Prospective Evaluation of the Effects of Menopausal Hormone Therapy on Breast Imaging Findings and Carotid Intima-Media Thickness in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Breast Density From Baseline to Month 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
2 Control Group
Postmenopausal women who do not receive systemic menopausal hormone therapy as part of their routine clinical management. Participants in this cohort will undergo the same prospective clinical and imaging follow-up assessments during the 12-month study period.
1 Menopausal Hormone Therapy Group
Postmenopausal women who receive systemic menopausal hormone therapy as part of their routine clinical management. Participants in this cohort will undergo prospective clinical, breast imaging, endometrial, cardiometabolic, and carotid intima-media thickness assessments during 12 months of follow-up.
干预措施: Menopausal Hormone Therapy (Drug)
结局指标
主要结局
Change in Breast Density From Baseline to Month 3
时间窗: 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.
次要结局
- Change in Breast Density From Baseline to Month 12(Baseline to Month 12)
- Change in Carotid Intima-Media Thickness(Baseline, Month 3, and Month 12)
研究者
Nefise Nazlı YENIGUL
Associate Professor, Department of Obstetrics and Gynecology
Acibadem Bursa Hospital