Status:
COMPLETED
Quality of Life With Arcoxia in Women With Dysmenorrhea (0663-094)
Lead Sponsor:
Organon and Co
Conditions:
Pain
Eligibility:
FEMALE
18-25 years
Phase:
PHASE4
Brief Summary
Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.
Eligibility Criteria
Inclusion
- Healthy women older than 18 years old and younger than 25 years old
- Voluntary agreement to participate in the study and signature of informed consent
- Women with clinical diagnosis of dysmenorrhea
Exclusion
- Diagnosis of secondary dysmenorrhea due to: endometriosis, adenomyosis, malformations of Muller's conducts, uterine fibromyomas, ovarian cystic, pelvic varicocoele, inflammatory pelvic disease, adherences, intrauterine devices, cervical channel stenosis, etc.
- Patients with diagnosis of acute inflammatory abdomen
- Patients with diagnosis of congestive heart disease, stroke (1 year), unstable angina, and history of myocardial infarction
- Women auto prescribing rescue medication for dysmenorrheal pain during the study
- Women with a diagnosis of mild dysmenorrhea
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 31 2006
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT00380627
Start Date
September 1 2005
End Date
January 31 2006
Last Update
August 15 2024
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