N/A N=102 Randomized Treatment

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

Dysmenorrhea

Bottom Line

View on ClinicalTrials.gov: NCT00951561 ↗

Enrolled (actual)

102

Serious AEs

2.0%

Results posted

Oct 2010

Primary outcome: Primary: 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 — 73.8; 75.5 percentage of uses — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Vipon (Device); Ibuprofen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Another Way Products
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	73.8; 75.5	<0.05 sig

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.

Eligibility Criteria

Inclusion Criteria

Females ages >= 18 years
4 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

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 protocol
Allergic to ibuprofen

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00951561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.