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| Sponsors and Collaborators: |
University of Kansas Another Way Products |
|---|---|
| Information provided by: | University of Kansas |
| ClinicalTrials.gov Identifier: | NCT00456079 |
Purpose
To compare pain relief in symptom clusters (abdominal pain, back pain, cramps) between Vipon and ibuprofen.
Hypothesis: What is the efficacy of the Vipon tampon when compared with ibuprofen in the relief of pain in women with dysmenorrhea?
| Condition | Intervention | Phase |
|---|---|---|
|
Menstruation, Painful |
Device: Vipon Tampon Drug: Ibuprofen and tampon |
Phase III |
| 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: | 51 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Vipon tampon
|
Device: Vipon Tampon
Vipon tampon alternating cycles
|
|
2: Active Comparator
Ibuprofen, tampon
|
Drug: Ibuprofen and tampon
Ibuprofen and tampon alternating cycles
|
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: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Kansas | |
| University of Kansas Medical Center, Department of Obstetrics and Gynecology | |
| Kansas City, Kansas, United States, 66160 | |
| Principal Investigator: | John W. Calkins, M.D. | University of Kansas |
More Information
| Responsible Party: | University of Kansas Medical Center ( John Calkins ) |
| Study ID Numbers: | AWP01-01 |
| Study First Received: | April 3, 2007 |
| Last Updated: | September 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00456079 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Inflammatory Agents Ibuprofen Cyclooxygenase Inhibitors Pain Signs and Symptoms Oxymetazoline Pelvic Pain Dysmenorrhea |
Menstruation Disturbances Phenylephrine Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents |
|
Anti-Inflammatory Agents Ibuprofen Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pain Pharmacologic Actions Signs and Symptoms Pathologic Processes Pelvic Pain |
Dysmenorrhea Menstruation Disturbances Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |