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

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ClinicalTrials.gov Identifier: NCT01422707
Recruitment Status : Withdrawn (The study team decided not to pursue this study.)
First Posted : August 24, 2011
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Christine Burt Solorzano, University of Virginia

Tracking Information
First Submitted Date  ICMJE August 19, 2011
First Posted Date  ICMJE August 24, 2011
Last Update Posted Date July 19, 2018
Actual Study Start Date  ICMJE January 19, 2018
Actual Primary Completion Date July 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2011)
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 ]
Change History Complete list of historical versions of study NCT01422707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2011)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Official Title  ICMJE Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS003)
Brief Summary Short term hydrocortisone to test whether improves excess androgen production from adrenal gland and ovaries
Detailed Description This study will test whether short-term suppression of adrenal function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one month of 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 adrenocorticotropin hormone (ACTH).
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Hyperandrogenemia
  • Obesity
  • Polycystic Ovary Syndrome
Intervention  ICMJE Drug: Hydrocortisone
10 mg/m2/per day PO at bedtime (X4 weeks)
Other Name: Cortef
Study Arms  ICMJE Experimental: hydrocortisone
4 weeks hydrocortisone with pre- and post-intervention Dexamethasone and Cosyntropin to perform standardized adrenal stimulation testing
Intervention: Drug: Hydrocortisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 17, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2011)
20
Actual Study Completion Date  ICMJE July 17, 2018
Actual Primary Completion Date July 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 7 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01422707
Other Study ID Numbers  ICMJE CBS003
CBS003 ( Other Identifier: University of Virginia )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christine Burt Solorzano, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christine M. Burt Solorzano, MD University of Virginia
PRS Account University of Virginia
Verification Date July 2018

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