RecruitingPubertyHyperandrogenism
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
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 two-fold. (1) We will determine if in mid- to late pubertal girls without hyperandrogenism (HA), progesterone (P4) acutely reduces waking luteinizing hormone (LH) frequency to a greater extent than sleep-associated LH frequency. (2) We will determine if in mid- to late pubertal girls with HA, P4 will acutely suppress waking LH frequency to a lesser degree than it does in girls without HA.
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)
- ✓ For girls without hyperandrogenism: serum (calculated) free testosterone concentration within the Tanner stage-specific reference range and the absence of hirsutism
- ✓ For girls with hyperandrogenism: 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 · NCT00929006 · last updated 2025-08-05