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Hormone Therapy

Estradiol for Cardiovascular Risk

N/A
Waitlist Available
Led By Megan Wenner, PhD
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Young women between 18-35 years of age with regular menstrual cycles
Postmenopausal women between 50-65 years of age and no more than 10 years past menopause
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing whether estradiol has an independent effect on how endothelin-1 affects vasomotor function in women.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vascular endothelial function
Secondary outcome measures
Endothelin receptor expression

Side effects data

From 2018 Phase 4 trial • 64 Patients • NCT02255175
13%
Itchiness at patch site
13%
Headaches
10%
Cramps
10%
Breast Tenderness
6%
Bloating
6%
Nausea
6%
Menstrual Bleeding
6%
Waking during the night
6%
Dizziness
3%
Hot Flashes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perimenopausal Women, Non-depressed
Perimenopausal Women, Depressed

Trial Design

2Treatment groups
Experimental Treatment
Group I: No to Low Endogenous EstrogenExperimental Treatment1 Intervention
PMW and young women (YW) will receive medical study clearance after a detailed physical examination. YW will self-administer subcutaneous injections of the gonadotropin-releasing hormone (GnRH) antagonist, ganirelix acetate (Antagon, 0.25 mg/day in 0.5 ml of normal saline, Organon, Inc., West Orange, New Jersey,) daily to suppress endogenous ovarian hormone production (16, 17, 18). This will begin following a separate medical screening at Reproductive Associates of Delaware 48 hours prior to initiating the hormone intervention to rule out other contraindications prior to beginning the treatment. YW will begin using the antagonist on days 26-28 of their menstrual cycle, and continue daily for 10-12 days. The experimental protocol will be conducted in YW after 3-4 days of using the GnRH antagonist. PMW will complete the experimental protocol prior to use of the 17β-estradiol (E2, 0.1 mg/day patch, Vivelle dot; estradiol patch).
Group II: Estrogen Add-BackExperimental Treatment2 Interventions
Estradiol (E2, 0.1 mg/day patch, Vivelle dot; estradiol patch) will be administered for 7 days to both young and PMW. Young women will use the E2 over the last 7 days of Antagon administration.

Find a Location

Who is running the clinical trial?

University of DelawareLead Sponsor
154 Previous Clinical Trials
25,180 Total Patients Enrolled
7 Trials studying Cardiovascular Risk
350 Patients Enrolled for Cardiovascular Risk
American Heart AssociationOTHER
320 Previous Clinical Trials
4,932,440 Total Patients Enrolled
7 Trials studying Cardiovascular Risk
1,113 Patients Enrolled for Cardiovascular Risk
Megan Wenner, PhDPrincipal InvestigatorUniversity of Delaware

Frequently Asked Questions

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Recent research and studies
~6 spots leftby Mar 2025