Impact of Estradiol on Endothelial Function in Peri-Menopausal Women

• Status: Recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to identify the impact of estradiol (E2) on the mechanisms that regulate vascular endothelial function in peri-menopausal (PERI) women. This study is the first step in understanding factors contributing to endothelial dysfunction in women with advancing reproductive age and in response to E2 administration.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Delaware
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate

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 30kg/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.