Dysmenorrhea
Conditions
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.
Interventions
DRUGpiroxicam
piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle
DRUGvaldecoxib
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
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pain relief were calculated as the summed weighted pain releif scores | 8 hours |
Secondary
| Measure | Time frame |
|---|---|
| Summed pain intensity difference | 8 hours |
| Percent of subjects who took rescue medication | 72 hours |
| Subjects' global evaluation of the study drug | 8 hours and 72 hours |
| laboratory analyses | screening |
| Percent of subjects who took the second dose of study medication | 72 hours |
| adverse events | approximately 5 days after treated cycle |
Countries
Brazil
Outcome results
None listed