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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 December 2016 by Christine Burt Solorzano, University of Virginia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01422096
First Posted: August 23, 2011
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Christine Burt Solorzano, University of Virginia
August 19, 2011
August 23, 2011
December 20, 2016
June 2017
June 2018   (Final data collection date for primary outcome measure)
17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration [ Time Frame: 4 weeks after leuprolide ]
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 ]
Same as current
Not Provided
Not Provided
 
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 (rhCG).
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (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
Experimental: leuprolide
leuprolide 11.25 mg IM with adrenal suppression/stimulation testing with dexamethasone/Cortrosyn and ovarian stimulation testing with r-hCG before and 3 weeks after injection
Intervention: Drug: Leuprolide
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
June 2019
June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
7 Years to 18 Years   (Child, Adult)
No
Contact: Deborah Sanderson 434-243-6911 pcos@virginia.edu
Contact: Christine M. Burt Solorzano, MD 434-243-6911 pcos@virginia.edu
United States
 
 
NCT01422096
CBS007
CBS007 ( Other Identifier: University of Virginia )
No
Not Provided
Plan to Share IPD: 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
December 2016

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