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

Quality of Life With Arcoxia in Women With Dysmenorrhea

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days

• Study Type: Interventional
• Enrollment: 337
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Perception of menstrual pain, through the analog verbal scale during three days.

Secondary Outcome Measures

Outcome Measure
Quality of life measures during three days.

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2005
• Primary Completion (Actual): January 31, 2006
• Study Completion (Actual): January 31, 2006

Study Registration Dates

• First Submitted: September 22, 2006
• First Submitted That Met QC Criteria: September 22, 2006
• First Posted (Estimate): September 26, 2006

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib
• Other Study ID Numbers: 0663-094; 2006_035

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis