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

Phase 4

Completed

• Conditions: Pain

• Registration Number: NCT00380627
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-01
• Primary Completion: 2006-01-31
• Study Completion: 2006-01-31
• Study First Submitted: 2006-09-22
• Study First Submitted QC: 2006-09-22
• Study First Posted: 2006-09-26
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 337

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Perception of menstrual pain, through the analog verbal scale during three days.

Secondary Outcome Measures

Name	Time	Method
Quality of life measures during three days.