NCT07394049

Brief Summary

This prospective registry study investigates the impact of new hormone replacement therapy (HRT) delivery methods, such as creams, gels, and sprays, on cardiovascular risk in postmenopausal women. Menopause-related estrogen deficiency leads to metabolic and vascular changes that increase atherosclerosis and cardiovascular events. This study hypothesizes that new HRT forms may reduce cardiovascular risk in high-risk women."

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,408

participants targeted

Target at P75+ for all trials

Timeline
178mo left

Started Aug 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
14.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2041

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2041

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

14.6 years

First QC Date

February 2, 2026

Last Update Submit

July 30, 2026

Conditions

Cardiovascular DiseasesMenopauseHormone Replacement TherapyHormone Replacement Therapy, Post-Menopausal

Keywords

hormone replacement therapycardiovascular diseasemenopause

Outcome Measures

Primary Outcomes (1)

  • MACCE

    defined as death, cardiovascular death, myocardial infarction, stroke, Transient Ischemic Attack, revascularization

    10 years

Study Arms (2)

Post menopausal women with hormone replacement therapy

Postmenopausal women who have been in menopause and have taken any hormone replacement therapy (HRT).

Post menopausal women without hormone replacement therapy (Control)

Postmenopausal women who have been in menopause and have not taken any hormone replacement therapy (HRT) These participants serve as the control cohort to compare outcomes against those receiving HRT.

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy Population: Peri and postmenopausal women with cardiovascular disease or high risk for CVD with and without hormon replacement therapy
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study Population: Peri and postmenopausal women with cardiovascular disease or high risk for CVD with and without hormon replacement therapy

You may qualify if:

  • female sex
  • Age 45-75 years at enrollment
  • Perimenopausal or postmenopausal status documented according to prespecified clinical criteria
  • Increased cardiovascular risk, defined as SCORE \> 5 % (age 45-69 years) or SCORE2-OP \> 5 % (age \> 70 years), or established disease
  • Established cardiovascular disease includes coronary artery disease, cerebrovascular disease and/or peripheral artery disease, as specified in the approved protocol
  • Ability to understand the study procedures and provide written informed consent

You may not qualify if:

  • Age \<45 years or \> 75 years
  • Active malignancy at screening
  • Inability to provide written informed consent or to comply with study procedures
  • Severe renal impairment, defined as estimated glomerular filtrate rate \<30 ml/min/1.73m2, or dialysis dependance
  • Advanced liver disease, defined as Child-Pugh class C
  • Known genetic cardiomyopathiy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinic for Cardiology, Angiology and Intensive Care at Charité Mitte Berlin

Berlin, Germany

Location

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

prospectively defined blood sampling protocol

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Malte Kelm, MD

    Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

    STUDY DIRECTOR

  • Lisa Dannenberg, MD

    Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Dannenberg, MD

CONTACT

+49 2118105187lisaKristina.Dannenberg@med.uni-duesseldorf.de

Saskia Pietrucha, M.Sc.

CONTACT

+49 2118105187saskia.pietrucha@med.uni-duesseldorf.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 6, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

March 1, 2041

Study Completion (Estimated)

March 1, 2041

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

not necessary

Locations

DE(2)