Recruiting

Estrogen Replacement Therapy

Sponsor:

Massachusetts General Hospital

Code:

NCT06866119

Conditions

Primary Ovarian Insufficiency

Premature Menopause

Metabolic Complications

Endothelial Function (FMD)

Estrogen Replacement Therapy

Eligibility Criteria

Sex: Female

Age: 30 - 40

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Primary Ovarian Insufficiency

Premature Menopause

Metabolic Complications

Endothelial Function (FMD)

Estrogen Replacement Therapy

Study ID

NCT06866119

Start date

Jun 22, 2026

Status verified date

Jan, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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 and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 8, 2026

Last verified

Jan, 2026

Keywords

  • primary ovarian insufficiency
  • premature menopause
  • estrogen replacement therapy
  • cardiovascular disease prevention
  • POI
  • ERT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-09-08.