title: 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.
abstract: 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.
  
  
  METHODS
  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 chi(2)-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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of São Paulo, São Paulo City, Brazil.
authors.forename: Nilson Roberto
authors.initials: NR
authors.lastname: de Mello
authors.forename: Edmund Chada
authors.initials: EC
authors.lastname: Baracat
authors.forename: Geraldez
authors.initials: G
authors.lastname: Tomaz
authors.forename: Aloísio José
authors.initials: AJ
authors.lastname: Bedone
authors.forename: Aroldo
authors.initials: A
authors.lastname: Camargos
authors.forename: Ione Cristina
authors.initials: IC
authors.lastname: Barbosa
authors.forename: Rosival Nassar
authors.initials: RN
authors.lastname: de Souza
authors.forename: Demetrio Ortega
authors.initials: DO
authors.lastname: Rumi
authors.forename: Felix Octavio
authors.initials: FO
authors.lastname: Martinez Alcala
authors.forename: Jorge Antonio Aldrete
authors.initials: JA
authors.lastname: Velasco
authors.forename: Roberto Jose Risco
authors.initials: RJ
authors.lastname: Cortes
mesh_terms: D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D004412:Dysmenorrhea / Q000188:drug therapy*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D008528:Mefenamic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D000077239:Meloxicam; D013843:Thiazines / Q000009:adverse effects / Q000627:therapeutic use*; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D013843:Thiazines; D013844:Thiazoles; D008528:Mefenamic Acid; D000077239:Meloxicam