Blood Vessel Function in Adolescents and Women With Polycystic Ovary Syndrome

Stopped early

Conditions studied: Polycystic Ovary Syndrome (PCOS)

In brief

The purpose of this study is to determine if changes in blood vessel health lead to the menstrual irregularities that women with PCOS experience. This research study will help determine if women with PCOS have early changes in their blood vessels called "endothelial dysfunction," and if the number of progenitor cells (cells that in a healthy person repair blood vessel damage) are related to these blood vessel changes. To do so, we will compare ultrasound (soundwave) pictures of a large blood vessel in the arm and the results of blood tests between women with PCOS and other healthy women with normal menstrual periods.

Key facts

Study ID

NCT01615562

Run by

Virginia Commonwealth University

People needed

18

Starts

2011-12-01

Expected to finish

2015-07-01

Last updated by the study team

2015-12-14

Who can join

Age: 14 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• PCOS as defined by NIH/NICHD criteria: 1) oligo- or amenorrhea (≤8 menstrual periods annually, persisting 2 years post menarche); 2) biochemical hyperandrogenism(HA), i.e.,elevated total or free testosterone concentration and/or clinical evidence of HA (defined as the presence of hirsutism); and 3) exclusion of secondary causes of ovulatory dysfunction and HA (including hyperprolactinemia, thyroid dysfunction, non-classical congenital adrenal hyperplasia (NCAH) due to 21-hydroxylase deficiency, Cushing syndrome, androgen secreting neoplasms, and androgenic/anabolic drug use).
• Inclusion criteria for adolescent and adult control subjects will include 1) normal menstrual periods (defined as regular cycles between 22-36 days in length); 2) normal serum androgens (total/free testosterone and dehydroepiandrosterone-sulfate [DHEA-S]); and 3) absence of clinical evidence of hyperandrogenism. Additionally, adolescent controls must be 2 years post menarche.

You may not qualify if…

• Diabetes mellitus
• Underlying endocrine, neurologic, and/or genetic syndromes leading to obesity
• Congenital heart disease or abnormal resting ECG
• Renal or hepatic disease
• History of rheumatologic disorders or malignancy
• Use of medications or dietary supplements known to affect insulin sensitivity (i.e. metformin, corticosteroids, and oral contraceptive pills), blood pressure, or cholesterol within 3 months of study participation
• Investigation drug use within 3 months of study participation
• Pregnancy
• Current tobacco use

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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