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NCT06866119

Effects of Estrogen on Heart Health in Women With Primary Ovarian Insufficiency

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

The goal of this observational study is to study the effects of treating women with Primary Ovarian Insufficiency (POI) with estrogen replacement therapy to bolster the evidence backing cardiometabolic preventive care in women with POI. The main question it aims to answer is: Does 6 months of estrogen replacement therapy for women with POI improved markers of heart health? Women newly diagnosed with POI (within 6 months) who are planning to start estrogen replacement therapy from their clinical provider will undergo assessment of markers of heart health before and after 6 months of treatment. These markers will also be compared to those obtained from healthy women without POI.

Official title: Effects of Estrogen Replacement on Cardiometabolic Endpoints in Women With Primary Ovarian Insufficiency

Key Details

Gender

FEMALE

Age Range

30 Years - 40 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-03-01

Completion Date

2026-06

Last Updated

2026-01-07

Healthy Volunteers

Yes

Conditions

Primary Ovarian Insufficiency Premature Menopause Metabolic Complications Endothelial Function (FMD)Estrogen Replacement Therapy

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States