| Screening visit | Baseline visit | Monthly visit 1 | Monthly visit 2 | Monthly visit 3 and end-of-treatment visit | Follow-up visit |
---|---|---|---|---|---|---|
Physical exam | X | Â | Â | Â | X | X |
Safety labs | X | Â | Â | Â | X | Â |
Transvaginal ultrasound | Â | X | Â | Â | X | X |
Fasting phlebotomy for study parameters | Â | X | Â | Â | X | Â |
Hyperinsulinemiceuglycemic clamp | Â | X | Â | Â | X | Â |
Query for adverse event and concomitant medications | Â | X | X | X | X | X |
Query for menstrual period | X | X | X | X | X | X |
Medication dispensing and accounting | Â | X | X | X | Â | Â |