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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how estrogen replacement therapy affects heart health in women who have been diagnosed with Primary Ovarian Insufficiency (POI). POI is a condition where the ovaries stop working properly at a younger age than usual, which can lead to early menopause and various health issues. The main goal of the study is to find out if six months of estrogen treatment can improve heart health markers in these women. To participate, women need to be aged 30 to 40, have been diagnosed with POI within the last six months, and be planning to start estrogen therapy.

Participants will have their heart health checked before starting the treatment and again after six months, and their results will be compared to those of healthy women without POI. It’s important to note that certain health conditions and treatments may exclude women from participating, such as a history of certain cancers or heart problems, recent use of hormones, or specific medications. This study is not yet recruiting participants but aims to provide valuable insights into how estrogen can help protect heart health in women with POI.

Gender

FEMALE

Eligibility criteria

• 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