Study for the use of spironolactone to regulate menses in girls with excess male hormone

IRB/UVA Tracking #
21768
Principal Investigator
Christine M Burt-Solorzano
Contact
Melissa Gilrain
Contact Phone
434.243.6911
Official Trial Title
Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls with Androgen Excess?
Study Description

UVA Health, Center for Research in Reproduction seeks adolescent girls ages 13-19 who have symptoms of high male hormone for a research study. The purpose of the study is to see if a medication, spironolactone, can normalize ovulation rates in girls with androgen excess. Irregular periods due to problems with ovulation in girls with androgen excess may lead to the development of Polycystic Ovary Syndrome.

You may be eligible for this study if: You have high levels of male hormone. Symptoms and signs of high male hormone include irregular menstrual periods, excess male-patterned hair growth, and/or high testosterone levels. Participants must not take contraceptive pills, hormone medications, or metformin for 3 months prior to the study.

Study involves 3 outpatient study visits over 9 months, then a remote follow-up period of 12 months. Visits will last about 1 hour at the Clinical Research Unit (CRU). The study will include taking spironolactone for four months, blood draws and urine pregnancy tests. Participants will track their periods and collect saliva at home three times a week.

Study-related exams, tests and medications are provided free of charge. For more information please contact pcos@virginia.edu

Compensation

Up to $950