Device could effectively alleviate menstrual cramp pain
“The aim of our study was to find a better way to treat menstrual cramps,” said Giovanni M. Pauletti, Ph.D., associate professor at the University of Cincinnati and study presenter and president after the AAPS National Biotechnology Conference Planning Committee. “Existing oral drugs cause significant gastrointestinal side effects for women, creating additional discomfort while alleviating menstrual pain. The results of our Phase I clinical trials show that this new vaginal delivery device safely, at least 10 times more drug in the womb as a tablet of equivalent dose.
The study, sponsored by UMD, Inc., a drug delivery company in Cincinnati, and held in the Women’s Health Research, Inc. involving 18 study participants, aged 18-45 years with menstrual cycles between 25-30 days. During the follicular phase average of first menstrual cycle (days 7-11), nine study participants received an oral dose of 10 mg of ketorolac (Toradol ®), a non-steroidal anti-inflammatory drug, while nine women received a coated tampon 10 mg of ketorolac. During the second menstrual cycle, each subject received the opposite treatment.
The study results showed that vaginally administered medication does not cause significant side effects, but accumulates more efficiently in the uterine tissue is desired that the use of oral medication.
“While still early in our research, this study shows promising results that can help pave the way for new treatment options for women,” said Pauletti. “Clinical trials phase II study the efficacy of treatment to determine if the concentration of the drug is effective in reducing pain.”
Source: American Association of Pharmaceutical Scientists