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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by University of Virginia.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Christine Burt Solorzano, University of Virginia Identifier:
First received: August 19, 2011
Last updated: June 12, 2012
Last verified: June 2012
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.

Condition Intervention
Polycystic Ovary Syndrome
Drug: Hydrocortisone
Drug: dexamethasone
Drug: Cosyntropin (ACTH)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS003)

Resource links provided by NLM:

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Arms Assigned Interventions
Experimental: hydrocortisone, dexamethasone, cosyntropin (ACTH)
4 weeks hydrocortisone Dexamethasone and Cosyntropin to perform standardized adrenal stimulation testing
Drug: Hydrocortisone
10 mg/m2/per day PO at bedtime (X4 weeks)
Drug: dexamethasone
1 mg PO twice
Drug: Cosyntropin (ACTH)
250 micrograms IV twice


Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Genders 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 LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin and decreased FSH and/or 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
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Please refer to this study by its identifier: NCT01422707

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

Responsible Party: Christine Burt Solorzano, Assistant Professor of Pediatrics, University of Virginia Identifier: NCT01422707     History of Changes
Other Study ID Numbers: CBS003  CBS003 
Study First Received: August 19, 2011
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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
Dexamethasone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Dexamethasone 21-phosphate
BB 1101
Racepinephrine processed this record on December 02, 2016