Prospective evaluation of the effects of menopausal hormone therapy on breast imaging findings and carotid Intima-Media thickness in postmenopausal women

NCT ID NCT07810959

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First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

45 to 60 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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How to take part

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Contacts and locations

Locations

  • Acıbadem Bursa Hospital

    RECRUITING

    Bursa, Turkey (Türkiye)

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