To access the efficacy and safety of Meloxicam 7.5 mg and 15 mg once daily compared with Mefenamic acid 500 mg t.i.d. over a treatment period of 3-5 days, during an observation period of 3 menstrual cycles, for the symptomatic relief of primary dysmenorrhea
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
337
Evaluation of severity of lumbar and/or abdominal pain on a visual analogue scale (VAS)
Time frame: Baseline and day 3-5 of each treatment cycle
Final global assessment of efficacy by patient on a 4-point scale
Time frame: day 3-5 of the second treatment cycle
Final global assessment of efficacy by investigator on a 4-point scale
Time frame: day 3-5 of the second treatment cycle
Final global assessment of tolerability by patient on a 4-point scale
Time frame: day 3-5 of the second treatment cycle
Final global assessment of tolerability by investigator on a 4-point scale
Time frame: day 3-5 of the second treatment cycle
Number of Participants with Adverse Events (AE)
Time frame: Up to 4 weeks after last treatment cycle
Incidence of significant laboratory events
Time frame: Up to 4 weeks after last treatment cycle
Number of perforations, ulcerations and/or bleedings (PUB) of the upper gastro-intestinal tract
Time frame: Up to 4 weeks after last treatment cycle
Number of gastro-intestinal adverse events (GI-AEs)
Time frame: Up to 4 weeks after last treatment cycle
Duration of hospitalization stay due to GI-AEs
Time frame: Up to 4 weeks after last treatment cycle
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Number of additional visits at physician due to GI-AEs
Time frame: Up to 4 weeks after last treatment cycle
Duration of hospitalization due to drug related AEs
Time frame: Up to 4 weeks after last treatment cycle
Number of withdrawals due to AEs
Time frame: Up to 4 weeks after last treatment cycle
Intensity of AEs on a 3-point scale
Time frame: Up to 4 weeks after last treatment cycle
Evaluation of labor and/or daily life disability associated with dysmenorrhea on a VAS
Time frame: Baseline and day 3-5 of each treatment cycle
Change in severity of symptomatology associated with dysmenorrhea
Time frame: Baseline and day 3-5 of each treatment cycle