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NCT07394049
A Prospective Multicenter Cohort Study of Contemporary Menopausal Hormone Therapy and Cardiovascular Outcomes
Conditions: Hormone Replacement Therapy, Cardiovascular Diseases, Hormone Replacement Therapy, Post-Menopausal, Menopause
Sex: Female
Ages: 45 Years – 75 Years
Healthy volunteers: Yes
Enrollment: 3408
Sponsor: Heinrich-Heine University, Duesseldorf
Location: Clinic for Cardiology, Angiology and Intensive Care at Charité Mitte Berlin Berlin
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."
Eligibility Criteria
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 \ 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 \
Source: ClinicalTrials.gov (NCT07394049). StuddyBuddy aggregates publicly available trial information.