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

Tracking Information
First Received Date ^ICMJE	July 31, 2009
Last Updated Date	October 6, 2009
Start Date ^ICMJE	November 2006
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current 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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00951561 on ClinicalTrials.gov Archive Site
Current 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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current

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.
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 Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Condition ^ICMJE	Dysmenorrhea
Intervention ^ICMJE	Device: Vipon Drug: Ibuprofen
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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 ID ^ICMJE	NCT00951561
Responsible Party	Gerry Eftink, Another Way Products
Study ID Numbers ^ICMJE	AWP01-01
Study Sponsor ^ICMJE	Another Way Products
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Another Way Products
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP