Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
The purpose of this study is to understand the effects of elevated male hormones in adolescent girls and how they effect the development of polycystic ovary syndrome (PCOS). If the investigators understand the effects of elevated male hormones levels in girls, the investigators may be able to better treat girls with elevated male hormone levels and perhaps even learn how to prevent the development of PCOS. Females with elevated levels of male hormones respond differently to estrace (estradiol) and progesterone than females with normal male hormone levels. The investigators will be giving you estrogen and progesterone to see how you respond after the male hormone has been blocked by a medication called flutamide.
Polycystic Ovary Syndrome
Drug: estrace (estradiol)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Effect of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone in Hyperandrogenic Adolescent Girls (JCM021)|
- Slope of the percent change in luteinizing hormone (LH) pulses as a function of day 7 progesterone level [ Time Frame: 3 weeks after flutamide treatment ] [ Designated as safety issue: No ]The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Flutamide, estrace, progesterone
For flutamide, subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day for approximately 3 weeks.
Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission.
Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.
Subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day.Drug: Progesterone
oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven daysDrug: estrace (estradiol)
0.5-1 mg once a day for seven days
|Contact: Anne C Gabel, BScfirstname.lastname@example.org|
|Contact: John C. Marshall, MD, PhDemail@example.com|
|United States, Virginia|
|Center for Research in Reproduction, University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Anne C Gabel, BSc 434-243-6911 firstname.lastname@example.org|
|Principal Investigator: John C. Marshall, MD, PhD|
|Sub-Investigator: Christine M Burt Solorzano, MD|