Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

October 26, 2022

Primary Completion Date

October 1, 2025

Study Completion Date

October 1, 2025

Conditions
PCOSPolycystic Ovary Syndrome
Interventions
DRUG

Micronized progesterone

oral micronized progesterone suspension, 100 mg oral dose at 0800 during each study admission

DRUG

Placebo

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

DRUG

Flutamide

Flutamide, 250 mg taken orally twice daily for four weeks before study admission.

DRUG

Estradiol patch

Two 0.1 mg/day transdermal estradiol patches will be applied 3 days prior to each inpatient admission; on the morning of study admission, these two patches will be removed and immediately replaced with two new 0.1 mg/day patches.

Trial Locations (1)

22901

RECRUITING

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