Vasomotor Symptoms (VMS) Associated With MenopauseOASIS STARNCT06949553
An Observational Study to Learn More About Vasomotor Symptoms Burden and Treatment Patterns in Menopausal Women Before and After Participating in OASIS Studies
An observational study of Vasomotor Symptoms (VMS) Associated With Menopause, run by Bayer at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms (VMS) Associated With Menopause
- What is being tested?
- No study intervention
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2025to 28 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OASIS PoST-Trial PAtient Registry (OASIS STAR)
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.
Read more
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.
- Being tested
- No study intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study interventionOther
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 group | Role | What they receive |
|---|---|---|
| Group 1 | Patients who had participated in 1 of the 3 OASIS trials Receives: Other: No study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Collected from external linked data source(s)
Measured: 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
Collected from external linked data source(s)
Measured: 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)
Collected from external linked data source(s)
Measured: 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
Collected from external linked data source(s)
Measured: Retrospective analysis from 6 months after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start30 Apr 2025
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor Symptoms (VMS) Associated With MenopauseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949553
- Sponsor's protocol ID
- 22884
- Acronym
- OASIS STAR
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OASIS PoST-Trial PAtient Registry (OASIS STAR)
- ClinicalTrials.gov ID
- NCT06949553
- Acronym / sponsor ID
- OASIS STAR / 22884
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No study interventionPatients who had participated in 1 of the 3 OASIS trials |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No study interventionNo 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. | Other | Group 1 |
Primary outcome
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.
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.
Use of OTC (over the counter) medicines to treat moderate-to-severe VMS related to menopause
Time frame: Survey will remain open from Day 1 up to 12 weeks after Day 1.
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.
Use of non-pharmaceutical therapies to treat moderate-to-severe VMS related to menopause
Time frame: Survey will remain open from Day 1 up to 12 weeks after Day 1.
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.
Adherence to prescribed and OTC medication and reasons for non-adherence
Time frame: Survey will remain open from Day 1 up to 12 weeks after Day 1.
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.
Discontinuation of prescribed and OTC medication and reasons for discontinuation
Time frame: Survey will remain open from Day 1 up to 12 weeks after Day 1.
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.
Prescription medications used to treat VMS related to menopause
Time frame: 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.
Collected from external linked data source(s)
Adherence to prescribed medication
Time frame: 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.
Collected from external linked data source(s)
Discontinuation of prescribed medication
Time frame: 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.
Collected from external linked data source(s)
4 secondary outcomes
Treatment pattern for VMS medications in the 12-month period prior to initiation of the OASIS trial and the month post-OASIS trial period
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Retrospective analysis from 6 months after LPLV (range from 10OCT2023 to 12FEB2024) of one of the three OASIS studies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasomotor Symptoms (VMS) Associated With Menopause, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.