NCT00092729

An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)

A Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pain relieving effect and safety of an investigational drug in women with moderate to severe primary dysmenorrhea (painful menstruation).

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	etoricoxib (MK0663)	Two etoricoxib 60 mg tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea
DRUG	Comparator: placebo (unspecified)	Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea
DRUG	Comparator: naproxen sodium	Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea

Timeline

• Start date: 2002-06-07
• Primary completion: 2002-12-06
• Completion: 2002-12-06
• First posted: 2004-09-28
• Last updated: 2024-08-15