NCT04723862View on ClinicalTrials.gov

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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 12, 2021

Primary Completion Date

October 1, 2025

Study Completion Date

December 1, 2025

Conditions
HyperandrogenismPolycystic Ovary SyndromePuberty
Interventions
DRUG

Spironolactone

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).

DRUG

Placebo

Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.

Trial Locations (1)

22908

RECRUITING

Center for Research in Reproduction, University of Virginia, Charlottesville

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Virginia

OTHER