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 toadmission 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 menstrualcramps, 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 injectionsin the last six (06) months;

• Previous diagnosis or physical examination findings and/or clinical and/or surgicalhistory that may indicate the presence of endometriosis, pelvic inflammatorydisease, adenomyosis, mullerian duct malformation, uterine fibroma, cystic ovaryand/or pelvic varicocele;

• History of recurrent pelvic and/or lower abdominal pain outside the menstrualperiod;

• Presence of known allergy or hypersensitivity to the components of the drugs usedduring the clinical trial;

• History of hypersensitivity reactions, such as asthma attacks or other types ofallergic reactions, to acetylsalicylic acid or other NSAIDs;

• History or diagnosis of peptic/hemorrhagic ulcer;

• History of gastrointestinal bleeding or perforation related to the use of NSAIDs;

• Presence of compromised bone marrow function or diseases of the hematopoieticsystem;

• Diagnosis of acute intermittent hepatic porphyria;

• Diagnosis of congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD);

• Diagnosis of untreated angle-closure glaucoma;

• Presence of mechanical stenosis in the gastrointestinal tract;

• Diagnosis of megacolon and/or paralytic or obstructive ileus;

• Diagnosis of myasthenia gravis;

• 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 thelast five (05) years;

• Presence of any serious illness, at the discretion of the investigator;

• Any finding of clinical observation (clinical/physical evaluation) or laboratorycondition that is interpreted by the investigating physician as a risk to theparticipation of the research participant in the clinical trial or presence ofuncontrolled chronic disease(s);

• Participants who are pregnant, nursing or planning to become pregnant;

• Disagreement with the use of a known effective barrier contraceptive method, unlessusing a stable oral contraceptive for three months or more (which must be maintainedthroughout the study), or surgically sterile or who expressly declare themselvesexempt from risk of pregnancy for not exercising sexual practices or exercising themin a non-reproductive manner;

• 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 thatthere may be a direct benefit to it;

• Presence of any condition that, at the discretion of the investigator, makes thepatient unfit to participate in the study.