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A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
This study has been completed.
Study NCT00951561   Information provided by Another Way Products
First Received: July 31, 2009   Last Updated: October 6, 2009   History of Changes

July 31, 2009
October 6, 2009
November 2006
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00951561 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
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.

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
Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Dysmenorrhea
  • Device: Vipon
  • Drug: Ibuprofen
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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
Gerry Eftink, Another Way Products
AWP01-01
Another Way Products
 
 
Another Way Products
October 2009

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