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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vipon

Group Type EXPERIMENTAL

Vipon

Intervention Type DEVICE

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.

Ibuprofen

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

400 mg daily

Interventions

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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.

Intervention Type DEVICE

Ibuprofen

400 mg daily

Intervention Type DRUG

Other Intervention Names

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Vipon, vibrating tampon Ibuprofen, NSAIDs

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes