Period | Baseline | Inclusion | Treatment | Follow-up | ||||
---|---|---|---|---|---|---|---|---|
Visit | Â | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
Menstrual cycle | −3 month | 0 month | 1 month | 2 month | 3 month | 4 month | 5 month | 6 month |
Patients |  | √ |  |  |  |  |  |  |
Inclusion and exclusion criteria |  | √ |  |  |  |  |  |  |
Informed consent |  | √ |  |  |  |  |  |  |
Physical examination |  | √ |  |  | √ |  |  |  |
Medical history |  | √ |  |  |  |  |  |  |
Comorbidities |  | √ | √ | √ | √ | √ | √ | √ |
Outcomes | Â | Â | Â | Â | Â | Â | Â | Â |
CMSS |  |  | √ | √ | √ | √ | √ | √ |
VAS | √ | √ | √ | √ | √ | √ | √ | √ |
RSS |  | √ |  |  |  |  |  |  |
SDS and SAS |  | √ |  |  | √ |  |  |  |
Dysmenorrhea diary | √ | √ | √ | √ | √ | √ | √ | √ |
PGF2a, PGE2 |  | √ |  |  | √ |  |  |  |
Gynecological abdominal ultrasound B | √ |  |  |  |  |  |  |  |
Trial evaluation | Â | Â | Â | Â | Â | Â | Â | Â |
Patient’s compliance |  |  |  |  | √ |  |  | √ |
Reasons for dropout or withdrawals |  |  |  |  | √ |  |  | √ |
Adverse events |  |  |  |  | √ |  |  |  |
Safety evaluation |  |  |  |  |  |  |  | √ |