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
Results First Received: September 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Dysmenorrhea
Interventions: Device: Vipon
Drug: Ibuprofen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vipon/Ibuprofen/Vipon/Ibuprofen Subjects participated for a total of 4 menstrual cycles. Subjects used either VIPON as a medical device or up to 2 ibuprofen tablets (each tablet containing 200 mg ibuprofen) during the first menstrual cycle. Subjects used crossover treatment during second menstrual cycle, randomized for cycle 3, and crossed over for cycle 4. All subjects used tampons for absorption of menstrual fluid during treatment and at least 2 hours post treatment. Subjects taking ibuprofen also used a tampon during treatment.
Ibuprofen/Vipon/Ibuprofen/Vipon No text entered.
Vipon/Ibuprofen/Ibuprofen/Vipon No text entered.
Ibuprofen/Vipon/Vipon/Ibuprofen No text entered.

Participant Flow:   Overall Study
    Vipon/Ibuprofen/Vipon/Ibuprofen     Ibuprofen/Vipon/Ibuprofen/Vipon     Vipon/Ibuprofen/Ibuprofen/Vipon     Ibuprofen/Vipon/Vipon/Ibuprofen  
STARTED     25 [1]   29     21 [2]   27  
COMPLETED     25     29     18 [3]   26 [4]
NOT COMPLETED     0     0     3     1  
[1] Randomized Vipon or Ibuprofen period 1, crossover period 2, randomized period 3, crossover period 4
[2] 1 subject used Vipon periods 1 & 2 instead of Ibuprofen period 2.
[3] 3 subjects dropped after period 2
[4] 1 subject dropped after period 2



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Study Participants 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.

Baseline Measures
    Study Participants  
Number of Participants  
[units: participants]
  102  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     102  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  32.1  ± 8.1  
Gender  
[units: participants]
 
Female     102  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     102  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Charles Tepper
Organization: Another Way Products
phone: 917-538-6894
e-mail: charles_tepper@yahoo.com


No publications provided


Responsible Party: Charles Tepper, Director, Another Way Products, LLC
ClinicalTrials.gov Identifier: NCT00951561     History of Changes
Obsolete Identifiers: NCT00456079, NCT00587782
Other Study ID Numbers: AWP01-01
Study First Received: July 31, 2009
Results First Received: September 30, 2010
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board