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

Massachusetts General Hospital · NCT06866119

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 30–40 · Women only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
45
US sites recruiting
1
Study start
June 22, 2026
Record last updated
September 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Lauren Maldonado, MD, MPH · 617-643-4420 · LYMALDONADO@MGH.HARVARD.EDU

Study contacts (from the official record)

  • Lauren Maldonado, MD, MPH · 617-643-4420 · LYMALDONADO@MGH.HARVARD.EDU
  • Markella V. Zanni, MD · 617-726-7948 · mzanni@mgh.harvard.edu
All heart & blood pressure studies in Massachusetts →
Effects of Estrogen on Heart Health in Women With Primary Ovarian… (NCT06866119) | Bored Studies