Back to resultsQuality of Life With Arcoxia in Women With Dysmenorrhea (0663-094)
Primary Purpose
Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Perception of menstrual pain, through the analog verbal scale during three days.
Secondary Outcome Measures
Quality of life measures during three days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00380627
Brief Title
Quality of Life With Arcoxia in Women With Dysmenorrhea (0663-094)
Official Title
Quality of Life With Arcoxia in Women With Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2005 (Actual)
Primary Completion Date
January 31, 2006 (Actual)
Study Completion Date
January 31, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
337 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days
Primary Outcome Measure Information:
Title
Perception of menstrual pain, through the analog verbal scale during three days.
Secondary Outcome Measure Information:
Title
Quality of life measures during three days.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Quality of Life With Arcoxia in Women With Dysmenorrhea (0663-094)
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