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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01422707 |
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Date of registration:
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19/08/2011 |
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Primary sponsor: |
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Public title:
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Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
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Scientific title:
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Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS003) |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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20 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01422707 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Michelle Y. Abshire, PhD |
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Address:
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Telephone:
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434-243-6911 |
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Email:
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pcos@virginia.edu |
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Affiliation:
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Name:
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Michelle Y. Abshire, PhD |
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Address:
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Telephone:
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434-243-6911 |
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Email:
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pcos@virginia.edu |
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Affiliation:
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Name:
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Christine M. Burt Solorzano, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Virginia |
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Key inclusion & exclusion criteria
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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 LH, lipids, testosterone, prolactin, DHEAS, E2,
glucose, and insulin and decreased FSH and/or 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
Age minimum:
7 Years
Age maximum:
18 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hyperandrogenemia
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Obesity
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Polycystic Ovary Syndrome
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Intervention(s)
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Drug: Cosyntropin (ACTH)
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Drug: dexamethasone
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Drug: Hydrocortisone
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Primary Outcome(s)
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Changes in Free testosterone after ACTH administration before and after hydrocortisone administration for 4 weeks
[Time Frame: 30 and 60 minutes after ACTH, baseline and after 4 weeks of hydrocortisone administration]
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Secondary Outcome(s)
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Changes in adrenal steroid precursors after ACTH, baseline and after 4 weeks of hydrocortisone administration
[Time Frame: 30 and 60 minutes after ACTH, baseline and after 4 weeks of hydrocortisone administration]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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