What this trial studies
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 in scope
- Perimenopause
- Vasodilation
- Estrogen
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.
- Placebo (Other) — A placebo patch that is visually similar to the estradiol patch will be used for the group not receiving estradiol.
Who can join
Women only · Ages 40 Years to 58 Years · Accepts healthy volunteers.
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.
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Newark | Delaware | University of Delaware | Unknown |
Status & timeline
- Overall status: Active, not recruiting
- Study type: Interventional
- Phase: PHASE4
- Start date: 2020-10-01
- Primary completion: 2026-09-01
- Last update posted: 2026-04-29
- First posted: 2020-02-05
Sponsor & contact
Lead sponsor: University of Delaware (Other)
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Vascular Endothelial Function (Flow mediated dilation or FMD) (Change in FMD from Baseline to Day 7)
The capacity of the large and small blood vessels to dilate.
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT04255160 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.