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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age30-40
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

45 Participants
are grouped into 2 trial groups

Sponsors and collaborators