RECRUITING

Impact of Estradiol on Endothelial Function in Peri-Menopausal Women

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of Estradiol on Endothelial Function in Peri-Menopausal Women

Quick Facts

Study Start:2020-10-01

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04255160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 58 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Kathy Masso, BS

CONTACT

(302) 831-3493

kcmasso@udel.edu

Megan M Wenner, PhD

CONTACT

(302) 831-7343

mwenner@udel.edu

Study Locations (Sites)

University of Delaware

Newark, Delaware, 19716

United States

Collaborators and Investigators

Sponsor: University of Delaware

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-01

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2020-10-01

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

Perimenopause
Vasodilation
Estrogen

Additional Relevant MeSH Terms

Perimenopause
Vasodilation
Estrogen