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

Sponsors and Collaborators:	University of Kansas Another Way Products
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00456079

Purpose

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

Hypothesis: What is the efficacy of the Vipon tampon when compared with ibuprofen in the relief of pain in women with dysmenorrhea?

Condition	Intervention	Phase
Menstruation, Painful	Device: Vipon Tampon Drug: Ibuprofen and tampon	Phase III

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 University of Kansas:

Primary Outcome Measures:

pain relief using the modified Melzack-MeGill numerical pain scale questionnaire [ Time Frame: pretreatment, 15 min, 30 min, 1 hr, 2 hrs, and 8 hrs after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The MOS-SF36 Quality of Life Questionnaire will be used pre-dose and eight hours after treatment. [ Time Frame: Predose and eight hours after treatment ] [ Designated as safety issue: No ]
Safety [ Time Frame: visits 1, 2 and 3 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	51
Study Start Date:	December 2006
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Vipon tampon	Device: Vipon Tampon Vipon tampon alternating cycles
2: Active Comparator Ibuprofen, tampon	Drug: Ibuprofen and tampon Ibuprofen and tampon alternating cycles

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:	Yes

Criteria

Inclusion Criteria:

Must have four (4) consecutive monthly menstrual cycles
Self-assessment of dysmenorrhea
Non-pregnant
Agrees to use adequate birth control during trial
Consents to use tampons through the test of cure assessment
Must be able to use ibuprofen

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 the protocol
Allergic to ibuprofen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456079

Locations

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

Sponsors and Collaborators

University of Kansas

Another Way Products

Investigators

Principal Investigator:

John W. Calkins, M.D.

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center ( John Calkins )
Study ID Numbers:	AWP01-01
Study First Received:	April 3, 2007
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00456079 History of Changes
Health Authority:	United States: Food and Drug Administration

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