drugset / Trial / NCT03068910
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
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, androgen-receptor blockade (spironolactone) improves the ability of progesterone to acutely reduce waking luteinizing hormone pulse frequency (primary endpoint).
Timeline
- Start
- 2016-07-21
- Primary completion
- 2025-10-01
- Completion
- 2025-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Spironolactone | Small molecule | 50 mg | Oral |
| Background | Progesterone | Other / unclassified | 0.8 mg/kg | Oral |