Status:
COMPLETED
A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
Lead Sponsor:
Another Way Products
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject was randomized t...
Detailed Description
Pain caused by dysmenorrhea can range from mild to severe. At least 50% of all menstruating women experience appreciable pain at some time during their menstruation. An estimated 600 million work hour...
Eligibility Criteria
Inclusion
- Females ages \>= 18 years
- 4 consecutive monthly menstrual cycles
- Self-assessment of dysmenorrhea
- Non-pregnant status
- Agrees to use adequate birth control during the trial
- Consents to use tampons through the test of cure assessment
- Provides informed consent for participating in the trial
Exclusion
- Prohibited use of pain medication 4 hours prior to treatment and during the first 2 hours after treatment with study medication
- Positive pregnancy test
- Unwilling or unable to comply with protocol
- Allergic to ibuprofen
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00951561
Start Date
November 1 2006
End Date
September 1 2009
Last Update
June 16 2011
Active Locations (2)
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1
Truman Medical Center
Kansas City, Missouri, United States, 64108
2
University of Kansas Medical Center, Department of Obstetrics and Gynecology
Kansas City, Missouri, United States, 66160