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RecruitingPolycystic Ovary Syndrome

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

Eligible age

18–30 yrs

Accepts

Women

Locations

1 state

Healthy volunteers

Yes

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About this study

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.

Sponsor: University of Virginia

You may qualify if…

  • ✓ 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

You may not qualify if…

  • ✕ 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)

Where it's recruiting

Virginia

Charlottesville

Source: ClinicalTrials.gov · NCT03401047 · last updated 2025-08-05