Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain in Primary Dysmenorrhea: a Pilot Study

Inclusion Criteria: * Patient has given written informed consent to participate in the study before admission to the study; * Female patients aged between 16 and 35 years old, inclusive; * History of regular menstrual cycles, occurring 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, to acetylsalicylic acid or other NSAIDs; * Previous diagnosis of glaucoma; * Previous diagnosis of kidney and/or liver failure; * Presence of blood dyscrasias and situations of bone marrow suppression; * Diagnosis of acute intermittent hepatic porphyria; * Diagnosis of congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD); * Previous diagnosis of acute intermittent hepatic porphyria; * Presence of mechanical stenosis in the gastrointestinal tract; * Previous diagnosis of paralytic ileus or intestinal atony * Diagnosis of myasthenia gravis; * Previous diagnosis of severe ulcerative colitis or toxic megacolon complicated with ulcerative colitis * Treatment with psychoactive drugs (such as for example, antidepressants, antipsychotics, etc.) in the 30 days prior to selection for the study; * Participants with a history of alcohol or illicit drug use disorder in the last two (02) years; * Participants with a current medical history of cancer and/or cancer treatment in the last five (05) years; * Any finding of clinical observation (clinical/physical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or the presence of uncontrolled chronic disease(s); * Participants who are pregnant, nursing, or planning to become pregnant; * Participation in a clinical research protocol in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit to it;