NCT Number: NCT00380627
Quality of Life With Arcoxia in Women With Dysmenorrhea (0663-094)
Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.
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Notify MeKey information
Conditions
Age range
18 year–25 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 4
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Perception of menstrual pain, through the analog verbal scale during three days.
Secondary outcomes
-
Quality of life measures during three days.
Sponsors and collaborators
Lead sponsor
Organon and Co
Industry
Registry information
Official study title
Quality of Life With Arcoxia in Women With Dysmenorrhea
Important dates
- Study start
- 2005
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Sep 26, 2006
- Registry last updated
- Aug 15, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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