Effects of Estrogen on Heart Health in Women With Primary Ovarian Insufficiency
Eligible age
30–40 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT06866119 · last updated 2026-09-08