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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00951561
Recruitment Status : Completed
First Posted : August 4, 2009
Results First Posted : October 4, 2010
Last Update Posted : June 16, 2011
Information provided by:
Another Way Products

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.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Device: Vipon Drug: Ibuprofen Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
Study Start Date : November 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Experimental: Vipon 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.
Other Name: Vipon, vibrating tampon

Active Comparator: Ibuprofen Drug: Ibuprofen
400 mg daily
Other Name: Ibuprofen, NSAIDs

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00951561

United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
University of Kansas Medical Center, Department of Obstetrics and Gynecology
Kansas City, Missouri, United States, 66160
Sponsors and Collaborators
Another Way Products

Responsible Party: Charles Tepper, Director, Another Way Products, LLC Identifier: NCT00951561     History of Changes
Obsolete Identifiers: NCT00456079, NCT00587782
Other Study ID Numbers: AWP01-01
First Posted: August 4, 2009    Key Record Dates
Results First Posted: October 4, 2010
Last Update Posted: June 16, 2011
Last Verified: June 2011

Keywords provided by Another Way Products:

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action