Overview of the study visits
Screening visit | Baseline visit | Monthly visit 1 | Monthly visit 2 | Monthly visit 3 | Monthly visit 4 | Monthly visit 5 | Monthly visit 6 | End of treatment visit | |
---|---|---|---|---|---|---|---|---|---|
Visit number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
Sign consent | × | ||||||||
Urine pregnancy test | × | × | × | × | × | × | × | × | |
Physical examination and history | × | × | |||||||
Transvaginal ultrasound | × | × | × | ||||||
Semen analysis | × | ||||||||
Hysterosalpingogram or sonohysterogram | × | ||||||||
Safety eligibility tests | × | × | × | ||||||
Fasting phlebotomy for study parameters | × | × | × | ||||||
Progesterone level | × | × | × | × | × | × | × | ||
Quality of life measures | × | × | × | ||||||
Assess adverse events | × | × | × | × | × | × | × | ||
Record concomitant medications | × | × | × | × | × | × | × | × | × |