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| Sponsors and Collaborators: |
Truman Medical Center Another Way Products |
| Information provided by: | Truman Medical Center |
| ClinicalTrials.gov Identifier: | NCT00587782 |
Purpose
To compare pain relief in symptom clusters (abdominal pain, back pain, cramps) between Vipon and ibuprofen.
| Condition | Intervention |
|
Dysmenorrhea |
Device: Vipon Drug: Ibuprofen |
| MedlinePlus related topics: | Menstruation |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen. |
| Estimated Enrollment: | 47 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Vipon tampon
|
Device: Vipon
Vipon tampon
|
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2: Active Comparator
ibuprofen
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Drug: Ibuprofen
Ibuprofen 200 - 400mg per menstrual cycle
|
To compare Quality of Life between treatment with Vipon and ibuprofen. To compare time of pain relief between Vipon tampon and ibuprofen. To assess the safety of the Vipon tampon.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Missouri | |||||
| Truman Medical Center | |||||
| Kansas City, Missouri, United States, 64108 | |||||
| Truman Medical Center |
| Another Way Products |
| Principal Investigator: | Julie L. Strickland, M.D. | Truman Medical Center |
More Information
Truman Medical Center 
  |
University of Missouri-Kansas City 
  |
| Responsible Party: | Another Way Products ( Gerry Eftink ) |
| Study ID Numbers: | 05-96 |
| First Received: | December 21, 2007 |
| Last Updated: | August 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00587782 |
| Health Authority: | United States: Food and Drug Administration |
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