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

This study is ongoing, but not recruiting participants.

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
Menstruation, Painful
Device: Vipon Tampon
Drug: Ibuprofen and tampon

MedlinePlus related topics:   Menstruation   

ChemIDplus related topics:   Ibuprofen    Dexibuprofen    Phenylephrine    Guaifenesin    Naphazoline    Naphazoline hydrochloride    Oxymetazoline    Oxymetazoline hydrochloride    Phenylephrine hydrochloride    Phenylpropanolamine    Phenylpropanolamine hydrochloride   

U.S. FDA Resources

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

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

Responsible Party:   University of Kansas Medical Center ( John Calkins )
Study ID Numbers:   AWP01-01
First Received:   April 3, 2007
Last Updated:   June 24, 2008
ClinicalTrials.gov Identifier:   NCT00456079
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Naphazoline
Oxymetazoline
Signs and Symptoms
Ibuprofen
Pelvic Pain
Menstruation Disturbances
Dysmenorrhea
Guaifenesin
Phenylephrine
Pain
Phenylpropanolamine

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Pathologic Processes
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 August 29, 2008




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