A Comparison of the Pain Relief From Dysmenorrhea Between Ibuprofen or the Vipon Tampon
Information source: Truman Medical Center
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dysmenorrhea
Intervention: Vipon (Device); Ibuprofen (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Truman Medical Center Official(s) and/or principal investigator(s):
Julie L. Strickland, M.D., Principal Investigator, Affiliation: Truman Medical Center
Overall contact:
Jacki Witt, WHNP, RN, Phone: 816-404-5173, Email: jacki.witt@tmcmed.org
Summary
To compare pain relief in symptom clusters (abdominal pain, back pain, cramps) between Vipon
and ibuprofen.
Clinical Details
Official title: A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen.
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: The primary outcome for the study is pain relief.
Secondary outcome: Quality of Life between the Vipon and ibuprofen, safety evaluation of the Vipon tampon, and time of pain relief between the Vipon and ibuprofen.
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Jacki Witt, WHNP, RN, Phone: 816-404-5173, Email: jacki.witt@tmcmed.org
Truman Medical Center, Kansas City, Missouri 64108, United States; Recruiting
Julie L. Strickland, M.D., Principal Investigator
Additional Information
Truman Medical Center University of Missouri-Kansas City
Starting date: March 2006
Ending date: December 2008
Last updated: February 7, 2008
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