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Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS

NCT03905603 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-11-03

No results posted yet for this study

Summary

The objective of the study is to determine the relative contributions of four established predictors of hyperandrogenism (luteinizing hormone \[LH\] secretion, ovarian response to recombinant human chorionic gonadotropin \[r-hCG\] administration, adrenal response to adrenocorticotropic hormone \[ACTH\] administration, and hyperinsulinemia) in older vs. young women with Polycystic Ovary Syndrome (PCOS) in a cross-sectional, physiological study. The investigators hypothesize that hyperinsulinemia is a stronger independent predictor of free testosterone (T) in older reproductive aged (vs. young) women with PCOS.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

ACTH

ACTH (Cosyntropin) 250 mcg will be given once during the study.

DRUG

rhCG

rhCG (Ovidrel) 250 mcg will be given once during the study.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Chris McCartney, MD · University of Virginia

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2026-04-01
Completion
2026-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03905603 on ClinicalTrials.gov