Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes

Headache. 2011 May;51(5):664-73. doi: 10.1111/j.1526-4610.2011.01894.x.


Objective: To evaluate the impact of a sumatriptan/naproxen sodium combination tablet on patient satisfaction, productivity, and functional disability in menstrual migraine treated during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea.

Background: Menstrual migraineurs with dysmenorrhea represent a unique patient population not previously studied. When health outcomes end points are analyzed alongside traditional efficacy end points in migraine studies, a more comprehensive and robust understanding of the many factors that may influence patients' choice of and adherence to pharmacological treatments for migraine is observed.

Methods: In 2 replicate, multicenter, randomized, double-blind, placebo-controlled trials, participants with menstrual migraine and dysmenorrhea treated a single menstrual migraine attack with a single fixed-dose tablet of sumatriptan 85 mg formulated with RT Technology™ and naproxen sodium 500 mg (sumatriptan-naproxen sodium) or placebo.

Results: Participants randomized to sumatriptan-naproxen sodium were significantly more satisfied than those randomized to placebo at 24 hours post dose, as demonstrated by higher satisfaction subscale scores for efficacy (P < .001 for both studies), functionality (P = .003 for study 1; P < .001 for study 2), and ease of use (P = .027 for study 1; P = .011 for study 2). There was little bothersomeness of side effects associated with either treatment. Use of sumatriptan-naproxen sodium was also associated with lower reported "lost-time equivalents" in work and leisure time (pooled analysis, P = .003) and lower rates of functional disability (P = .05, study 1; P < .001, study 2) compared with placebo.

Conclusion: A fixed-dose combination tablet containing sumatriptan and naproxen sodium significantly improved patient satisfaction, productivity, and restoration of normal functioning in menstrual migraineurs with dysmenorrhea.

Trial registration: NCT00329355 NCT00329459.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Analgesics / administration & dosage*
  • Double-Blind Method
  • Drug Combinations
  • Dysmenorrhea / complications
  • Dysmenorrhea / drug therapy*
  • Female
  • Humans
  • Migraine Disorders / drug therapy*
  • Migraine Disorders / etiology
  • Naproxen / administration & dosage*
  • Patient Satisfaction
  • Premenstrual Syndrome / drug therapy*
  • Sumatriptan / administration & dosage*


  • Analgesics
  • Drug Combinations
  • Naproxen
  • Sumatriptan

Associated data