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

Early Phase 1

Withdrawn

• Conditions: Hyperandrogenemia; Obesity; Polycystic Ovary Syndrome
• Interventions: Drug: Hydrocortisone

• Registration Number: NCT01422707
• Lead Sponsor: University of Virginia

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 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).

Study Timeline

• Study First Submitted: 2011-08-19
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Study Start: 2018-01-19
• Status Verified: 2018-07
• Primary Completion: 2018-07-17
• Study Completion: 2018-07-17
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in free testosterone after ACTH administration before and after hydrocortisone administration for 4 weeks	30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration

Secondary Outcome Measures

Name	Time	Method
Changes in adrenal steroid precursors after ACTH, baseline, and after 4 weeks of hydrocortisone administration	30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration

Trial Locations

Locations (1)

University of Virginia Center for Research in Reproduction; 🇺🇸 Charlottesville, Virginia, United States