Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea

Inclusion Criteria: * Patient has given written informed consent to participate in the study prior to admission to the study; * Female patients aged between 16 and 35 years old, inclusive; * History of regular menstrual cycles, occuring between every 21 to 35 days; * Clinical history compatible with the diagnosis of primary dysmenorrhea; * Self-reported history of ≥ 4 painful cycles, with moderate or severe menstrual cramps, in the six (06) months prior to selection for the study. Exclusion Criteria: * Diagnosis of secondary dysmenorrhea; * History of non-response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to relieve menstrual cramps; * Onset of primary dysmenorrhea after starting to use oral contraceptives; * Use of oral contraceptives for \< 3 months prior to study selection; * Use of an intrauterine device (IUD), hormonal implants or contraceptive injections in the last six (06) months; * Previous diagnosis or physical examination findings and/or clinical and/or surgical history that may indicate the presence of endometriosis, pelvic inflammatory disease, adenomyosis, mullerian duct malformation, uterine fibroma, cystic ovary and/or pelvic varicocele; * History of recurrent pelvic and/or lower abdominal pain outside the menstrual period; * Presence of known allergy or hypersensitivity to the components of the drugs used during the clinical trial; * History of hypersensitivity reactions, such as asthma attacks or other types of allergic reactions, t…