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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:


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:
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