Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
Condition: PCOS
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.We 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.
    

Intervention name(s): Dexamethasone; recombinant human chorionic gonadotropin (r-hCG)
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): recombinant human chorionic gonadotropin (r-hCG); Ovidrel
Intervention MeSH terms: Dexamethasone; Chorionic Gonadotropin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PCOS; oligomenorrhea; irregular menses; hyperandrogenemia; elevated testosterone; adolescents; androgens; ovary; LH