Back to resultsA Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vipon
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea focused on measuring Dysmenorrhea
Eligibility Criteria
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
Sites / Locations
- Truman Medical Center
- University of Kansas Medical Center, Department of Obstetrics and Gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vipon
Ibuprofen
Arm Description
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00951561
Brief Title
A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
Official Title
A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Another Way Products
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vipon
Arm Type
Experimental
Arm Title
Ibuprofen
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Vipon
Other Intervention Name(s)
Vipon, vibrating tampon
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Ibuprofen, NSAIDs
Intervention Description
400 mg daily
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
1 month, 2 months, 3 months, 4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
University of Kansas Medical Center, Department of Obstetrics and Gynecology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
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