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Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS003)

7 Years
18 Years
Not Enrolling
Hyperandrogenemia, Obesity, Polycystic Ovary Syndrome

Thank you

Trial Information

Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS003)

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Changes in Free testosterone after ACTH administration before and after hydrocortisone administration for 4 weeks

Outcome Time Frame:

30 and 60 minutes after ACTH, baseline and after 4 weeks of hydrocortisone administration

Safety Issue:


Principal Investigator

Christine M. Burt Solorzano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia


United States: Institutional Review Board

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Hyperandrogenemia
  • Obesity
  • Polycystic Ovary Syndrome
  • Obesity
  • Polycystic Ovary Syndrome
  • Overweight



University of Virginia Center for Research in Reproduction Charlottesville, Virginia  22902