Table 1.
Overview of study visits
| Screening visit | Baseline visit | Monthly visit 1 | Monthly visit 2 | Monthly visit 3 and end-of-treatment visit | Follow-up visit | |
|---|---|---|---|---|---|---|
| Physical exam |
X |
|
|
|
X |
X |
| Safety labs |
X |
|
|
|
X |
|
| Transvaginal ultrasound |
|
X |
|
|
X |
X |
| Fasting phlebotomy for study parameters |
|
X |
|
|
X |
|
| Hyperinsulinemiceuglycemic clamp |
|
X |
|
|
X |
|
| Query for adverse event and concomitant medications |
|
X |
X |
X |
X |
X |
| Query for menstrual period |
X |
X |
X |
X |
X |
X |
| Medication dispensing and accounting | X | X | X |
Physical examination: Height, weight, hip and waist circumference, blood pressure, FG score, 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.