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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 31, 2009
Last Updated Date	June 14, 2011
Start Date ^ICMJE	November 2006
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 24, 2010)	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.
Original Primary Outcome Measures ^ICMJE (submitted: August 3, 2009)	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 ]
Change History	Complete list of historical versions of study NCT00951561 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: August 3, 2009)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
Official Title ^ICMJE	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 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 ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Dysmenorrhea
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Vipon Intervention: Device: Vipon Active Comparator: Ibuprofen Intervention: Drug: Ibuprofen
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	115
Completion Date	September 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Female
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00951561
Other Study ID Numbers ^ICMJE	AWP01-01
Has Data Monitoring Committee	No
Responsible Party	Charles Tepper, Director, Another Way Products, LLC
Study Sponsor ^ICMJE	Another Way Products
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Another Way Products
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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