Health TrialsbyHealthPanel

Breast and Vascular Effects of Menopausal Hormone Therapy in Postmenopausal Women

ConditionMenopause
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age45-60
SponsorSanliurfa Mehmet Akif Inan Education and Research Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: 1 Menopausal Hormone Therapy Group1 intervention
Group B: 2 Control Group0 interventions

Trial outcomes

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.

Time frame
Baseline to Month 3

Secondary outcomes

1

Change in Breast Density From Baseline to Month 12

Time frame
Baseline to Month 12
2

Change in Carotid Intima-Media Thickness

Time frame
Baseline, Month 3, and Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Lead sponsor

Acibadem Bursa Hospital

Sponsor institution

Source ClinicalTrials.gov
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