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Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Virginia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Christine Burt Solorzano, University of Virginia
ClinicalTrials.gov Identifier:
NCT01422733
First received: August 22, 2011
Last updated: June 12, 2012
Last verified: June 2012

August 22, 2011
June 12, 2012
Not Provided
Not Provided
Changes in free testosterone or 17 OH progesterone levels after ACTH and r-hCG administration respectively, before and after hydrocortisone administration for 12 weeks [ Time Frame: 12 weeks after hydrocortisone administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01422733 on ClinicalTrials.gov Archive Site
  • Changes in adrenal and ovarian steroid precursors after ACTH and r-hCG; body composition via air displacement plethysmography, BMI, and glucose tolerance testing results; baseline and after 12 weeks of hydrocortisone administration [ Time Frame: 12 weeks after hydrocortisone administration ] [ Designated as safety issue: No ]
  • Morning cortisol [ Time Frame: 72 hours following discontinuation of hydrocortisone ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction
Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction in Overweight Early Pubertal Girls With Androgen Excess (CBS0004)

This study will test whether longer-term suppression of adrenal function can ameliorate androgen (male hormone) overproduction in overweight early pubertal girls with androgen excess. The investigators hypothesize that suppression of nighttime adrenocorticotropin hormone (ACTH) production by 12 weeks of evening 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 ACTH or ovarian stimulation testing with recombinant human chorionic gonadotropin (r-hCG).

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Hyperandrogenemia
  • Obesity
  • Polycystic Ovary Syndrome
  • Drug: Hydrocortisone
    10mg/m2/per day PO at bedtime (X12 weeks)
  • Drug: dexamethasone
    1 mg PO twice
  • Drug: Cosyntropin
    250 micrograms IV twice
  • Drug: r-hCG (Ovidrel)
    25 mcg IV twice
Experimental: hydrocortisone, dexamethasone, Cosyntropin (ACTH), r-hCG
12 weeks hydrocortisone, dexamethasone, and Cosyntropin (ACTH) to perform standardized adrenal stimulation testing, dexamethasone, and r-hCG to perform standardized ovarian stimulation testing
Interventions:
  • Drug: Hydrocortisone
  • Drug: dexamethasone
  • Drug: Cosyntropin
  • Drug: r-hCG (Ovidrel)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
Not Provided
Not Provided

Inclusion Criteria:

  • overweight(>85th BMI%) females
  • Early puberty defined by Tanner 1-2 breast development (expected age range 7-16)
  • 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 LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin and decreased FSH and/or SHBG

Exclusion Criteria:

  • Age < 7 or > 16 y
  • Inability to comprehend what will be done during the study or why it will be done
  • BMI-for-age < 5th percentile
  • Positive pregnancy test or lactation.
  • Screening labs outside of age-appropriate normal range (Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory error)
  • Morning cortisol < 5 µg/dL or history of Cushing syndrome or adrenal insufficiency
  • History of congenital adrenal hyperplasia or 17-hydroxyprogesterone > 295 ng/dL, which suggests the possibility of congenital adrenal hyperplasia (if postmenarcheal, the 17-hydroxyprogesterone will be collected during the follicular phase, or ≥ 40 days since last menses if oligomenorrheic). NOTE: If a 17-hydroxyprogesterone >295 mg/dL is confirmed on repeat testing, an ACTH-stimulated 17-hydroxyprogesterone <1000 ng/dL will be required for study participation.
  • Total testosterone > 150 ng/dL, which suggests the possibility of a virilizing neoplasm
  • DHEAS greater than the upper limit of age-appropriate normal range (mild elevations may be seen in PCOS and adolescent HA, and elevations < 1.5 times the age-appropriate upper limit of normal will be accepted in these groups)
  • Virilization
  • Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c ≥6.5%
  • Abnormal thyroid stimulating hormone (TSH) for age. Subjects with stable and adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded.
  • Abnormal prolactin. Mild elevations may be seen in overweight girls, and elevations <1.5 times the upper limit of normal will be accepted in this group.
  • Persistent hematocrit <36% and hemoglobin <12 g/dL. Subjects with a mildly low hematocrit (33-36%) will be asked to take iron in the form of ferrous gluconate for up to 60 days. Subjects weighing ≤ 36 kg will take one 300-325 mg tablet oral ferrous gluconate daily (containing 36 mg elemental iron);subjects weighing >36 kg will take two 300-325 mg tablets oral ferrous gluconate daily (containing 36 mg elemental iron each). They will return to the CRC after 30-60 days of iron therapy to have their hemoglobin or hematocrit rechecked and will proceed with the remainder of the study if it is ≥12 g/dL or ≥36%, respectively.
  • Persistent liver test abnormalities, with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Mild elevations may be seen in overweight girls, so elevations <1.5 times the upper limit of normal will be accepted in this group.
  • Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
  • Abnormal sodium, potassium, or bicarbonate concentrations, or elevated creatinine concentration (confirmed on repeat)
  • No medications known to affect the reproductive system or glucose metabolism can be taken in the 3 months prior to the study. Such medications include oral contraceptive pills, progestins, metformin, glucocorticoids, and psychotropics.
Female
7 Years to 16 Years
No
Contact: Michelle Y. Abshire, PhD 434-243-6911 pcos@virginia.edu
Contact: Christine Burt Solorzano, MD 434-243-6911 pcos@virginia.edu
United States
 
NCT01422733
CBS004, CBS004
No
Christine Burt Solorzano, University of Virginia
University of Virginia
Not Provided
Principal Investigator: Christine Burt Solorzano, MD University of Virginia
University of Virginia
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP