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
Status and phase
Completed
Phase 4
Conditions
Dysmenorrhea
Treatments
Drug: piroxicam
Drug: valdecoxib
Details and patient eligibility
About
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.
Enrollment
154 patients
Sex
Female
Ages
18 to 44 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
154 participants in 2 patient groups
Arm 1
Active Comparator group
Treatment:
Drug: piroxicam
Arm 2
Active Comparator group
Treatment:
Drug: valdecoxib
Trial contacts and locations
10
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Data sourced from clinicaltrials.gov
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