Study of Spironolactone Effects on Sleep-Related Hormone Patterns in Pubertal Girls With Hyperandrogenism

What this Trial Is About

Researchers are evaluating whether spironolactone, an androgen-receptor blocker, can normalize sleep-wake luteinizing hormone LH pulse frequency in mid- to late pubertal girls with hyperandrogenism. The study focuses on adolescent girls aged 10 to 17 who have elevated free testosterone levels or clinical signs of excess androgens. This early phase 1 trial aims to understand how spironolactone affects hormone secretion patterns during sleep and wakefulness in this group. The study uses a randomized, placebo-controlled, double-blinded crossover design. Participants receive either spironolactone 50 mg twice daily or a placebo for two weeks before each of two clinical research unit admissions, spaced at least four weeks apart. During admissions, blood samples are taken every 10 minutes from late afternoon to early morning to measure pulsatile LH secretion, and polysomnography is performed to monitor sleep stages. Participants switch treatments between admissions to compare effects. During the study, participants will undergo close monitoring including frequent blood draws and sleep studies. Researchers will measure changes in sleep-associated and wake-associated LH pulse frequencies and analyze how REM sleep influences LH pulse initiation with and without spironolactone. The primary outcome is the change in sleep-associated LH pulse frequency over about two months. Safety and hormone levels will be carefully observed throughout the trial period.

Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?