Official Title: “A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen.”

To compare pain relief in symptom clusters (abdominal pain, back pain, cramps) between Vipon and ibuprofen.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

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.

Intervention(s) in this Clinical Trial

• Device: Vipon
  • Vipon tampon
• Drug: Ibuprofen
  • Ibuprofen 200 - 400mg per menstrual cycle

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Vipon tampon
• Active Comparator: 2
  • ibuprofen

Primary Measures

• The primary outcome for the study is pain relief.
  • Time Frame: four months
    Safety Issue?: No

Secondary Measures

• Quality of Life between the Vipon and ibuprofen, safety evaluation of the Vipon tampon, and time of pain relief between the Vipon and ibuprofen.
  • Time Frame: Four months
    Safety Issue?: Yes

Inclusion Criteria:

• Must have four (4) consecutive monthly menstrual cycles
• Self-assessment of dysmenorrhea
• Non-pregnant
• Adequate birth control during trial
• Consent to use tampons through all assessments
• Able to use ibuprofen

Exclusion Criteria:

• Prohibited use of pain medications 4 hours prior to treatment and during the first 2 hours after treatment with study medication (ibuprofen).
• Positive pregnancy test
• Unwilling or unable to comply with the study protocol
• Allergic to ibuprofen

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Truman Medical Center

Overall Clinical Trial Officials and Contacts

Julie L. Strickland, M.D. Principal Investigator Truman Medical Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00587782

Study ID Number: 05-96

ClinicalTrials.gov Identifier: NCT00587782

Health Authority: United States: Food and Drug Administration

Truman Medical Center

University of Missouri-Kansas City