Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation
Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much facial and body hair, and weight gain. Women with PCOS also have a hard time becoming pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as adults. Some girls with high levels of male hormone will develop normal hormone levels as they grow up, but most girls continue to have high levels of male hormone as adults. The purpose of this study is to understand where the male and female hormones come from in girls as they get older. The investigators think the adrenal gland, makes most of the hormones in young girls and that the ovary and the adrenal gland make these hormones in older girls. The investigators would like to find out whether an overactive adrenal gland makes these hormones higher in girls who are overweight, compared to those who are not overweight.
Polycystic Ovary Syndrome
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation (JCM022)|
- Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls. [ Time Frame: Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning). ] [ Designated as safety issue: No ]A primary endpoint for analysis in this study is the change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.
- Overnight changes in male and female hormones in response to ACTH suppression [ Time Frame: 14 hours (Sampling begins at 1900 hours and proceeds through 0800 the following morning) ] [ Designated as safety issue: No ]Secondary endpoints will include overnight changes in testosterone, estradiol, cortisol, dehydroepiandrosterone (DHEA), and luteinizing hormone (LH) pulse patterns in response to adrenocorticotropic hormone (ACTH) suppression. These secondary endpoints will be evaluated in a similar manner to the primary endpoint.
- Response to ACTH stimulation in normal weight and overweight girls [ Time Frame: 14 hours (1900 - 0800 hrs) ] [ Designated as safety issue: No ]Examine the differences in hormone responses to ACTH in normal weight and overweight girls.
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Dexamethasone, Cortrosyn
Dexamethasone given 1 mg PO Cortrosyn given single IV bolus 0f 0.25 mg
1 mg PO
Other Name: DexamethasoneDrug: Cortrosyn
single IV bolus of 0.25 mg will be administered
Other Name: ACTH
We propose that the adrenal gland is the predominant source of the early morning rise in progesterone and testosterone which is more marked in early puberty. Specifically, we hypothesize that dexamethasone administration at 22:00 will be associated with a dampened progesterone and testosterone rise the subsequent morning in normal girls. We also propose that the adrenal gland is the source of the excess androgen production in young obese girls, and that dexamethasone will decrease their early morning testosterone and progesterone levels. We will explore the hypothesis that functional adrenal hyperandrogenism, or ACTH hyperresponsiveness, is one mechanism underlying this excess adrenal androgen production seen in obesity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421797
|Contact: Cinthya C Obando Perezemail@example.com|
|Contact: Christine Burt Solorzano, MDfirstname.lastname@example.org|
|United States, Virginia|
|University of Virginia Center for Research in Reproduction||Recruiting|
|Charlottesville, Virginia, United States, 22902|
|Contact: Cinthya Obando Perez 434-243-6911 email@example.com|
|Principal Investigator: John C Marshall, MD, PhD|
|Sub-Investigator: Christine Burt Solorzano, MD|
|Principal Investigator:||John C Marshall, MD, PhD||University of Virginia|