Does Spironolactone Normalize Sleep-wake Luteinizing Hormone (LH) Pulse Frequency in Pubertal Girls With Hyperandrogenism? (CBS010)
University of Virginia
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).
Description
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…
Eligibility
- Age range
- 10–17 years
- Sex
- Female
- Healthy volunteers
- Yes
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…
Interventions
- DrugSpironolactone
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).
- DrugPlacebo
Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.
Location
- Center for Research in Reproduction, University of VirginiaCharlottesville, Virginia