efficacy and safety of deh113 in the treatment of menstrual cramp pain in primary dysmenorrhea: a pilot study

Conditions: Primary Dysmenorrhea

Summary: this study aims to evaluate the preliminary efficacy and safety of deh113 in the treatment of menstrual cramps pain associated with primary dysmenorrhea.


Eligibility criteria:
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;