Impact of Estradiol on Endothelial Function in Peri-Menopausal Women

NCT04255160 | Active Not Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 1508142R01HL146558
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Estrogen; Perimenopause; Vasodilation

Keywords

Perimenopause; Vasodilation; Estrogen

Outcome Measures

Primary Outcomes (1)

• Vascular Endothelial Function (Flow mediated dilation or FMD)

  The capacity of the large and small blood vessels to dilate.

  Change in FMD from Baseline to Day 7

Secondary Outcomes (2)

• Endothelial Cell Protein Expression

  Change in fluorescent intensity from Baseline to Day 7

• Endothelin Receptor Responses

  Change from Baseline to Day 7

Study Arms (2)

Estradiol

EXPERIMENTAL

Transdermal estradiol (0.1mg/day patch)

Drug: Estradiol (mylan or vivelle dot patch)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Estradiol (mylan or vivelle dot patch) DRUG

Transdermal estradiol (0.1mg/day patch) will be used by women for 7 days. Administration of the patch will follow the package guidelines to change the patch after 3-4 days of use.

Estradiol

Placebo OTHER

A placebo patch that is visually similar to the estradiol patch will be used for the group not receiving estradiol.

Placebo

Eligibility Criteria

• Age: 40 Years - 58 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Delaware: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 5, 2020
• Study Start: October 1, 2020
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)