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NCT00380627 Clinical Trial

Quality of Life With Arcoxia in Women With Dysmenorrhea (0663-094)

Pain Clinical Trial

Official title:
Quality of Life With Arcoxia in Women With Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00380627
Other study ID # 0663-094
Secondary ID 2006_035
Status Completed
Phase Phase 4
First received
Last updated
Start date September 1, 2005
Est. completion date January 31, 2006

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.

Recruitment information / eligibility
Status Completed
Enrollment 337
Est. completion date January 31, 2006
Est. primary completion date January 31, 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Perception of menstrual pain, through the analog verbal scale during three days.
Secondary Quality of life measures during three days.
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