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

What this trial 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 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.

Conditions in scope

• Vasomotor Symptoms (VMS) Associated With Menopause

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.

Who can join

Women only · Ages 40 Years to 65 Years · Accepts healthy volunteers.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2025-04-30
• Primary completion: 2028-05-15
• Last update posted: 2026-04-17
• First posted: 2025-04-29

Sponsor & contact

Lead sponsor: Bayer (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

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

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.