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

This study is ongoing, but not recruiting participants.

First Received: December 21, 2007 Last Updated: February 3, 2009 History of Changes

Sponsors and Collaborators:	Truman Medical Center Another Way Products
Information provided by:	Truman Medical Center
ClinicalTrials.gov Identifier:	NCT00587782

Purpose

To compare pain relief in symptom clusters (abdominal pain, back pain, cramps) between Vipon and ibuprofen.

Condition	Intervention
Dysmenorrhea	Device: Vipon Drug: Ibuprofen

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/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:

MedlinePlus related topics: Menstruation

Drug Information available for: Ibuprofen Dexibuprofen

U.S. FDA Resources

Further study details as provided by Truman Medical Center:

Primary Outcome Measures:

The primary outcome for the study is pain relief. [ Time Frame: four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life between the Vipon and ibuprofen, safety evaluation of the Vipon tampon, and time of pain relief between the Vipon and ibuprofen. [ Time Frame: Four months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	47
Study Start Date:	March 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Vipon tampon	Device: Vipon Vipon tampon
2: Active Comparator ibuprofen	Drug: Ibuprofen Ibuprofen 200 - 400mg per menstrual cycle

Detailed Description:

To compare Quality of Life between treatment with Vipon and ibuprofen. To compare time of pain relief between Vipon tampon and ibuprofen. To assess the safety of the Vipon tampon.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must have four (4) consecutive monthly menstrual cycles
Self-assessment of dysmenorrhea
Non-pregnant
Adequate birth control during trial
Consent to use tampons through all assessments
Able to use ibuprofen

Exclusion Criteria:

Prohibited use of pain medications 4 hours prior to treatment and during the first 2 hours after treatment with study medication (ibuprofen).
Positive pregnancy test
Unwilling or unable to comply with the study protocol
Allergic to ibuprofen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587782

Locations

United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108

Sponsors and Collaborators

Truman Medical Center

Another Way Products

Investigators

Principal Investigator:

Julie L. Strickland, M.D.

Truman Medical Center

More Information

Additional Information:

Truman Medical Center This link exits the ClinicalTrials.gov site

University of Missouri-Kansas City This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Another Way Products ( Gerry Eftink )
Study ID Numbers:	05-96
Study First Received:	December 21, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00587782 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Truman Medical Center:

Painful Menstruation

Study placed in the following topic categories:

Anti-Inflammatory Agents
Ibuprofen
Cyclooxygenase Inhibitors
Pain
Signs and Symptoms
Oxymetazoline
Pelvic Pain
Dysmenorrhea

Menstruation Disturbances
Phenylephrine
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

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 July 06, 2009