Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
Trial Parameters
Brief Summary
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).
Eligibility Criteria
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 study period. Exclusion Criteria: * Inability/incapacity to provide informed consent * Males will be excluded (hyperandrogenism is unique to females) * Age \< 10 or \> 17 years (this study is designed to elucidate mechanisms underlying emerging PCOS in mid- to late pubertal adolescent girls * Post-menarcheal by \> 4 years * Obesity resulting from a well-defined endocrinopathy, or genetic syndrome *