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

• Status: Withdrawn
• Trial end date: 2018-07-17
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Androgens; Cortisol succinate; Epinephrine; Epinephryl borate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Racepinephrine

Criteria

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