Overview

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

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Another Way Products
Treatments:
Ibuprofen
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