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

Another Way Products

Status: Completed

Conditions: Dysmenorrhea

Treatments: Drug: Ibuprofen; Device: Vipon

Study type: Interventional

Funder types: Industry

Identifiers

NCT00951561

AWP01-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Vipon

Experimental group

Treatment:

Device: Vipon

Ibuprofen

Active Comparator group

Treatment:

Drug: Ibuprofen