The Adrenal Contribution to Androgen Production in Girls During Puberty
Completed · Phase 3
Conditions studied: Development
In brief
In girls with elevated androgens the precise source of androgen excess throughout puberty and early adolescence has not been carefully examined. The investigators propose to examine whether the adrenal gland produces the majority of androgens during puberty by studying the differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare steroid changes before and 60 min after ACTH administration in NW and OB girls.
Key facts
- Study ID
- NCT01062568
- Run by
- University of California, San Diego
- People needed
- 50
- Starts
- 2010-02-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2019-08-26
Who can join
Age: 7 and older, up to 18. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Normal CBC (Hemoglobin must be at least 11mg/dl)
- Normal renal and liver function tests (AST\& ALT 10-45 IU/L; Albumin 3.3-5 g/dL; Alk phos 30-130 IU/L;
- direct bili <0.2 mg/dL;
- total bili <1.2 mg/dL; total protein 6.0-8.0 g/dL) Normal vital signs including normal blood pressure (pulse 60-100/min, respirations 12-20/min, BP 80/60-130/80)
You may not qualify if…
- Pregnancy
- On oral contraceptives
- On insulin lowering drugs
- On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
- On medications that will influence androgen metabolism or clearance
- On medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconazole, etc)
- Subjects with morning cortisol<5 ug/dL will be excluded and asked to see their primary care physician.
- Subjects with 17-OHP>250 ng/dL) will be excluded and asked to see their primary care physician.
- Subject with a history of Cushing syndrome or adrenal insufficiency will be excluded
Where it is running
- University of california, san diego — La Jolla, California, United States
Full record on ClinicalTrials.gov
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