BACKGROUND This study was conducted to evaluate the therapeutic efficacy of a device designed to deliver high-frequency vibratory stimulation through direct intravaginal tampon application (VIPON) compared with a low-dose over-the-counter pharmacologic treatment of dysmenorrhea. METHODS A randomized, open-label, prospective study comparing the investigational device to an oral self-administration of the over-the-counter dose of 200-400 mg of ibuprofen with the onset of menstrual discomfort was conducted at two academic medical centers in the Midwest region of the United States. Women age 18 and older with self-reported dysmenorrhea were treated with either VIPON or a single dose of 200-400 mg of ibuprofen, randomized for each of the next four menstrual cycles, and pain reduction from baseline was measured according to the Melzack-McGill pain scale. RESULTS Overall, both ibuprofen and VIPON have significant effects on pain reduction according to the Melzack-McGill pain scale. However, the VIPON group achieved statistically significant greater, and more rapid, pain relief at every time point when compared with the ibuprofen. CONCLUSIONS VIPON tampon is a viable, nonpharmacologic option to traditional low-dose over-the-counter pharmacologic therapies for menstrual pain management with more rapid onset of action.