Status:
WITHDRAWN
Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Lead Sponsor:
University of Virginia
Conditions:
Hyperandrogenemia
Obesity
Eligibility:
FEMALE
7-18 years
Phase:
EARLY_PHASE1
Brief Summary
Short term hydrocortisone to test whether improves excess androgen production from adrenal gland and ovaries
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01422707
Start Date
January 19 2018
End Date
July 17 2018
Last Update
July 19 2018
Active Locations (1)
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1
University of Virginia Center for Research in Reproduction
Charlottesville, Virginia, United States, 22908