Effect of Spironolactone on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls W… (NCT01422759) | Clinical Trial Compass
UnknownNot Applicable
Effect of Spironolactone on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess
United States20 participantsStarted 2016-12-09
Plain-language summary
Whether 12 weeks of spironolactone can reduce androgen production from ovaries and adrenal glands of girls with obesity and androgen excess
Who can participate
Age range7 Years – 18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 test…
What they're measuring
1
Changes in free testosterone and 17-hydroxyprogesterone levels after ACTH and rhCG administration respectively, before and after spironolactone administration for 12 weeks
Timeframe: 12 weeks after spironolactone treatment