Double-blind study to evaluate efficacy and safety of meloxicam 7.5 mg and 15 mg versus mefenamic acid 1500 mg in the treatment of primary dysmenorrhea
Article first published online: 28 JUN 2004
Acta Obstetricia et Gynecologica Scandinavica
Volume 83, Issue 7, pages 667–673, July 2004
How to Cite
De Mello, N. R., Baracat, E. C., Tomaz, G., Bedone, A. J., Camargos, A., Barbosa, I. C., De Souza, R. N., Rumi, D. O., Martinez Alcala, F. O., Velasco, J. A. A. and Cortes, R. J. R. (2004), Double-blind study to evaluate efficacy and safety of meloxicam 7.5 mg and 15 mg versus mefenamic acid 1500 mg in the treatment of primary dysmenorrhea. Acta Obstetricia et Gynecologica Scandinavica, 83: 667–673. doi: 10.1111/j.0001-6349.2004.00433.x
- Issue published online: 28 JUN 2004
- Article first published online: 28 JUN 2004
- Submitted 13 May, 2003 Accepted 30 September, 2003
- mefenamic acid;
- primary dysmenorrhea;
- lumbar pain
Objective. Assessment of efficacy and safety of meloxicam 7.5 mg and 15 mg once a day (o.a.d.) compared with mefenamic acid 500 mg three times a day (t.i.d.), over a treatment period of 3–5 days, during three menstrual cycles, for primary dysmenorrhea.
Study design. Multicenter, multinational, double-blind, double-dummy, three parallel groups, randomized trial, phase IIb, 337 patients. Treatment group comparisons of continuous variables were carried out using the Kruskal–Wallis test and Wilcoxon signed rank tests. Efficacy was analyzed using Fisher and χ2-tests.
Results. Meloxicam 7.5 mg and 15 mg showed a similar profile in pain reduction and dysmenorrhea symptoms when compared with mefenamic acid. Thirty-five subjects presented with gastrointestinal (GI) adverse events (AEs). Two-thirds of those 35 subjects were in the mefenamic acid group. There were no differences between the safety profiles of the two meloxicam dosages. Laboratory abnormalities did not differ in incidence among the treatment groups.
Conclusion. Both of the daily doses of meloxicam tested were comparable to 500 mg mefenamic acid t.i.d. in relieving dysmenorrhea symptoms, and meloxicam seems to have a better gastrointestinal tolerability profile.