RecruitingEarly Phase 1NCT03401047

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


Sponsor

University of Virginia

Enrollment

37 participants

Start Date

Nov 30, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine if estradiol augmentation of luteinizing hormone (LH) secretion secretion (primary endpoint) and follicle-stimulating hormone (FSH) secretion (secondary endpoint) is reduced in adult women with polycystic ovary syndrome.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying how the hormone estrogen affects the brain's control of reproductive hormones in women with polycystic ovary syndrome (PCOS) — a hormonal condition that can cause irregular periods, excess body hair, and fertility problems — compared to women without the condition, to better understand the hormonal imbalances involved. **You may be eligible if...** - You are a post-pubertal woman aged 18 to 30 years (more than 4 years since your first period) - PCOS group: You have PCOS with signs of excess male hormones (such as unwanted hair growth or elevated testosterone) and irregular periods (fewer than 9 per year), without another identified cause - Control group: You have regular menstrual cycles (every 26 to 35 days) and no signs of excess male hormones **You may NOT be eligible if...** - You are outside the 18 to 30 age range - Your irregular periods or hormonal issues are caused by something other than PCOS - You are taking hormonal medications or have health conditions that could affect hormone levels - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEstradiol

Subjects will receive graded doses of transdermal estradiol patches for up to 7 days. Blood estradiol tests will be performed daily, and the number of estradiol patches used will be adjusted to maintain serum estradiol levels of 250-400 pg/ml. Estradiol is a natural hormone.


Locations(1)

University of Virginia Clinical Research Unit

Charlottesville, Virginia, United States

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NCT03401047


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