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

University of Virginia

Status and phase: Withdrawn; Early Phase 1

Conditions: Hyperandrogenemia; Polycystic Ovary Syndrome; Obesity

Treatments: Drug: Hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT01422707

CBS003 (Other Identifier)

Details and patient eligibility

About

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

Full 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 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 (ACTH).

Sex: Female

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

hydrocortisone

Experimental group

Description:

4 weeks hydrocortisone with pre- and post-intervention Dexamethasone and Cosyntropin to perform standardized adrenal stimulation testing

Treatment:

Drug: Hydrocortisone