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

NCT06949553 | Recruiting FDA Drug

• 1 other identifier: 22884
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Vasomotor Symptoms (VMS) Associated With Menopause

Outcome Measures

Primary Outcomes (8)

• Prescription medication(s) used to treat VMS (Vasomotor symptoms) related to menopause

  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.

  Survey will remain open from Day 1 up to 12 weeks after Day 1.

• Use of OTC (over the counter) medicines to treat moderate-to-severe VMS related to menopause

  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.

  Survey will remain open from Day 1 up to 12 weeks after Day 1.

• Use of non-pharmaceutical therapies to treat moderate-to-severe VMS related to menopause

  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.

  Survey will remain open from Day 1 up to 12 weeks after Day 1.

• Adherence to prescribed and OTC medication and reasons for non-adherence

  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.

  Survey will remain open from Day 1 up to 12 weeks after Day 1.

• Discontinuation of prescribed and OTC medication and reasons for discontinuation

  Measured using a one time Web-based survey. Survey collects retrospective information from 12 months before the FPFV (27AUG2021-29OCT2021) of one of the three OASIS studies.

  Survey will remain open from Day 1 up to 12 weeks after Day 1.

• Prescription medications used to treat VMS related to menopause

  Collected from external linked data source(s)

  Retrospective analysis from12 months before the FPFV (range from 27AUG2021 to 29OCT2021) and 6 months after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies.

• Adherence to prescribed medication

  Collected from external linked data source(s)

  Retrospective analysis from12 months before the FPFV (range from 27AUG2021 to 29OCT2021) and 6 months after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies.

• Discontinuation of prescribed medication

  Collected from external linked data source(s)

  Retrospective analysis from12 months before the FPFV (range from 27AUG2021 to 29OCT2021) and 6 months after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies.

Secondary Outcomes (4)

• Treatment pattern for VMS medications in the 12-month period prior to initiation of the OASIS trial and the month post-OASIS trial period

  Retrospective analysis from12 months before the FPFV (range from 27AUG2021 to 29OCT2021) and 6 months after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies.

• Time from OASIS trial completion and 4-week follow-up to start of each VMS treatment

  Retrospective analysis after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies

• Frequency of outpatient office visits by specialty of healthcare provider (HCP)

  Retrospective analysis from 6 months after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies.

• The 5 most common reasons for outpatient visits

  Retrospective analysis from 6 months after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies.

Study Arms (1)

Group 1

Patients who had participated in 1 of the 3 OASIS trials

Other: No study intervention

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.

Group 1

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Women experiencing menopause assigned female at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females from 40 to 65 years, naturally or surgically postmenopausal, who had experienced 50 or more moderate to severe VMS over 7 days during screening

You may qualify if:

• Patients in the US who participated in one of the three OASIS trials for patients with moderate-to-severe VMS related to menopause.
• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer US

Whippany, New Jersey, 07981, United States

RECRUITING

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): February 15, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)