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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Truman Medical Center, Kansas City, Missouri, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vipon

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.

Other names: Vipon, vibrating tampon

Ibuprofen

Drug

400 mg daily

Other names: Ibuprofen, NSAIDs

Primary outcomes

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

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.

Sponsors and collaborators

Lead sponsor

Another Way Products

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Aug 4, 2009
Registry last updated: Jun 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed