Breast and Vascular Effects of Menopausal Hormone Therapy in Postmenopausal Women

Menopausal hormone therapy (MHT) is considered the most effective treatment for menopausal symptoms, particularly vasomotor symptoms. However, its effects on breast tissue and the cardiovascular system may vary according to treatment type, dose, duration, timing of initiation, and individual patient characteristics.

This prospective, single-center, observational controlled cohort study will evaluate postmenopausal women who are managed according to routine clinical practice. A total of 120 women aged 45-60 years will be included. Participants will be classified into two groups according to their clinical treatment: women receiving systemic menopausal hormone therapy (MHT group, n=70) and women not receiving systemic menopausal hormone therapy (control group, n=50).

Participants will be followed for 12 months. Clinical assessments will be performed at baseline and at 3, 6, and 12 months. Breast ultrasonography will be evaluated at baseline, 3 months, and 12 months. Digital breast tomosynthesis will be evaluated at baseline and 12 months. Breast density will be classified according to the American College of Radiology Breast Imaging Reporting and Data System (ACR BI-RADS).

Carotid intima-media thickness will be assessed at baseline, 3 months, and 12 months in eligible participants. Menopausal symptoms, endometrial findings, bleeding patterns, and cardiometabolic parameters will also be prospectively monitored.

The primary objective is to assess the change in breast density during follow-up. Secondary objectives include evaluating breast density at 12 months, new breast imaging findings, menopausal symptom control, bleeding patterns, endometrial changes, cardiometabolic parameters, and changes in carotid intima-media thickness.

The study aims to provide prospective data that may contribute to a more individualized approach to breast and cardiovascular monitoring in postmenopausal women receiving menopausal hormone therapy.

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