Hyperandrogenemia and Altered Day-night LH Pulse Patterns

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 21, 2016

Primary Completion Date

October 1, 2025

Study Completion Date

December 1, 2025

Conditions
HyperandrogenismPolycystic Ovary SyndromePuberty
Interventions
DRUG

Micronized progesterone

Micronized progesterone 0.8 mg/kg at 0700, 1500, 2300 and 0700 h. Progesterone is a natural hormone.

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

University of Virginia Clinical Research Unit, Charlottesville

All Listed Sponsors
collaborator

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

NIH

lead

University of Virginia

OTHER