Tracking hot flashes and treatment patterns in menopausal women who took part in OASIS studies
OASIS PoST-Trial PAtient Registry (OASIS STAR)
This registry collects health and treatment information from menopausal women who joined the OASIS studies to see how their hot flashes and care changed before and after participation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Whippany, New Jersey) |
| Trial ID | NCT06949553 on ClinicalTrials.gov |
What this trial studies
This is an observational registry of U.S. women who participated in any of the three OASIS trials for moderate-to-severe vasomotor symptoms (VMS) and who were treated with elizanetant or placebo during those trials. No investigational products are given in this follow-up; data are collected via a pre-OASIS survey and by accessing anonymized real-world health records after participants agree to tokenization. The study records symptom burden and treatment patterns before and after OASIS participation without altering participants' clinical care. All participation is voluntary and based on consent to include registry data.
Who should consider this trial
Good fit: Women in the United States who participated in any of the three OASIS trials for moderate-to-severe menopausal VMS and who consent to registry participation and tokenized data access are eligible.
Not a fit: Women who did not participate in an OASIS trial or who decline consent/tokenization will not be included and therefore will not directly benefit from this registry's data.
Why it matters
Potential benefit: If successful, the registry could help doctors and patients better understand real-world symptom burden and treatment patterns after participation in OASIS trials.
How similar studies have performed: Observational registries of menopausal VMS and real-world treatment patterns have informed care previously, but applying this approach specifically to OASIS participants treated with elizanetant is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Whippany, New Jersey
- Bayer US — Whippany, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.