoms Burden and Treatment Patterns in Menopausal Women Before and After Participating in OASIS Studies
A clinical trial of Vasomotor Symptoms (VMS) Associated With Menopause, sponsored by Bayer.
- Recruiting
- Registry status
- 250
- Enrollment target
- 1
- Study location
NCT06949553: Recruiting study of Vasomotor Symptoms (VMS) Associated With Menopause, sponsored by Bayer.
NCT06949553 is a study of Vasomotor Symptoms (VMS) Associated With Menopause that is actively recruiting participants, run by Bayer. The registered enrollment target is 250 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06949553, a study of Vasomotor Symptoms (VMS) Associated With Menopause, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Measured using a one time Web-based survey. Survey collects retrospective information from 12 months before the FPFV (range from 27AUG2021 to 29OCT2021) of one of the three OASIS studies.
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 |
What NCT06949553 shows while recruiting
NCT06949553 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap.
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.
NCT06949553 reports a single indexed study location in New Jersey.
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.
What interventions are being tested in trial NCT06949553?
The interventions under investigation include: No study intervention (OTHER).
Who is sponsoring clinical trial NCT06949553?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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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