Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Withdrawn before enrolling · Early Phase 1
Conditions studied: Hyperandrogenemia, Obesity, Polycystic Ovary Syndrome
In brief
Short term hydrocortisone to test whether improves excess androgen production from adrenal gland and ovaries
Key facts
- Study ID
- NCT01422707
- Run by
- University of Virginia
- People needed
- 0
- Starts
- 2018-01-19
- Expected to finish
- 2018-07-17
- Last updated by the study team
- 2018-07-19
Who can join
Age: 7 and older, up to 18. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Virginia Center for Research in Reproduction — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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