A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen - Full Text View

Sponsor:	Another Way Products
Information provided by:	Another Way Products
ClinicalTrials.gov Identifier:	NCT00951561

Purpose

The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea.

Condition	Intervention
Dysmenorrhea	Device: Vipon Drug: Ibuprofen

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen

Resource links provided by NLM:

Drug Information available for: Ibuprofen

U.S. FDA Resources

Further study details as provided by Another Way Products:

Primary Outcome Measures:

The primary objective of this study is to compare the efficacy of the Vipon with ibuprofen in relieving pain in women with dysmenorrhea. [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare pain relief in symptom clusters between Vipon and ibuprofen [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: No ]
To compare Quality of Life between treatment with the Vipon and ibuprofen [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: No ]
To compare the time of pain relief between the Vipon and ibuprofen [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: No ]
To assess the safety of the Vipon [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: Yes ]

Enrollment:	115
Study Start Date:	November 2006
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vipon: Experimental	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.
Ibuprofen: Active Comparator	Drug: Ibuprofen 400 mg daily

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951561

Locations

United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
University of Kansas Medical Center, Department of Obstetrics and Gynecology
Kansas City, Missouri, United States, 66160

Sponsors and Collaborators

Another Way Products

More Information

No publications provided

Responsible Party:	Another Way Products ( Gerry Eftink )
Study ID Numbers:	AWP01-01
Study First Received:	July 31, 2009
Last Updated:	October 6, 2009
ClinicalTrials.gov Identifier:	NCT00951561 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Another Way Products:

Dysmenorrhea

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ibuprofen
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Pelvic Pain

Dysmenorrhea
Menstruation Disturbances
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010