TableĀ 1

Overview of study visits

Screening visitBaseline visitMonthly visit 1Monthly visit 2Monthly visit 3 and end-of-treatment visit
Physical examinationXX
Safety labs (liver profile: ALT/AST, total bilirubin
Renal profile: BUN or creatinine)
Transvaginal ultrasoundXX
Fasting phlebotomy for study parametersXX
Hyperinsulinaemic euglycemic clampXX
Ask about adverse events and concurrent medicationsXXXX
Ask about menstrual periodXXXXX
Medication dispensing and accountingXXX
  • Physical examination: Height, weight, hip and waist circumference, blood pressure, FG score and acne.

  • Fasting phlebotomy: Serum for the Central Core Laboratory.

  • Transvaginal ultrasound: Endometrial thickness, ovarian volume, antral follicle count and size of ovarian cysts or developing follicles.

  • ALT, alanine transaminase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; FG score, Ferriman-Gallwey score.