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

NCT00951561 | Completed Results

• 1 other identifier: AWP01-01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.

Conditions

Dysmenorrhea

Keywords

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model

  Modified Melzack-McGill Scale measures general pain (0=none, 1-3=mild, 4-6=moderate, 7-9=severe, 10=worst pain) Total Number of Uses Analyzed is a sum of the Number of Uses collected at each time point.

  1 month, 2 months, 3 months, 4 months

Study Arms (2)

Vipon

EXPERIMENTAL

Device: Vipon

Ibuprofen

ACTIVE COMPARATOR

Drug: Ibuprofen

Interventions

Vipon DEVICE

The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation, used during menstruation to provide pain relief for women with dysmenorrhea.

Also known as: Vipon, vibrating tampon

Vipon

Ibuprofen DRUG

400 mg daily

Also known as: Ibuprofen, NSAIDs

Ibuprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females ages \>= 18 years
• consecutive monthly menstrual cycles
• Self-assessment of dysmenorrhea
• Non-pregnant status
• Agrees to use adequate birth control during the trial
• Consents to use tampons through the test of cure assessment
• Provides informed consent for participating in the trial

You may not qualify if:

• 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 protocol
• Allergic to ibuprofen

Sponsors & Collaborators

• Another Way Products: lead

Study Sites (2)

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

University of Kansas Medical Center, Department of Obstetrics and Gynecology

Kansas City, Missouri, 66160, United States

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Results Point of Contact

• Title: Charles Tepper
• Organization: Another Way Products

charles_tepper@yahoo.com

917-538-6894

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 4, 2009
• Study Start: November 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 16, 2011
• Results First Posted: October 4, 2010

Record last verified: 2011-06

Locations

US (2)