← 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

Must not have

Males will be excluded (hyperandrogenism is unique to females)

Early morning 17-hydroxyprogesterone > 200 ng/dl measured in the follicular phase, which suggests the possibility of congenital adrenal hyperplasia (if elevated during the luteal phase, the 17-hydroxyprogesterone will be repeated during the follicular phase). NOTE: If a 17-hydroxyprogesterone > 200 ng/dl is confirmed on repeat testing, an ACTH stimulated 17-hydroxyprogesterone < 1000 ng/dl will be required for study participation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change occurring over up to 7 days of estradiol administration

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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 agree to use non-hormonal birth control methods during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a female.

Select...

My hormone levels suggest I might have a specific adrenal gland condition.

Select...

I might have Cushing's syndrome, adrenal insufficiency, or acromegaly based on my symptoms or doctor's exam.

Select...

My BMI is either below 18 or above 40.

Select...

I have diabetes or my blood sugar or A1c levels are high.

Select...

I have a serious heart or lung condition.

Select...

I have been cancer-free for 5 years, except for skin cancer.

Select...

I am unable to understand or sign the consent form.

Select...

My obesity is due to a specific hormonal or genetic condition.

Select...

My kidney function is reduced with a GFR under 60.

Select...

I am 18 years old or older.

Select...

I have had breast, ovarian, or endometrial cancer in the past.

Select...

I have signs of increased male traits like more body hair, deeper voice, or enlarged clitoris.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change occurring over up to 7 days of estradiol administration

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Estradiol-induced change in 24-hour urinary LH excretion

Secondary study objectives

Estradiol-induced change in 24-hour urinary FSH excretion

Side effects data

From 2018 Phase 4 trial • 64 Patients • NCT02255175

18%

Breast Tenderness

15%

Cramps

15%

Itchiness at patch site

12%

Headaches

Nausea

Acne

Lower Back Pain

Hot Flashes

Menstrual Bleeding

Bloating

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Perimenopausal Women, Depressed

Perimenopausal Women, Non-depressed

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 16Eligibility criteria met