A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen

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

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 to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.

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 hours are lost annually to this affliction with an average loss of time of two or more workdays per year per female employee. Treatment of dysmenorrhea may include either non-pharmacological or pharmacological measures. Pharmacological treatments include oral contraceptives to treat hormonal imbalances, over-the-counter analgesics or non-steroidal anti-inflammatory drugs. The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation. This study aims to provide information on the safety and efficacy of the Vipon in a randomized controlled clinical trial.

Intervention(s) in this Clinical Trial

• Device: Vipon
  • The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation, used during menstruation to provide pain relief for women with dysmenorrhea.
• Drug: Ibuprofen
  • 400 mg daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Vipon
• Active Comparator: Ibuprofen

Primary Measures

• Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model
  • Time Frame: 1 month, 2 months, 3 months, 4 months
    Safety Issue?: No

Inclusion Criteria:

• 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 Criteria:

• 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

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?: Accepts Healthy Volunteers

Lead Investigator: Another Way Products Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00951561

Study ID Number: AWP01-01

ClinicalTrials.gov Identifier: NCT00951561

Health Authority: United States: Institutional Review Board