Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Pain severity. Pain resolution time (pain analogue scale: Much better, Better, No change, Worse, Much worse). Measurement time: on the 3rd, 5th, 10th day and on the 15th day. Measurement time: on the 3rd, 5th, 10th day and on the 15th day.
Key secondary outcomes:
Evolution of ultrasound findings (transvaginal ultrasound). Measurement time: baseline and after 5 days of treatment.
Adverse Events-AE (Occurrence of any AE in the subject (yes/no); Description of the AE (Name of the adverse event); Duration of the AE (Difference in dates between the start and end of the event); Intensity of the AE (Mild , Moderate, Severe); AE severity (Serious/serious, Not serious/not serious); Attitude towards study treatment (no change, dose modification, temporary or permanent discontinuation of study treatment); AE outcome (recovered , improved, persists or sequelae); Causal relationship (1.Very Probable, 2.Probable, 3.Possible, 4.Improbable, 5.Not related, 6.Not evaluable)). Measurement time: up to 15 days of patient follow-up.