University of Virginia
The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism (HA), androgen-receptor blockade (spironolactone) alone normalizes sleep-wake luteinizing hormone (LH) pulse frequency (primary endpoint) and overall LH and follicle-stimulating hormone secretion (secondary endpoints).
This is a randomized, placebo-controlled, double-blinded crossover study to test the following hypothesis: In mid- to late pubertal girls with hyperandrogenism, spironolactone (50 mg twice daily) for 2 weeks will reduce sleep-associated luteinizing hormone (LH) pulse frequency compared to placebo treatment. To test this hypothesis, 16 late pubertal girls (signified by either \[a\] post-menarcheal status \[Tanner breast stages 2-5\] or \[b\] Tanner breast stage of 4 or 5 \[whether pre-menarcheal or post-menarcheal\], but no more than 4 years post-menarcheal) with hyperandrogenism (serum \[calcu…
Inclusion Criteria: * Mid- to late pubertal adolescent girls as signified by either (a) post-menarcheal status (Tanner breast stages 2-5) or (b) Tanner breast stage of 4 or 5 (whether pre-menarcheal or post-menarcheal) ages 10-17 years. * Hyperandrogenism, defined as a serum (calculated) free testosterone concentration greater than the Tanner stage-specific reference range and/or clinical hirsutism * General good health (excepting obesity, hyperandrogenism, PCOS, and adequately-treated hypothyroidism) * Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the s…
Spironolactone is an androgen-receptor blocker commonly used (off-label) for hyperandrogenism. The spironolactone dose will be 50 mg taken orally twice daily (for two weeks before admission to the Clinical Research Unit).
Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.
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