Ensayos clínicos

Inclusion Criteria:

• Male and female adults; premenopausal women.
• Age 18 – 50 years.
• Due to rare presentation of IIH, we will also include men with IIH and women older than 50 for genetic data and to compare to astronaut data.
• PCOS: PCOS criteria of both oligomenorrhea (<9 menses per year) and androgen excess [clinical hirsutism (Ferriman-Gallway score >8 or severe acne) or elevated testosterone].  Prior use of any medications for the treatment of PCOS  should have been discontinued at least three months prior to participation. Participants that have >9 menses per year who meet other PCOS criteria will be given option of having progesterone test drawn between days 20 and 22 of menstrual cycle to confirm anovulatory status.
• IIH: Patients will be classified as having IIH if they meet the Modified Dandy criteria, which includes signs and symptoms of increased intracranial pressure, no localizing neurologic finding except CN VI palsies, normal neuroimaging, lumbar puncture opening pressure >250 mm Hg with normal CSF, and no other cause present.  Patients presenting with papilledema and borderline opening pressures (200-250 mm Hg) will also be classified as having IIH. 
• Control subjects will be matched for age and BMI, and will not have PCOS or IIH, as defined by criteria above.

Exclusion Criteria:

• Diagnosis of Cushing’s syndrome.
• Untreated hypo/hyperthyroidism.
• Elevated prolactin.
• Congenital adrenal hyperplasia.
• Renal insufficiency (creatinine > 1.5).
• Diabetes.
• No medications that can affect androgen concentrations or insulin sensitivity.
• Patients cannot be pregnant, breast-feeding, or taking oral contraceptives.
• Participants cannot be on medications that affect folate or B12 metabolism, such as:
  • Methotrexate;
  • Trimethoprim;
  • Triamterene;
  • Phenobarbital;
  • Phenytoin;
  • Carbamazepine;
  • Gabapentin;
  • Primidone.
• In the interest of promoting recruitment for individuals diagnosed with the rare condition of IIH, IIH patients receiving topiramate treatment or any treatment for PCOS will not be excluded from participation in the study.