Estrogen therapy and heart health in women with POI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows women aged 30-40 who were recently diagnosed with primary ovarian insufficiency and plan to start transdermal estrogen and progesterone therapy. Cardio-metabolic endpoints, including endothelial function and body composition, are measured at baseline and after six months of treatment, with healthy controls matched on age, BMI, and risk. The goal is to see if short-term estrogen replacement improves surrogate markers of cardiovascular health in POI. Findings could strengthen guidance for cardiometabolic preventive care in POI. The study is run at Massachusetts General Hospital with no other sites participating.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Lauren Maldonado, MD, MPH
• Email: LYMALDONADO@MGH.HARVARD.EDU
• Phone: 617-643-4420

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.