All > Pcos > Polycystic Ovarian Syndrome

Estradiol for Polycystic Ovary Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Virginia Clinical Research Unit, Charlottesville, VAPolycystic Ovary SyndromeEstradiol - Drug
Eligibility
18 - 30
Female
What conditions do you have?
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Study Summary

This trial is testing if a hormone can help reduce symptoms in women with polycystic ovary syndrome.

Eligible Conditions
  • Polycystic Ovary Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Change occurring over up to 7 days of estradiol administration

Day 7
Estradiol-induced change in 24-hour urinary FSH excretion
Estradiol-induced change in 24-hour urinary LH excretion

Trial Safety

Safety Progress

1 of 3

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1
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1
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1
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Side Effects for

Perimenopausal Women, Depressed
18%Breast Tenderness
15%Cramps
15%Itchiness at patch site
12%Headaches
9%Nausea
6%Hot Flashes
6%Acne
6%Lower Back Pain
6%Menstrual Bleeding
6%Bloating
3%Dizziness
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT02255175) in the Perimenopausal Women, Depressed ARM group. Side effects include: Breast Tenderness with 18%, Cramps with 15%, Itchiness at patch site with 15%, Headaches with 12%, Nausea with 9%.

Trial Design

1 Treatment Group

Transdermal Estradiol
1 of 1

Experimental Treatment

37 Total Participants · 1 Treatment Group

Primary Treatment: Estradiol · No Placebo Group · Phase < 1

Transdermal Estradiol
Drug
Experimental Group · 1 Intervention: Estradiol · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change occurring over up to 7 days of estradiol administration

Who is running the clinical trial?

University of VirginiaLead Sponsor
693 Previous Clinical Trials
1,464,444 Total Patients Enrolled
26 Trials studying Polycystic Ovary Syndrome
1,167 Patients Enrolled for Polycystic Ovary Syndrome
Christopher McCartney, M.D.Principal InvestigatorUniversity of Virginia

Eligibility Criteria

Age 18 - 30 · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are generally healthy, but being overweight, obese, having PCOS (polycystic ovary syndrome), or treated hypothyroidism is acceptable.
References

Frequently Asked Questions

What criteria must be met to become eligible for participation in this clinical trial?

"This clinical trial seeks 37 young adult women aged 18-30 with sclerocystic ovaries who exhibit a regular menstrual cycle and no signs of hyperandrogenism. Other eligibility criteria include general good health, aside from being overweight or obese, having PCOS, or adequately treated hypothyroidism. Additionally, participants must agree to utilize reliable non-hormonal birth control methods during the study's duration." - Anonymous Online Contributor

Unverified Answer

Are there opportunities for new participants in this clinical trial?

"Affirmative. Clinicaltrials.gov states that the scientific trial, initially posted on November 30th 2017, is still open for enrollment. Specifically, 37 individuals from 1 facility need to be recruited for this research project." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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