ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Spironolactone on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess

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.
ClinicalTrials.gov Identifier: NCT01422759
Recruitment Status : Recruiting
First Posted : August 24, 2011
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Christine Burt Solorzano, University of Virginia

August 22, 2011
August 24, 2011
January 23, 2018
November 2016
June 2019   (Final data collection date for primary outcome measure)
Changes in free testosterone and 17-hydroxyprogesterone levels after ACTH and rhCG administration respectively, before and after spironolactone administration for 12 weeks [ Time Frame: 12 weeks after spironolactone treatment ]
Changes in free testosterone and 17 OH progesterone levels after ACTH and r-hCG administration respectively, before and after spironolactone administration for 12 weeks [ Time Frame: 12 weeks after spironolactone treatment ]
Complete list of historical versions of study NCT01422759 on ClinicalTrials.gov Archive Site
Changes in adrenal and ovarian steroid precursors after ACTH and rhCG; body composition via air displacement plethysmography, BMI, and glucose tolerance testing results; baseline and after 12 weeks of spironolactone administration [ Time Frame: 12 weeks after spironolactone administration ]
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 spironolactone administration [ Time Frame: 12 weeks after spironolactone administration ]
Not Provided
Not Provided
 
Effect of Spironolactone on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess
Effect of Spironolactone on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess (CBS006)
Whether 12 weeks of spironolactone can reduce androgen production from ovaries and adrenal glands of girls with obesity and androgen excess
This study will test whether spironolactone administration can ameliorate androgen (male hormone) overproduction in overweight pubertal girls with androgen excess. The investigators hypothesize that reduction in P450c17alpha overactivity and androgen receptor blockade by 12 weeks of spironolactone administration will improve androgen levels after adrenal stimulation testing with adrenocorticotropic hormone (ACTH) and ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Obesity
  • Hyperandrogenemia
  • Polycystic Ovary Syndrome
Drug: Spironolactone
50-100 mg PO BID (X 12 weeks)
Other Name: Aldactone
Experimental: spironolactone
12 weeks spironolactone with pre- and post-intervention dexamethasone, and ACTH to perform standardized adrenal stimulation testing; dexamethasone and rhCG to perform standardized ovarian stimulation testing
Intervention: Drug: Spironolactone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Same as current
December 2019
June 2019   (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:

  • Age < 7 or > 18 years
  • 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.
  • Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory error.
  • Morning cortisol < 3 µg/dL or history of Cushing syndrome or adrenal insufficiency
  • History of congenital adrenal hyperplasia or 17-hydroxyprogesterone > 300 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 >300 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 Polycystic Ovary Syndrome (PCOS) and adolescent Hyperandrogenemia (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 Clinical Research Unit (CRU) 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.
Sexes Eligible for Study: Female
7 Years to 18 Years   (Child, Adult)
No
Contact: Deborah Sanderson 434-243-6911 pcos@virginia.edu
Contact: Christine Burt Solorzano, MD 434-243-6911 pcos@virginia.edu
United States
 
 
NCT01422759
19258
CBS005 ( 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 Burt Solorzano, MD University of Virginia
University of Virginia
January 2018

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