A Prospective Multicenter Cohort Study of Contemporary Menopausal Hormone Therapy and Cardiovascular Outcomes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age45-75
SponsorHeinrich-Heine University, Duesseldorf

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

3,408 Participants
are grouped into 2 trial groups