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Rofecoxib, a specific cyclooxygenase-2 inhibitor, in primary dysmenorrhea: a randomized controlled trial
B W Morrison1, S E Daniels, P Kotey
1Merck Research Labs, Rahway, New Jersey, USA. briggs_morrison@merck.com
Obstetrics and Gynecology
|October 8, 1999
Summary
Rofecoxib effectively treats primary dysmenorrhea pain. Cyclooxygenase-2 derived prostanoids are involved in the condition's pathophysiology, with rofecoxib showing comparable efficacy to naproxen sodium.
Area of Science:
- Pharmacology
- Gastroenterology
- Pain Management
Background:
- Primary dysmenorrhea is a common gynecological condition characterized by painful menstruation.
- The role of cyclooxygenase-2 (COX-2) in the pathophysiology of primary dysmenorrhea requires further elucidation.
Purpose of the Study:
- To evaluate the efficacy of rofecoxib in treating primary dysmenorrhea.
- To investigate the involvement of COX-2 in the underlying mechanisms of primary dysmenorrhea.
Main Methods:
- A double-masked, randomized, placebo- and active-comparator-controlled crossover trial was conducted.
- 127 subjects with primary dysmenorrhea received placebo, rofecoxib (25 or 50 mg), or naproxen sodium (550 mg).
- Analgesic efficacy was assessed via self-administered questionnaires and adverse experiences were monitored.
Main Results:
- Rofecoxib (25 and 50 mg) demonstrated significantly greater analgesic efficacy compared to placebo (P < or = .006).
- Both rofecoxib doses showed efficacy comparable to naproxen sodium across all measured endpoints.
- All treatment regimens were well-tolerated with no significant adverse events reported.
Conclusions:
- Rofecoxib is an effective treatment for primary dysmenorrhea.
- The findings support the role of cyclooxygenase-2-derived prostanoids in the pathophysiology of primary dysmenorrhea.