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RecruitingHyperandrogenismPolycystic Ovary SyndromePuberty

Hyperandrogenemia and Altered Day-night LH Pulse Patterns

Eligible age

10–17 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, in mid- to late pubertal girls with hyperandrogenism, androgen-receptor blockade (spironolactone) improves the ability of progesterone to acutely reduce waking luteinizing hormone pulse frequency (primary endpoint).

Sponsor: University of Virginia

You may qualify if…

  • ✓ Mid- to late pubertal adolescent girl (at least Tanner breast stage 3, but no more than 2 years postmenarcheal)
  • ✓ Hyperandrogenism, defined as a serum (calculated) free testosterone concentration greater than the Tanner stage-specific reference range and/or unequivocal evidence for hirsutism
  • ✓ General good health (excepting overweight, obesity, hyperandrogenism, and adequately-treated hypothyroidism)
  • ✓ Capable of and willing to provide informed assent (adolescents under age 16 years) and/or consent (adolescents over age 16 years; custodial parents or guardians of all adolescent volunteers)
  • ✓ 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)
  • ✕ 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 elevation \> 1.5 times the upper reference range limit. Mild elevations may be seen in adolescent HA and in PCOS, and will be accepted in these groups.

Where it's recruiting

Virginia

Charlottesville

Source: ClinicalTrials.gov · NCT03068910 · last updated 2025-08-05

Hyperandrogenemia and Altered Day-night LH Pulse Patterns · TrialPath