Premature Ovarian Failure Clinical Trials

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Effects of Estrogen Replacement on Cardiometabolic Endpoints in Women With Primary Ovarian Insufficiency

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 40
Healthy Volunteers: t
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Lauren Maldonado, MD, MPH
LYMALDONADO@MGH.HARVARD.EDU
617-643-4420
Backup
Markella V. Zanni, MD
mzanni@mgh.harvard.edu
617-726-7948
Time Frame
Start Date: 2026-06-22
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 45
Treatments
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.
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov