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Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion

NCT04597099 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-11-02

No results posted yet for this study

Summary

This study is trying to find out if flutamide (a medication that blocks the effects of testosterone) may help normalize an aspect of pituitary function (specifically, gonadotropin surge generation) in PCOS. This is a randomized, placebo-controlled, double-blinded, crossover study. The investigators hypothesize that in estradiol-pretreated women with PCOS, acute progesterone augmentation of FSH release (positive feedback) will be enhanced by flutamide.

Conditions

  • PCOS
  • Polycystic 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.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Christopher M McCartney, MD · Univsersity of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2025-10-01
Completion
2025-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597099 on ClinicalTrials.gov