Actively Recruiting

Early Phase 1
Age: 18Years - 30Years
FEMALE
Healthy Volunteers
NCT03401047

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

Led by University of Virginia · Updated on 2025-08-05

37

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 30Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 30 years, more than 4 years post-menarche
  • For PCOS group: diagnosis of PCOS with signs of high male hormone levels and irregular periods (fewer than 9 per year), without other causes
  • For control group: regular menstrual cycles every 26-35 days with no signs of high male hormone levels
  • General good health except for overweight, obesity, PCOS, or well-treated hypothyroidism
  • Able and willing to give informed consent
  • Willing to avoid pregnancy using reliable non-hormonal methods during the study
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent
  • Male gender
  • Younger than 18 or older than 30 years
  • Obesity caused by known endocrine or genetic conditions
  • Positive pregnancy test or currently breastfeeding
  • Conditions causing high male hormones or lack of ovulation other than PCOS
  • Signs of virilization (rapid hair growth, voice changes, clitoral enlargement)
  • Very high testosterone levels suggesting tumors
  • DHEA-S levels above normal limits (except mild elevations allowed in PCOS)
  • Elevated early morning 17-hydroxyprogesterone suggesting congenital adrenal hyperplasia without confirmation
  • Abnormal thyroid function unless well-treated hypothyroidism
  • High prolactin levels (except mild elevations in PCOS)
  • Signs of Cushing's syndrome, adrenal insufficiency, or acromegaly
  • Signs of estrogen deficiency or hypothalamic amenorrhea
  • Low blood counts (hematocrit, hemoglobin, platelets, white cells)
  • Diabetes or high blood sugar levels
  • Persistent liver abnormalities except mild elevations in known conditions
  • Serious heart or lung problems
  • Reduced kidney function
  • History of breast, ovarian, or endometrial cancer
  • Other cancers unless disease-free for 5 years
  • Allergy to estradiol patches
  • BMI under 18 or over 40 kg/m2
  • Menstrual cycles shorter than 26 days or follicular phase under 12 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Virginia Clinical Research Unit

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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Research Team

M

Melissa G Gilrain, B.S.

CONTACT

C

Christine Burt Solorzano, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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