Clinical trial NCT06949553: An Observational Study to Learn More About Vasomotor Symptoms Burden and Treatment Patterns in Menopausal Women Before and After Participating in OASIS Studies
Official title: OASIS PoST-Trial PAtient Registry (OASIS STAR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vasomotor Symptoms (VMS) Associated With Menopause
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2025-04-29
Enrollment: 250
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Prescription medication(s) used to treat VMS (Vasomotor symptoms) related to menopause
timeFrame: Survey will remain open from Day 1 up to 12 weeks after Day 1.
measure: Use of OTC (over the counter) medicines to treat moderate-to-severe VMS related to menopause
timeFrame: Survey will remain open from Day 1 up to 12 weeks after Day 1.
measure: Use of non-pharmaceutical therapies to treat moderate-to-severe VMS related to menopause
timeFrame: Survey will remain open from Day 1 up to 12 weeks after Day 1.
measure: Adherence to prescribed and OTC medication and reasons for non-adherence
timeFrame: Survey will remain open from Day 1 up to 12 weeks after Day 1.
measure: Discontinuation of prescribed and OTC medication and reasons for discontinuation
timeFrame: Survey will remain open from Day 1 up to 12 weeks after Day 1.
measure: Prescription medications used to treat VMS related to menopause
timeFrame: 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.
measure: Adherence to prescribed medication
timeFrame: 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.
measure: Discontinuation of prescribed medication
timeFrame: 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:
measure: Treatment pattern for VMS medications in the 12-month period prior to initiation of the OASIS trial and the month post-OASIS trial period
timeFrame: 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.
measure: Time from OASIS trial completion and 4-week follow-up to start of each VMS treatment
timeFrame: Retrospective analysis after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies
measure: Frequency of outpatient office visits by specialty of healthcare provider (HCP)
timeFrame: Retrospective analysis from 6 months after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies.
measure: The 5 most common reasons for outpatient visits
timeFrame: Retrospective analysis from 6 months after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies.
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Bayer US
state: New Jersey
Study officials:
References: