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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06866119
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 40 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
45 participants (estimated)

Arms

  • Arm: Case participants with Primary Ovarian Insufficiency
    This group is comprised of women (assigned female at birth), age 30-40yo who have a clinically documented diagnosis of primary ovarian insufficiency (POI) within 6 months and be planning to clinically initiate estrogen replacement therapy (with 100mcg transdermal 17beta-estradiol twice weekly and micro-ionized progesterone either 100mg daily or 200mg cyclically) with their own provider. Women in the group may not be on systemic estrogen, progesterone or testosterone therapy, have contraindications for estrogen administration or known atherosclerotic cardiovascular disease or equivalents. They must also not take lipid lowering therapy or antihypertensive or anti-inflammatory/immune suppressant medications or be pregnant or breastfeeding. After a telephone screen to determine eligibility, the group will engage in two in-person study visits. The first occurs prior to the initiating estrogen replacement therapy and the second after 6 months of treatment.
  • Arm: Health control participants without Primary Ovarian Insufficiency
    This group is compromised of women (assigned female at birth), age 30-40yo who have regular menstrual cycles every 21-35 days. Women in the group may not be on systemic estrogen, progesterone or testosterone therapy, have contraindications for estrogen administration or known atherosclerotic cardiovascular disease or equivalents. They must also not take lipid lowering therapy or antihypertensive or anti-inflammatory/immune suppressant medications or be pregnant or breastfeeding. After a telephone screen to determine eligibility, the group will in a single in-person study visit.

Primary Outcome Measure

Brachial artery Flow Mediated Vasodilation (FMD) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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By research site
Massachusetts General Hospital· Boston, MA

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