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

Dysmenorrhea Clinical Trial

Official title:

A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951561
• Other study ID #: AWP01-01
• Status: Completed
• Phase: N/A
• First received: July 31, 2009
• Last updated: June 14, 2011
• Start date: November 2006
• Est. completion date: September 2009

Study information

• Verified date: June 2011
• Source: Another Way Products
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00456079
• NCT00587782

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

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.

Drug:
• Ibuprofen
400 mg daily

Locations

Country	Name	City	State
United States	Truman Medical Center	Kansas City	Missouri
United States	University of Kansas Medical Center, Department of Obstetrics and Gynecology	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Another Way Products

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	1 month, 2 months, 3 months, 4 months	No