Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
18-44 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- Subjects who were pregnant, lactating, breastfeeding or not using adequate methods of birth control
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00649415
Start Date
January 1 2003
End Date
July 1 2003
Last Update
December 5 2018
Active Locations (10)
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1
Pfizer Investigational Site
Salvador, Estado de Bahia, Brazil
2
Pfizer Investigational Site
Goiânia, Goiás, Brazil
3
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30130-100
4
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30130-110