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Recruiting EARLY_Phase 1 NCT03905603

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

Trial Parameters

Condition Polycystic Ovary Syndrome
Sponsor University of Virginia
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 144
Sex FEMALE
Min Age 20 Years
Max Age 49 Years
Start Date 2019-10-08
Completion 2026-04-01
Interventions
ACTHrhCG

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Women with PCOS aged 20-30 years and 40-49 years. Subject is considered to have PCOS if she has current or verifiable history of: a) clinical and/or biochemical evidence of hyperandrogenism plus b) oligomenorrhea (average menstrual cycle length \>45 days or fewer than 9 menses/year) or irregular menstruation (substantially inconsistent menstrual cycle length). Note: For subjects aged 40-49 years, they will be allowed to participate if they have fewer than 10 menses/year (average menstrual cycle length \>35 days) as long as they have a compelling past history of oligomenorrhea or irregular menstruation. * Screening safety labs within normal reference ranges although mild abnormalities that are common in obesity and/or hyperandrogenism will not be grounds for exclusion (see exclusion criteria). * Subjects must be willing and able to provide written informed consent. * Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of the study *

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