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
- Registration Number
- NCT00649415
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 154
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 2 valdecoxib - Arm 1 piroxicam -
- Primary Outcome Measures
Name Time Method Total pain relief were calculated as the summed weighted pain releif scores 8 hours
- Secondary Outcome Measures
Name Time Method adverse events approximately 5 days after treated cycle Subjects' global evaluation of the study drug 8 hours and 72 hours Summed pain intensity difference 8 hours laboratory analyses screening Percent of subjects who took rescue medication 72 hours Percent of subjects who took the second dose of study medication 72 hours
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇷São Paulo, Brazil