The purpose of this study if to evaluate the efficacy and safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.
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;
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 < 4 months prior to study selection;
Crossover
DEH113
DrugTablets
Placebo Comparator
DrugTablets
Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose
Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose. Pain relief will be evaluate using a Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).
Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose
Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose. Pain relief will be evaluate using a Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).
Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose.
Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose. The pain intensity will be assessed using a Categorical 4-point scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain).
Use of rescue medication
Proportion of participants who used rescue medication in the first 24 hours after the first drug intake, amount of rescue medication used in the first 24 hours after the first drug intake, and time elapsed between the last drug intake and the first administration of rescue medication.
Number of additional drug intake
Number of additional drug intake during the 24 hours after the first drug intake
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