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

This study has been completed.
Sponsor:
Information provided by:
Another Way Products
ClinicalTrials.gov Identifier:
NCT00951561
First received: July 31, 2009
Last updated: June 14, 2011
Last verified: June 2011

July 31, 2009
June 14, 2011
November 2006
September 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00951561 on ClinicalTrials.gov Archive Site
Not Provided
  • To compare pain relief in symptom clusters between Vipon and ibuprofen [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: No ]
  • To compare Quality of Life between treatment with the Vipon and ibuprofen [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: No ]
  • To compare the time of pain relief between the Vipon and ibuprofen [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: No ]
  • To assess the safety of the Vipon [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Dysmenorrhea
  • 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
  • Drug: Ibuprofen
    400 mg daily
    Other Name: Ibuprofen, NSAIDs
  • Experimental: Vipon
    Intervention: Device: Vipon
  • Active Comparator: Ibuprofen
    Intervention: Drug: Ibuprofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00951561
AWP01-01
No
Charles Tepper, Director, Another Way Products, LLC
Another Way Products
Not Provided
Not Provided
Another Way Products
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP