A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea

Summary

The purpose of this study is to compare the maximum single dose of Aleve® (two tablets, equivalent to 440 mg of naproxen sodium) to the maximum single dose of Tylenol Extra Strength (two caplets, equivalent to 1000 mg of acetaminophen) in the treatment of menstrual pain associated with primary dysmenorrhea.

Timeline

Start

2018-04-05

Primary completion

2018-09-05

Completion

2018-09-05

Outcome

Met primary endpoint

registry analysis (superiority test); Naproxen Sodium vs Acetaminophen; p < 0.001; LS Means Difference 4.31 (95% CI 2.06 to 6.56); ANCOVA NCT03448536 ↗

Publications

• Daniels SE, Paredes-Diaz A, An R, Centofanti R, Tajaddini A. Significant, long-lasting pain relief in primary dysmenorrhea with low-dose naproxen sodium compared with acetaminophen: a double-blind, randomized, single-dose, crossover study. Curr Med Res Opin. 2019 Dec;35(12):2139-2147. doi: 10.1080/03007995.2019.1654987. Epub 2019 Aug 28.

Drugs

Indications