💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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