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Hormone Therapy

Estradiol for Perimenopause

Phase 4
Recruiting
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Live in Delaware
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to day 7
Awards & highlights

Study Summary

This trial is studying the effect of the hormone estradiol on how well blood vessels work in perimenopausal women.

Who is the study for?
This trial is for peri-menopausal women aged 40-58 living in Delaware, experiencing changes in their menstrual cycles or short-term amenorrhea. It's not open to those with cardiovascular disease, blood clots, stroke, cancer, liver disease, extreme body weights (BMI <18 or >30), tobacco users, pregnant/breastfeeding women, high blood pressure patients not controlled without medication.Check my eligibility
What is being tested?
The study tests the effects of Estradiol patches on vascular endothelial function in peri-menopausal women. Participants will either receive the Estradiol patch or a placebo to compare outcomes and understand how advancing reproductive age affects vascular health.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones associated with hormone treatments like Estradiol may include skin irritation at the patch site, headaches, breast tenderness/pain and nausea.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to day 7 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 (Flow mediated dilation or FMD)
Secondary outcome measures
Endothelial Cell Protein Expression
Endothelin Receptor Responses

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EstradiolExperimental Treatment1 Intervention
Transdermal estradiol (0.1mg/day patch)
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,547 Total Patients Enrolled
University of DelawareLead Sponsor
154 Previous Clinical Trials
25,131 Total Patients Enrolled

Media Library

Estradiol (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04255160 — Phase 4
Perimenopause Research Study Groups: Placebo, Estradiol
Perimenopause Clinical Trial 2023: Estradiol Highlights & Side Effects. Trial Name: NCT04255160 — Phase 4
Estradiol (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04255160 — Phase 4
Perimenopause Patient Testimony for trial: Trial Name: NCT04255160 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what ailment is Estradiol (mylan or vivelle dot patch) primarily applied?

"Estradiol, supplied as Mylan or Vivelle Dot Patch, is routinely used to address issues such as amenorrhea (absence of menstrual period) and hypoestrogenism. It also has applications in treating menopause-related vasomotor symptoms and breast cancer."

Answered by AI

Am I eligible to take part in this scientific experiment?

"This medical experiment currently seeks 80 individuals experiencing perimenopause aged 40-58. To qualify, applicants must exhibit a fluctuation in their cycle of more than 7 days within 10 cycles or be absent from menstruation for two to twelve months."

Answered by AI

Is there an opportunity for individuals to become involved in this clinical trial?

"Data published on clinicaltrials.gov indicates that this medical trial is open for recruitment, having been initially posted in October of 2020 and recently updated in November 2022."

Answered by AI

How many patients are participating in the current experiment?

"Indeed. Clinicaltrials.gov data reveals that the recruitment process for this clinical trial began on October 1st 2020 and was most recently updated November 2nd 2022. The study currently has a goal of gathering 80 patients from one medical centre."

Answered by AI

Is Estradiol (mylan or vivelle dot patch) a secure treatment for individuals?

"Our team at Power has assigned Estradiol (mylan or vivelle dot patch) a rating of 3 on the safety scale, as it is in Phase 4 trials status which indicates its approval."

Answered by AI

Does this trial offer enrollment to octogenarians?

"This medical study is seeking participants aged 40 to 58. Additionally, there are 5 trials for those under 18 years old and 29 for individuals over 65."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Florida
How old are they?
18 - 65
What site did they apply to?
University of Delaware
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have been suffering for quite some time and thought it would be a good trial to enroll in.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Impact of Estradiol on Endothelial Function in Peri-Menopausal Women
Megan M. Wenner 2020. "Impact of Estradiol on Endothelial Function in Peri-Menopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04255160.
All > Perimenopause
~4 spots leftby Jun 2024
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