Effect of Spironolactone on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess (CBS006)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Whether 12 weeks of spironolactone can reduce androgen production from ovaries and adrenal glands of girls with obesity and androgen excess
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 7
Maximum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Virginia
University of Virginia Center for Research in Reproduction
RECRUITING
Charlottesville
Contact Information
Primary
Melissa Gilrain
pcos@virginia.edu
434-243-6911
Backup
Christine Burt Solorzano, MD
pcos@virginia.edu
434-243-6911
Time Frame
Start Date: 2016-12-09
Estimated Completion Date: 2024-12
Participants
Target number of participants: 20
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University of Virginia