A Prospective Multicenter Cohort Study of Contemporary Menopausal Hormone Therapy and Cardiovascu… (NCT07394049) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Prospective Multicenter Cohort Study of Contemporary Menopausal Hormone Therapy and Cardiovascular Outcomes
Germany3,408 participantsStarted 2026-08-01
Plain-language summary
This prospective registry study investigates the impact of new hormone replacement therapy (HRT) delivery methods, such as creams, gels, and sprays, on cardiovascular risk in postmenopausal women. Menopause-related estrogen deficiency leads to metabolic and vascular changes that increase atherosclerosis and cardiovascular events. This study hypothesizes that new HRT forms may reduce cardiovascular risk in high-risk women."
Who can participate
Age range
45 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* female sex
* Age 45-75 years at enrollment
* Perimenopausal or postmenopausal status documented according to prespecified clinical criteria
* Increased cardiovascular risk, defined as SCORE \> 5 % (age 45-69 years) or SCORE2-OP \> 5 % (age \> 70 years), or established disease
* Established cardiovascular disease includes coronary artery disease, cerebrovascular disease and/or peripheral artery disease, as specified in the approved protocol
* Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
* Age \<45 years or \> 75 years
* Active malignancy at screening
* Inability to provide written informed consent or to comply with study procedures
* Severe renal impairment, defined as estimated glomerular filtrate rate \<30 ml/min/1.73m2, or dialysis dependance
* Advanced liver disease, defined as Child-Pugh class C
* Known genetic cardiomyopathiy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.