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

Sponsor
University of Virginia (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01422707
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
5.9
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS003)
Actual Study Start Date :
Jan 19, 2018
Actual Primary Completion Date :
Jul 17, 2018
Actual Study Completion Date :
Jul 17, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: hydrocortisone

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

Drug: Hydrocortisone
10 mg/m2/per day PO at bedtime (X4 weeks)
Other Names:
  • Cortef

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 18 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Virginia Center for Research in Reproduction Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • University of Virginia

    Investigators

    • Principal Investigator: Christine M. Burt Solorzano, MD, University of Virginia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christine Burt Solorzano, Assistant Professor of Pediatrics, University of Virginia
    ClinicalTrials.gov Identifier:
    NCT01422707
    Other Study ID Numbers:
    • CBS003
    • CBS003
    First Posted:
    Aug 24, 2011
    Last Update Posted:
    Jul 19, 2018
    Last Verified:
    Jul 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Hyperandrogenism
    Overweight
    Hydrocortisone

    Study Results

    No Results Posted as of Jul 19, 2018