Effects of Estradiol on Blood Vessel Function in Peri-Menopausal Women
Impact of Estradiol on Endothelial Function in Peri-Menopausal Women
This study is testing whether giving estradiol to peri-menopausal women can improve blood vessel function and help reduce their risk of heart problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 58 Years |
| Sex | Female |
| Sponsor | University of Delaware Academic / other |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT04255160 on ClinicalTrials.gov |
What this trial studies
This study investigates how estradiol (E2) affects the mechanisms regulating vascular endothelial function in peri-menopausal women. It aims to understand the factors contributing to endothelial dysfunction during this critical transition period, which may lead to increased cardiovascular disease risk. The study will involve administering estradiol or a placebo to participants and assessing changes in endothelial function. By focusing on women aged 40-58, the research seeks to identify early interventions that could mitigate cardiovascular risks associated with menopause.
Who should consider this trial
Good fit: Ideal candidates are peri-menopausal women aged 40-58 with irregular menstrual cycles.
Not a fit: Patients with a history of cardiovascular disease, certain chronic conditions, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health strategies for peri-menopausal women.
How similar studies have performed: While there is limited research specifically targeting peri-menopausal women, studies on estrogen's effects on cardiovascular health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Peri-menopausal women between 40-58 years of age with variable cycles as defined by increase in cycle length of greater than 7 days within ten consecutive cycles, or amenorrhea for more than 2 months, but less than 12 months. Exclusion Criteria: * Women who are pregnant, planning on becoming pregnant, or are breast feeding; * Women who have a history of cardiovascular disease, blood clots (e.g, pulmonary embolism or deep vein thrombosis), stroke, cancer, or liver disease; * Women who have a body mass index less than 18 or greater than 35kg/m2; * Women who use tobacco products; * Women who's blood pressure is greater than 140/90 mmHg, have been diagnosed by a physician with hypertension or are taking medication for high blood pressure; * Women who have a neurological disease, or diabetes; * Women who have had a hysterectomy or have used hormones (birth control or hormone replacement) within the past 3 months; * Women who have a latex allergy.
Where this trial is running
Newark, Delaware
- University of Delaware — Newark, Delaware, United States (Recruiting)
Study contacts
- Study coordinator: Kathy Masso, BS
- Email: kcmasso@udel.edu
- Phone: (302) 831-3493
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.