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

Information source: University of Virginia
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperandrogenemia; Obesity; Polycystic Ovary Syndrome

Intervention: Hydrocortisone (Drug); dexamethasone (Drug); Cosyntropin (Drug); r-hCG (Ovidrel) (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: University of Virginia

Official(s) and/or principal investigator(s):
Christine Burt Solorzano, MD, Principal Investigator, Affiliation: University of Virginia

Overall contact:
Michelle Y. Abshire, PhD, Phone: 434-243-6911, Email: pcos@virginia.edu

Summary

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).

Clinical Details

Official title: Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction in Overweight Early Pubertal Girls With Androgen Excess (CBS0004)

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Changes in free testosterone or 17 OH progesterone levels after ACTH and r-hCG administration respectively, before and after hydrocortisone administration for 12 weeks

Secondary outcome:

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

Morning cortisol

Eligibility

Minimum age: 7 Years. Maximum age: 16 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Michelle Y. Abshire, PhD, Phone: 434-243-6911, Email: pcos@virginia.edu

University of Virginia Center for Research in Reproduction, Charlottesville, Virginia 22908, United States; Not yet recruiting
Michelle Y. Abshire, PhD, Phone: 434-243-6911, Email: pcos@virginia.edu
Christine Burt Solorzano, MD, Principal Investigator
John C Marshall, MD, PhD, Sub-Investigator
Additional Information


Last updated: June 12, 2012

Page last updated: November 27, 2014

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