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Study on Estradiol and Hormone Secretion in Polycystic Ovary Syndrome

This study is looking into whether women with Polycystic Ovary Syndrome (PCOS) have a different response to the hormone estradiol compared to women without PCOS. Researchers want to see if giving estradiol (a natural hormone) affects the secretion of other hormones, specifically luteinizing hormone (LH) and follicle-stimulating hormone (FSH). You might be able to join if you are a woman between 18 and 30 years old with PCOS, which means you have irregular periods and/or high male hormone levels. The study will measure changes in LH levels in your urine over up to 7 days of estradiol treatment. The current recruitment status is unclear, and the study plans to enroll 37 participants.

Study design
This is a controlled study comparing women with PCOS to healthy women who are matched for body mass index (BMI). It is an interventional study, meaning participants will receive a treatment.
What's involved
You will receive transdermal estradiol patches for up to 7 days, with daily blood tests and urine collection. You will also have a transvaginal ovarian ultrasound on study day 6.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes over up to 7 days of estradiol administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03401047

Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome

Recruiting
EARLY_PHASE1Ages 18–30InterventionalBasic science
University of Virginia
~37 participants
Updated 2025-08-05 on ClinicalTrials.gov
What's tested:Estradiol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Estradiol-induced change in 24-hour urinary LH excretion
Measured over Change occurring over up to 7 days of estradiol administration

Conditions

Polycystic Ovary Syndrome

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NCT03401047

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Virginia Clinical Research Unit

    Charlottesville, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Christine Burt Solorzano, M.D. · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Melissa G Gilrain, B.S.
[email protected]
434-243-6911
Email the study team

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Eligibility criteria

Inclusion

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
Control group: post-pubertal (\> 4 years post-menarche) adult woman aged 18-30 years with regular menstrual periods (every 26-35 days) and no evidence of hyperandrogenism (i.e., no hirsutism, normal serum \[calculated\] free testosterone concentration)
General good health (excepting overweight, obesity, PCOS, and adequately-treated hypothyroidism)
Capable of and willing to provide informed consent
Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period

Exclusion

Inability/incapacity to provide informed consent
Males will be excluded (hyperandrogenism is unique to females)
Age \< 18 years (we do not propose to study children because we have no preliminary data that would support this particular study in children)
Age \> 30 years (since ovarian reserve may decrease beyond age 30)
Obesity resulting from a well-defined endocrinopathy or genetic syndrome
Positive pregnancy test or current lactation
Evidence for non-physiologic or non-PCOS causes of hyperandrogenism and/or anovulation
Evidence of virilization (e.g., rapidly progressive hirsutism, deepening of the voice, clitoromegaly)
Total testosterone \> 150 ng/dl, which suggests the possibility of virilizing ovarian or adrenal tumor
DHEA-S greater than upper reference range limit for controls; and DHEA-S elevation \> 1.5 times the upper reference range limit for PCOS. Mild elevations may be seen in PCOS, and will be accepted in this group.
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.
Abnormal thyroid stimulating hormone (TSH): Note that subjects with stable and adequately treated primary hypothyroidism, reflected by normal TSH values, will not be excluded.
Hyperprolactinemia: Any degree of hyperprolactinemia (confirmed on repeat) will be grounds for exclusion for subjects without PCOS. Hyperprolactinemia \> 20% higher than the upper limit of normal will be grounds for exclusion for subjects without PCOS. Mild prolactin elevations may be seen in PCOS, and elevations within 20% higher than the upper limit of normal will be accepted in this group.
History and/or physical exam findings suggestive of Cushing's syndrome, adrenal insufficiency, or acromegaly
History and/or physical exam findings suggestive of hypogonadotropic hypogonadism (e.g., symptoms of estrogen deficiency) including functional hypothalamic amenorrhea (which may be suggested by a constellation of symptoms including restrictive eating patterns, excessive exercise, psychological stress, etc.)
Persistent hematocrit \< 36% and hemoglobin \< 12 g/dl
Severe thrombocytopenia (platelets \< 50,000 cells/microliter) or leukopenia (total white blood count \< 4,000 cells/microliter)
Previous diagnosis of diabetes, fasting glucose \> or = 126 mg/dl, or a hemoglobin A1c \> or = 6.5%
Persistent liver panel abnormalities, with two exceptions. Mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Also, mild transaminase elevations may be seen in obesity/PCOS; therefore, elevations \< 1.5 times the upper limit of normal will be accepted in these groups.
Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure, asthma requiring intermittent systemic corticosteroids, etc.)
Decreased renal function evidenced by GFR \< 60 ml/min/1.73m2
A personal history of breast, ovarian, or endometrial cancer
History of any other cancer diagnosis and/or treatment (with the exception of basal cell or squamous cell skin carcinoma) unless they have remained clinically disease free (based on appropriate surveillance) for five years
History of allergy to transdermal estradiol patches
BMI \< 18 or \> 40 kg/m2; BMI \< 18 kg/m2 is considered to be underweight, while \> 40 kg/m2 is considered to be class 3 obesity -- both may have marked confounding effects for the outcomes of interest
Menstrual cycles lasting fewer than 26 days: Cycle frequency \< 26 days suggest the possibility of relatively short follicular phases (e.g., \< 12 days). If a subject with a follicular phase shorter than 12 days participates in Aim 1c, they could experience an endogenous gonadotropin surge under surveillance. Since we wish to capture only experimentally-induced surges, we will exclude such subjects.

What this trial measures

  • Estradiol-induced change in 24-hour urinary LH excretionChange occurring over up to 7 days of estradiol administration

    The estradiol-induced change in 24-hour urinary LH excretion is defined as the 24-hour urinary LH excretion immediately prior to estradiol administration vs. the peak 24-hour urinary LH excretion during estradiol administration.