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

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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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The PI agrees not to originate or use the name of Another Way Products, LLC and/or VIPON, or any of its employees, in any publicity, news release or other public announcement, written or oral, whether to the public, press or otherwise, relating to this protocol, to any amendment herto, or to the performance here under, without the prior written consent of Another Way Products, LLC

Limitations and Caveats

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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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

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