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

• adverse events [ Time Frame: approximately 5 days after treated cycle ] [ Designated as safety issue: Yes ]
• laboratory analyses [ Time Frame: screening ] [ Designated as safety issue: Yes ]
• Subjects' global evaluation of the study drug [ Time Frame: 8 hours and 72 hours ] [ Designated as safety issue: No ]
• Summed pain intensity difference [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
• Percent of subjects who took rescue medication [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
• Percent of subjects who took the second dose of study medication [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

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.

• 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

• Active Comparator: Arm 1
  Intervention: Drug: piroxicam
• Active Comparator: Arm 2
  Intervention: Drug: valdecoxib

Inclusion Criteria:

• History of primary dysmenorrhea with moderate to severe menstrual cramping pain for which the patient took analgesic medication for at least three of six previous menstrual cycles before enrollment
• Subjects were to have been in good health and were to have had a complete physical exam (including a pap smear and an endovaginal or pelvic ultrasound, unless the subject had had these examinations performed within 6 months prior to the Screening Visit and the results were normal) prior to inclusion

Exclusion Criteria:

• Subjects who were pregnant, lactating, breastfeeding or not using adequate methods of birth control