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Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Diego
Information provided by (Responsible Party):
John Marshall, University of Virginia Identifier:
First received: August 19, 2011
Last updated: December 7, 2015
Last verified: December 2015
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.

Condition Intervention
Polycystic Ovary Syndrome
Drug: Dexamethasone
Drug: Cortrosyn

Study Type: Interventional
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)

Resource links provided by NLM:

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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). ]
    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.

Secondary Outcome Measures:
  • 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) ]
    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) ]
    Examine the differences in hormone responses to ACTH in normal weight and overweight girls.

Estimated Enrollment: 84
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)
Arms Assigned Interventions
Experimental: Dexamethasone, Cortrosyn
Dexamethasone given 1 mg PO Cortrosyn given single IV bolus 0f 0.25 mg
Drug: Dexamethasone
1 mg PO
Drug: Cortrosyn
single IV bolus of 0.25 mg will be administered
Other Name: ACTH

Detailed Description:
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.

Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Normal and obese (>95th BMI%) females
  • Weight of 24 kg or more
  • Early to late puberty (expected age range 7-18)
  • Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)

Exclusion Criteria:

  • Screening labs outside of age-appropriate normal range
  • Hemoglobin <12 mg/dL and hematocrit<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still <36%, they will be excluded.)
  • Morning Cortisol <5 g/dL
  • 17-hydroxyprogesterone >295 ng/dL
  • Weight<24 kg
  • History of Cushing's syndrome or adrenal insufficiency
  • Pregnant (self reported)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01421797

Contact: Cinthya C Obando Perez 434-243-6911
Contact: Christine Burt Solorzano, MD 434-243-6911

United States, Virginia
University of Virginia Center for Research in Reproduction Recruiting
Charlottesville, Virginia, United States, 22902
Contact: Cinthya Obando Perez    434-243-6911   
Principal Investigator: John C Marshall, MD, PhD         
Sub-Investigator: Christine Burt Solorzano, MD         
Sponsors and Collaborators
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Diego
Principal Investigator: John C Marshall, MD, PhD University of Virginia
  More Information

Responsible Party: John Marshall, Director, Center for Research in Reproduction, University of Virginia Identifier: NCT01421797     History of Changes
Other Study ID Numbers: 12702  JCM022  U54HD028934-18  12702 
Study First Received: August 19, 2011
Last Updated: December 7, 2015

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on February 17, 2017