Dysmenorrhea Clinical Trial
Official title:
A Double Blind, Double Dummy, Randomized, Comparative Study Of The Efficacy And Safety Of Valdecoxib 40 Mg BID, PRN 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
Verified date | December 2018 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 154 |
Est. completion date | July 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Pfizer Investigational Site | Belo Horizonte | Minas Gerais |
Brazil | Pfizer Investigational Site | Belo Horizonte | Minas Gerais |
Brazil | Pfizer Investigational Site | Goiania | Goias |
Brazil | Pfizer Investigational Site | Porto Alegre | RS |
Brazil | Pfizer Investigational Site | Porto Alegre | Rio Grande Do Sul |
Brazil | Pfizer Investigational Site | Rio De Janeiro | RJ |
Brazil | Pfizer Investigational Site | Salvador | Bahia |
Brazil | Pfizer Investigational Site | Sao Paulo | |
Brazil | Pfizer Investigational Site | São Paulo | |
Brazil | Pfizer Investigational Site | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total pain relief were calculated as the summed weighted pain releif scores | 8 hours | ||
Secondary | adverse events | approximately 5 days after treated cycle | ||
Secondary | laboratory analyses | screening | ||
Secondary | Subjects' global evaluation of the study drug | 8 hours and 72 hours | ||
Secondary | Summed pain intensity difference | 8 hours | ||
Secondary | Percent of subjects who took rescue medication | 72 hours | ||
Secondary | Percent of subjects who took the second dose of study medication | 72 hours |
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