Impact of New Hormone Replacement Therapy After Menopause on Heart Health in Women
- Sponsor
- Heinrich-Heine University, Duesseldorf
- Study ID
- NCT07394049
- Status
- Not Yet Recruiting
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Conditions
- Cardiovascular Diseases
- Hormone Replacement Therapy
- Hormone Replacement Therapy, Post-Menopausal
- Menopause
Eligibility Criteria
- Sex
- FEMALE
- Age
- 45 Years - 75 Years
- Healthy Volunteers
- Accepted
Study Details
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."
Key Dates
- First listed
- Feb 6, 2026
- Start date
- Mar 1, 2026
- Status verified
- Feb 2026
- Primary completion
- Mar 31, 2035
- Completion
- Mar 31, 2035
Study Design
- Enrollment
- 2,725 participants (estimated)
Arms
- Arm: Post menopausal women with hormone replacement therapyPostmenopausal women who have been in menopause and have taken any hormone replacement therapy (HRT).
- Arm: Post menopausal women without hormone replacement therapy (Control)Postmenopausal women who have been in menopause and have not taken any hormone replacement therapy (HRT) These participants serve as the control cohort to compare outcomes against those receiving HRT.
Primary Outcome Measure
MACCE [ Time Frame: 10 years ]
Central Contacts
- Lisa Dannenberg, MD+49 2118105187
- Saskia Pietrucha, M.Sc.+49 2118105187
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