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

Who is this study for? Patients with Polycystic Ovary Syndrome
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 49
Healthy Volunteers: t
View:

• 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

• Willingness and ability to comply with scheduled visits and study procedures

Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Melissa G Gilrain, BS
pcos@virginia.edu
434-243-6911
Time Frame
Start Date: 2019-10-08
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 144
Treatments
Experimental: ACTH (Cosyntropin), rhCG (Ovidrel)
ACTH (Cosyntropin) administered 250 mcg IV; rhCG (Ovidrel) administered 250 mcg IV
Authors
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov