Breast and Vascular Effects of Menopausal Hormone Therapy in Postmenopausal Women

NCT07810959 | Recruiting

• 1 other identifier: ATADEK-2026/09
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

• Change in Breast Density From 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.

  Baseline to Month 3

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Drug: Menopausal Hormone Therapy

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.

Interventions

Menopausal Hormone Therapy DRUG

Systemic menopausal hormone therapy prescribed as part of routine clinical care according to individual clinical indications. Treatment is not assigned by the study protocol.

1 Menopausal Hormone Therapy Group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: Postmenopausal women aged 45 to 60 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women aged 45-60 years, including women receiving systemic menopausal hormone therapy and a control cohort not receiving systemic menopausal hormone therapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead

Study Sites (1)

Acıbadem Bursa Hospital

Bursa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Hormone Replacement Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Nefise Nazlı Yenigül

CONTACT

5058254618

Nefise Nazlı Yenigül

CONTACT

5058254618; drnefisenaz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

TU (1)