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

This study is not yet open for participant recruitment.
Verified June 2012 by University of Virginia
Sponsor:
Information provided by (Responsible Party):
Christine Burt Solorzano, University of Virginia
ClinicalTrials.gov Identifier:
NCT01422096
First received: August 19, 2011
Last updated: June 12, 2012
Last verified: June 2012

August 19, 2011
June 12, 2012
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17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration [ Time Frame: 4 weeks after leuprolide ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01422096 on ClinicalTrials.gov Archive Site
Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration [ Time Frame: 4 weeks after leuprolide ] [ Designated as safety issue: No ]
Same as current
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Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS007)

This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one dose of depot leuprolide agonist administration will improve androgen levels in girls with ovarian androgen overproduction. Specifically, this intervention will improve androgen levels after ovarian stimulation testing with recombinant human chorionic gonadotropin (r-hCG).

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Hyperandrogenemia
  • Obesity
  • Polycystic Ovary Syndrome
  • Drug: Leuprolide
    depot leuprolide 11.25 mg if less than or equal to 37.5 kg or 15 mg if > 37.5 kg im once
    Other Name: Depot Lupron
  • Drug: Dexamethasone
    dexamethasone 1 mg PO twice
  • Drug: recombinant human chorionic gonadotropin
    r-hCG 25 micrograms IV twice
    Other Name: Ovidrel
Experimental: leuprolide
leuprolide dexamethasone r-hCG
Interventions:
  • Drug: Leuprolide
  • Drug: Dexamethasone
  • Drug: recombinant human chorionic gonadotropin
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
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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
Female
7 Years to 18 Years
No
Contact: Michelle Y. Abshire, PhD 434-243-6911 pcos@virginia.edu
Contact: Christine M. Burt Solorzano, MD 434-243-6911 pcos@virginia.edu
United States
 
NCT01422096
CBS007, CBS002
No
Christine Burt Solorzano, University of Virginia
University of Virginia
Not Provided
Principal Investigator: Christine M. 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