Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
Condition: PCOS
MeSH terms: Polycystic Ovary Syndrome
Intervention: Dexamethasone; recombinant human chorionic gonadotropin (r-hCG)
Intervention description: Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.; Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
Intervention MeSH terms: Dexamethasone; Chorionic Gonadotropin
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PCOS; oligomenorrhea; irregular menses; hyperandrogenemia; elevated testosterone; adolescents; androgens; ovary; LH

Summary:

      In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is
      excessive ovarian androgen production marked by increased serum testosterone (T) and
      androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis
      that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene
      expression with accentuated 17-hydroxylase activity leading to exaggerated
      17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast,
      T and A responses did not distinguish between PCOS and normal women, although these androgens
      were clearly greater in the former compared to the latter group. As a result, 17P
      responsiveness has been employed to determine the functional capacity of the ovary to produce
      androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a
      dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU. The investigators propose
      to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG
      after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls.
      This will allow for a comparison of these adolescents' ovarian functional capacity to produce
      androgens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal CBC (Hemoglobin must be at least 11mg/dl)

          -  Normal renal and liver function tests

          -  Normal vital signs including normal blood pressure

        Exclusion Criteria:

          -  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)