Effects of Estrogen Replacement on Cardiometabolic Endpoints in Women With Primary Ovarian Insufficiency
Massachusetts General Hospital
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.
Description
Primary Ovarian Insufficiency (POI) is known to adversely affect bone and CV health. Despite the established role for ERT in bone health and the potential cardioprotection suggested by recent studies, few women with POI receive treatment. In this proposed study, we aim to characterize potential salient short-term benefits of ERT on CV surrogates. We hypothesize that among women newly diagnosed with POI, clinical initiation of ERT with transdermal estrogen will improve cardiometabolic risk surrogates, including endothelial function. This study will enhance the body of evidence underpinning guid…
Eligibility
- Age range
- 30–40 years
- Sex
- Female
- Healthy volunteers
- Yes
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 c…
Location
- Massachusetts General HospitalBoston, Massachusetts