An Observational Study to Learn More About Vasomotor Symptoms Burden and Treatment Patterns in Menopausal Women Before and After Participating in OASIS Studies

Part of paid clinical trials in Whippany, New Jersey.

Sponsor
Bayer
Study ID
NCT06949553
Status
Recruiting
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Conditions

  • Vasomotor Symptoms (VMS) Associated With Menopause

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • No study intervention — OTHER
    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.

Study Details

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 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.

Key Dates

Start date
Apr 30, 2025
Status verified
May 2026
Primary completion
May 15, 2028
Completion
Feb 15, 2029

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Group 1
    Patients who had participated in 1 of the 3 OASIS trials

Primary Outcome Measure

Prescription medication(s) used to treat VMS (Vasomotor symptoms) related to menopause [ Time Frame: Survey will remain open from Day 1 up to 12 weeks after Day 1. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bayer USWhippanyNew Jersey07981-

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Bayer US· Whippany, NJ

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