Clinical Trial: Ovarian Contribution to Androgen Production in Adolescent Girls
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Ovarian Contribution to Androgen Production in Adolescent Girls
Brief Summary: Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body hair, irregular menstrual periods, or no menstrual periods excess body weight, and infertility. It also results in elevated androgen levels such as testosterone. In women with PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown whether the ovaries are fully active during early puberty. The purpose of this study is to determine how the ovaries contribute to the production of male hormones in the body during different stages of puberty, so that it can be better understood why some females have excess androgens.
Detailed Summary: Adolescent hyperandrogenemia can represent a forerunner to adult PCOS. Because adrenarche leads to an increase in adrenal androgen production during early puberty and since early puberty is associated with an overnight rise in testosterone that follows a similar time course to cortisol, we hypothesize that the adrenal gland is a major source of androgens in early puberty. On the other hand, the overnight rise in testosterone may reflect an ovarian response to overnight increases of gonadotropin secretion in early puberty. However, the ability of the ovaries to produce androgens (e.g., to respond to gonadotropin stimulation) during early puberty has not been tested concurrently in these girls. The sources of excess androgen production and the timing of their relative contributions across puberty are important in understanding the mechanism of hyperandrogenemia in these individuals. In addition, determination of the sources of hyperandrogenemia across puberty may have clinical utility in the development of preclinical screening tests designed to reveal those girls at greatest risk for PCOS and identification of potential therapeutic targets to prevent its development.
Sponsor: University of Virginia
Current Primary Outcome: Assess baseline and stimulated ovarian hormone levels in response to recombinant human chorionic gonadotropin (rhCG) administration in normal weight and overweight girls across puberty [ Time Frame: 24 hours after administration of rhCG administration ]
Original Primary Outcome: Assess baseline and stimulated ovarian hormone levels in response to recombinant human chorionic gonadotropin administration in normal weight and overweight girls across puberty [ Time Frame: 24 hours after administration of human chorionic gonadotropin (r-hCG) administration ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Virginia
Dates:
Date Received: August 17, 2011
Date Started: December 2010
Date Completion: December 2018
Last Updated: December 16, 2016
Last Verified: December 2016
