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Could new hormone creams protect menopausal Women's hearts?

NCT ID NCT07394049

Knowledge-focused Sponsor: Heinrich-Heine University, Duesseldorf Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This large registry study will follow over 2,700 postmenopausal women aged 45-75 who use newer forms of hormone replacement therapy (creams, gels, sprays). The goal is to see if these modern delivery methods lower the risk of heart attacks, strokes, and other cardiovascular events. Researchers will track health outcomes over time to understand how these hormones affect heart health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hormone replacement therapy (creams, gels, sprays)
What this could lead to
If successful, this study could clarify whether newer HRT delivery methods lower heart disease risk in menopausal women.
What could go wrong
This is an observational registry, not a controlled trial, so it can show links but not prove cause and effect. Results may take years and could be inconclusive.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Participants

About 3,408 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2041

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

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

Ages

45 to 75 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder cerebrovascular disorder coronary artery disorder peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Hormone replacement therapy Hormone replacement therapy, post-menopausal Menopause

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Berlin, Germany

  • University Hospital Duesseldorf

    Düsseldorf, 40225, Germany

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