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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Another Way Products

Current Primary Outcome: 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 ]

Modified Melzack-McGill Scale measures general pain (0=none, 1-3=mild, 4-6=moderate, 7-9=severe, 10=worst pain) Total Number of Uses Analyzed is a sum of the Number of Uses collected at each time point.


Original Primary Outcome: The primary objective of this study is to compare the efficacy of the Vipon with ibuprofen in relieving pain in women with dysmenorrhea. [ Time Frame: 1 month, 2 months, 3 months, 4 months ]

Current Secondary Outcome:

Original Secondary Outcome:

  • To compare pain relief in symptom clusters between Vipon and ibuprofen [ Time Frame: 1 month, 2 months, 3 months, 4 months ]
  • To compare Quality of Life between treatment with the Vipon and ibuprofen [ Time Frame: 1 month, 2 months, 3 months, 4 months ]
  • To compare the time of pain relief between the Vipon and ibuprofen [ Time Frame: 1 month, 2 months, 3 months, 4 months ]
  • To assess the safety of the Vipon [ Time Frame: 1 month, 2 months, 3 months, 4 months ]


Information By: Another Way Products

Dates:
Date Received: July 31, 2009
Date Started: November 2006
Date Completion:
Last Updated: June 14, 2011
Last Verified: June 2011