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

Purpose

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

Condition	Intervention
Dysmenorrhea	Device: Vipon Drug: Ibuprofen

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 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:	December 2008
Estimated Primary Completion Date:	December 2008 (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

Truman Medical Center This link exits the ClinicalTrials.gov site

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

Responsible Party:	Another Way Products ( Gerry Eftink )
Study ID Numbers:	05-96
First Received:	December 21, 2007
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00587782
Health Authority:	United States: Food and Drug Administration

Keywords provided by Truman Medical Center:

Painful Menstruation

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

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