Overview of study visits
| Screening visit | Baseline visit | Monthly visit 1 | Monthly visit 2 | Monthly visit 3 and end-of-treatment visit | |
|---|---|---|---|---|---|
| Physical examination | X | X | |||
| Safety labs (liver profile: ALT/AST, total bilirubin Renal profile: BUN or creatinine) | X | X | |||
| Transvaginal ultrasound | X | X | |||
| Fasting phlebotomy for study parameters | X | X | |||
| Hyperinsulinaemic euglycemic clamp | X | X | |||
| Ask about adverse events and concurrent medications | X | X | X | X | |
| Ask about menstrual period | X | X | X | X | X |
| Medication dispensing and accounting | X | X | X |
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.