Menopausal Hormone Therapy: Systemic menopausal hormone therapy prescribed as part of routine clinical care according to individual clinical indications. Treatment is not assigned by the study protocol.
Study summary
This prospective, single-center, observational controlled cohort study aims to evaluate the effects of menopausal hormone therapy (MHT) on breast imaging findings and carotid intima-media thickness in postmenopausal women.
A total of 120 postmenopausal women will be enrolled. Participants will be observed in two groups according to their clinical management: women receiving systemic menopausal hormone therapy (n=70) and women not receiving systemic menopausal hormone therapy (n=50). Breast imaging findings, breast density, menopausal symptoms, endometrial findings, cardiometabolic parameters, and carotid intima-media thickness will be prospectively evaluated during a 12-month follow-up period.
Eligibility
Sex
FEMALE
Min age
45 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
* Women aged 45-60 years
* Postmenopausal status, defined as at least 12 months of amenorrhea since the final menstrual period
* Presentation with menopausal symptoms
* Baseline breast ultrasonography available
* Mammographic imaging performed within the previous 12 months
* Ability to comply with the 12-month follow-up protocol
* Provision of written informed consent
Exclusion Criteria:
* Perimenopausal status
* Use of any menopausal hormone therapy within the previous 6 months
* History of breast cancer or active breast cancer
* Suspicious breast lesion at baseline imaging (BI-RADS category 4 or higher)
* Unexplained uterine bleeding
* Absolute contraindication to menopausal hormone therapy, including active thromboembolic disease, previous myocardial infarction, or active liver disease
Primary outcome measure(s)
Change in Breast Density From Baseline to Month 3 — Baseline to Month 3 Change in breast density from baseline to Month 3 will be evaluated using breast imaging. Breast density will be classified according to the ACR BI-RADS breast composition categories (a: almost entirely fatty, b: scattered areas of fibroglandular density, c: heterogeneously dense, and d: extremely dense). A categorical change will be defined as an increase or decrease of at least one BI-RADS breast density category compared with baseline.
Trial sites (1)
Facility
City
Region
Status
Acıbadem Bursa Hospital
Bursa
Turkey (Türkiye)
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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