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Can estrogen protect hearts in early menopause? new study aims to find out

NCT ID NCT06866119

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 2 times

Summary

This observational study will follow 45 women with primary ovarian insufficiency (POI)—a condition that causes early menopause—who are starting estrogen replacement therapy. Researchers will measure heart health markers before and after 6 months of treatment and compare them to healthy women without POI. The goal is to see if estrogen therapy improves blood vessel function and other metabolic signs related to heart disease.

What this could mean

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

Active substance
estrogen replacement therapy (transdermal 17beta-estradiol and progesterone)
What this could lead to
If successful, this could provide stronger evidence that estrogen therapy helps protect the heart in women with early menopause.
What could go wrong
This is a small observational study (45 participants) that does not test a new treatment—it only measures existing therapy effects. Results may not apply to all women with POI.

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 45 people

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

Started

Jun 2026

Expected to finish

Jun 2029

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

The study population is comprised of women newly diagnosed with POI (within 6 months) who are planning to clinically initiate hormonal replacement with 100mcg transdermal 17beta-estradiol twice weekly and micro-ionized progesterone (either 200mg cyclically or 100mg daily). For comparison, healthy women without POI matched 1:1 on age, BMI, and PREVENT™ risk score category (low-high risk) will also be studied.

Ages

30 to 40 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 (I): * female sex * age 30-40 * CASE PARTICIPANTS ONLY: clinically documented POI diagnosis within 6 months * CASE PARTICIPANTS ONLY: planning to clinically initiate 100mcg transdermal 17beta-estradiol twice weekly and micro-ionized progesterone (either 100mg daily or 200mg cyclically) * CONTROL PARTICIPANTS ONLY: regular menstrual cycles every 21-35 days Exclusion criteria (E): * CASE PARTICIPANTS ONLY: genetic POI etiology * CASE PARTICIPANTS ONLY: any prior initiation of ERT * systemic estrogen, progesterone or testosterone therapy within the past 6 months (including contraception, except for locally acting intrauterine devices - IUDs) * lipid lowering therapy within the past 6 months * use of antihypertensive medication within the past 6 months * current treatment with prescription, systemic (oral, IV, or IM) steroids or anti-inflammatory/immune suppressant medical therapies (excluding topical therapies, UV therapy, ASA-derivative therapies, or NSAIDS) for autoimmune/inflammatory diseases (psoriasis, RA, IBD, lupus), post-transplant care, asthma, or pain syndromes * use of oral steroids or prescription oral anti-inflammatory/immune suppressant medication for \>7 days within the past 1 month * use of IV or IM steroids or IV or IM anti-inflammatory/immune suppressant medication within the past 3 months * self-reported history of breast and/or estrogen dependent malignancy * self-reported history of deep vein thromboembolism, pulmonary embolism or stroke * self-reported severe liver disease such as cirrhosis * self-reported hypercoagulable disorder * uncontrolled hypertension at baseline Visit #1- systolic blood pressure (SBP) ≥180 and/or diastolic blood pressure (DBP) ≥110 * tobacco use within 6 months * self-reported history of myocardial infarction, stroke, coronary revascularization or diabetes as a CVD risk equivalent * stable or unstable angina * self-reported history of heart failure * pregnancy or breastfeeding * concurrent enrollment in conflicting research study

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Conditions

The condition(s) this trial relates to.

premature menopause primary ovarian failure

As listed by the trial registrant

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

Endothelial function (FMD) Estrogen replacement therapy Metabolic complications Premature menopause Primary ovarian insufficiency

How to take part

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

  1. The places running it

    1 site. 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

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

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Other studies related to the condition(s) this trial covers.