← Back to Search

Hormone Therapy

Estradiol for Polycystic Ovary Syndrome (CRM009 Trial)

Phase < 1
Recruiting
Led By Christopher McCartney, M.D.
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capable of and willing to provide informed consent
PCOS group: post-pubertal (> 4 years post-menarche) adult woman aged 18-30 years with PCOS, defined as clinical and/or laboratory evidence of hyperandrogenism (hirsutism and/or elevated serum [calculated] free testosterone concentration) plus ovulatory dysfunction (irregular menses, fewer than 9 per year), but without evidence for other potential causes of hyperandrogenism and/or ovulatory dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change occurring over up to 7 days of estradiol administration
Awards & highlights

CRM009 Trial Summary

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

Who is the study for?
This trial is for adult women aged 18-30 with Polycystic Ovary Syndrome (PCOS), characterized by excess male hormones and irregular periods, but no other health issues. Participants must avoid pregnancy and have regular menstrual cycles if they're in the control group without PCOS signs.Check my eligibility
What is being tested?
The study tests whether estradiol, a form of estrogen, affects the secretion of hormones involved in ovulation differently in women with PCOS compared to healthy controls. It measures luteinizing hormone as its main focus and follicle-stimulating hormone secondarily.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include skin irritation from patches, changes in mood or libido, headache, nausea, breast tenderness or swelling due to hormonal nature of estradiol.

CRM009 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am able and willing to agree to the study's procedures and risks.
Select...
I am a woman aged 18-30 with PCOS, showing signs of high male hormones and irregular periods.
Select...
I am a woman aged 18-30, have regular periods, and show no signs of excessive male hormones.
Select...
I agree to use non-hormonal birth control methods during the study.

CRM009 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change occurring over up to 7 days of estradiol administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and change occurring over up to 7 days of estradiol administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estradiol-induced change in 24-hour urinary LH excretion
Secondary outcome measures
Estradiol-induced change in 24-hour urinary FSH excretion

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

CRM009 Trial Design

1Treatment groups
Experimental Treatment
Group I: Transdermal EstradiolExperimental Treatment1 Intervention
Subjects will undergo estradiol administration for up to 9 days. Transdermal estradiol patches will be applied each day by study staff during study days two through nine (patches deliver 0.1 mg/day for a total dose of up to 0.6 mg/day).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol
2008
Completed Phase 4
~3960

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,003 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

Media Library

Estradiol (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03401047 — Phase < 1
Polycystic Ovary Syndrome Research Study Groups: Transdermal Estradiol
Polycystic Ovary Syndrome Clinical Trial 2023: Estradiol Highlights & Side Effects. Trial Name: NCT03401047 — Phase < 1
Estradiol (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03401047 — Phase < 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI
~5 spots leftby Apr 2025