NCT00649415

A Double Blind, Double Dummy, Randomized, Comparative Study Of The Efficacy And Safety Of Valdecoxib 40 Mg Twice Daily, As Needed In The First Menstrual Cycle Day And Then Once A Day, And Piroxicam 40 Mg Once A Day In The Treatment Of Patients With Primary Dysmenorrhea

A Double Blind, Double Dummy, Randomized, Comparative Study Of The Efficacy And Safety Of Valdecoxib 40 Mg BID, PRN In The First Menstrual Cycle Day And Then Once A Day, And Piroxicam 40 Mg Once A Day In The Treatment Of Patients With Primary Dysmenorrhea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

To compare the analgesic efficacy, safety, and tolerability of valdecoxib versus piroxicam in subjects with moderate to severe menstrual cramping pain associated with primary dysmenorrhea.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	piroxicam	piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle
DRUG	valdecoxib	valdecoxib 40 mg capsule twice a day (BID), taken as required, on the first day of treatment in the menstrual cycle followed by oral valdecoxib 40 mg once a day (QD) for up to the first 3 days of the menstural cycle

Timeline

• Start date: 2003-01-01
• Completion: 2003-07-01
• First posted: 2008-04-01
• Last updated: 2018-12-05

Locations

10 sites across 1 country: Brazil