Study of Spironolactone to Improve Progesterones Effect on LH Hormone Patterns in Pubertal Girls with Hyperandrogenism

What this Trial Is About

Researchers are evaluating whether blocking androgen receptors with spironolactone improves progesterones ability to reduce waking luteinizing hormone LH pulse frequency in mid- to late pubertal girls with hyperandrogenism. This randomized, placebo-controlled, double-blinded crossover study focuses on girls who are candidates for spironolactone treatment. The study aims to understand hormonal changes related to hyperandrogenism during puberty. Participants will receive two weeks of pretreatment with either spironolactone 50 mg twice daily or a placebo before each of two 18-hour Clinical Research Unit admissions, which occur in separate menstrual cycles at least two months apart. During admissions, oral micronized progesterone will be administered four times daily at specified times. Blood samples will be collected every 10 minutes overnight to assess LH pulse frequency and other hormone levels. Polysomnography will be done to monitor sleep during admissions. Girls will undergo detailed hormone monitoring during both admissions, with researchers measuring LH pulse frequency while awake as the primary outcome. Secondary measures include LH pulse frequency during sleep. The study includes assessments of hormone levels, sleep patterns, and safety monitoring. Participants will be closely observed throughout the study to evaluate the hormonal effects of spironolactone compared to placebo in response to progesterone. Total participation spans multiple menstrual cycles with careful crossover between treatments.

Hyperandrogenemia and Altered Day-night LH Pulse Patterns