MenopauseBREV-MHTNCT07810959
Breast and Vascular Effects of Menopausal Hormone Therapy in Postmenopausal Women
An observational study of Menopause, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Menopausal Hormone Therapy
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nefise Nazlı Yenigül contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acıbadem Bursa Hospital
Bursa
Nefise nazlı Yenigül, 5058254618
Nefise nazlı Yenigül, 5058254618, drnefisenaz@gmail.com
About this study
Official title: Prospective Evaluation of the Effects of Menopausal Hormone Therapy on Breast Imaging Findings and Carotid Intima-Media Thickness in Postmenopausal Women
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.
Read the detailed description
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.
- Conditions
- Menopause
- Being tested
- Menopausal Hormone Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menopausal Hormone TherapyDrug
Systemic menopausal hormone therapy prescribed as part of routine clinical care according to individual clinical indications. Treatment is not assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Month 3
Secondary outcomes (2)
Change in Breast Density From Baseline to Month 12
Measured: Baseline to Month 12
Change in Carotid Intima-Media Thickness
Measured: Baseline, Month 3, and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Jun 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nefise Nazlı YENIGUL, Acibadem Bursa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810959
- Sponsor's protocol ID
- ATADEK-2026/09
- Acronym
- BREV-MHT
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Effects of Menopausal Hormone Therapy on Breast Imaging Findings and Carotid Intima-Media Thickness in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07810959
- Acronym / sponsor ID
- BREV-MHT / ATADEK-2026/09
- Conditions
- Menopause
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Menopausal Hormone Therapy Group | – | Drug: Menopausal Hormone TherapyPostmenopausal 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. |
| 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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menopausal Hormone TherapySystemic menopausal hormone therapy prescribed as part of routine clinical care according to individual clinical indications. Treatment is not assigned by the study protocol. | Drug | 1 Menopausal Hormone Therapy Group |
Primary outcome
Change in Breast Density From Baseline to Month 3
Time frame: 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.
2 secondary outcomes
Change in Breast Density From Baseline to Month 12
Time frame: Baseline to Month 12
Change in Carotid Intima-Media Thickness
Time frame: Baseline, Month 3, and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nefise Nazlı Yenigül contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nefise Nazlı Yenigül (5058254618), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Breast Density From Baseline to Month 3 (time frame: Baseline to Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.