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Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01422707
Recruitment Status : Withdrawn (The study team decided not to pursue this study.)
First Posted : August 24, 2011
Last Update Posted : July 19, 2018
Information provided by (Responsible Party):
Christine Burt Solorzano, University of Virginia

Brief Summary:
Short term hydrocortisone to test whether improves excess androgen production from adrenal gland and ovaries

Condition or disease Intervention/treatment Phase
Hyperandrogenemia Obesity Polycystic Ovary Syndrome Drug: Hydrocortisone Early Phase 1

Detailed Description:
This study will test whether short-term suppression of adrenal function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one month of oral hydrocortisone administration will improve androgen levels in girls with adrenal androgen overproduction. Specifically, this intervention will improve androgen levels after adrenal stimulation testing with adrenocorticotropin hormone (ACTH).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS003)
Actual Study Start Date : January 19, 2018
Actual Primary Completion Date : July 17, 2018
Actual Study Completion Date : July 17, 2018

Arm Intervention/treatment
Experimental: hydrocortisone
4 weeks hydrocortisone with pre- and post-intervention Dexamethasone and Cosyntropin to perform standardized adrenal stimulation testing
Drug: Hydrocortisone
10 mg/m2/per day PO at bedtime (X4 weeks)
Other Name: Cortef

Primary Outcome Measures :
  1. Changes in free testosterone after ACTH administration before and after hydrocortisone administration for 4 weeks [ Time Frame: 30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration ]

Secondary Outcome Measures :
  1. Changes in adrenal steroid precursors after ACTH, baseline, and after 4 weeks of hydrocortisone administration [ Time Frame: 30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration ]

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Overweight(>85th BMI%) females
  • Early to late puberty (expected age range 7-18)
  • Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
  • 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 luteinizing hormone (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
  • History of Cushing's syndrome or adrenal insufficiency
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01422707

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United States, Virginia
University of Virginia Center for Research in Reproduction
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
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Principal Investigator: Christine M. Burt Solorzano, MD University of Virginia

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Responsible Party: Christine Burt Solorzano, Assistant Professor of Pediatrics, University of Virginia Identifier: NCT01422707     History of Changes
Other Study ID Numbers: CBS003
CBS003 ( Other Identifier: University of Virginia )
First Posted: August 24, 2011    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Body Weight
Signs and Symptoms
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Epinephryl borate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents