drugset / Trial / NCT04723862
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
Phase 0
Recruiting
32 enrolled
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedCrossoverQuadruple-blindBasic science
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).
Timeline
- Start
- 2021-11-12
- Primary completion
- 2025-10-01
- Completion
- 2025-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Spironolactone | Small molecule | 50 mg | Oral |