There could be a long line of women waiting for this new way to treat menstrual pain and cramps that can often interfere with everyday activities. Results of a Phase I clinical trial show that tampons treated with a nonsteroidal anti-inflammatory drug is more effective than oral medication.
Many women experience some menstrual cramping and pain as part of their monthly menstrual cycle, and the symptoms may or may not require some mild anti-inflammatory or pain relief medications. Other women have dysmenorrhea, or painful menstruation, that disrupts their daily activities and can cause them to lose time at work, school, or at home. Painful uterine cramping may be accompanied by pain in the abdomen or back, along with nausea, vomiting, diarrhea, headache, weakness, or fainting.
The purpose of the recent trial, the results of which will be presented at the 2009 American Association of Pharmaceutical Scientists Annual Meeting and Exposition in November, was to determine if a new approach to treatment of severe menstrual pain and cramping could be effective. Because oral medications for menstrual pain are associated with significant gastrointestinal adverse effects, the investigators turned to a vaginal delivery system.
The study included 18 women ages 18 to 45 years who experienced menstrual cycles between 25 and 30 days. During days 7 through 11, nine of the women received an oral dose of 10 mg of ketorolac (Toradol®), a nonsteroidal anti-inflammatory medication that is prescribed for moderate to severe pain. The other nine women received a tampon coated with 10 mg of ketorolac. During the subsequent menstrual cycle, each of the women received the opposite treatment.
The results showed that the medication delivered via the tampon not only did not cause significant side effects but it also provided at least ten times more drug to the uterine tissue than the same dose of the oral form. This indicates that a vaginal treatment approach for menstrual pain and cramping may be both more effective and safer than oral dosing.
Since this was only a Phase I trial, women with menstrual pain and cramping should not be lining up at their pharmacies just yet. The promising results from this study, however, pave the way for Phase II clinical trials, which will assess whether the vaginal delivery approach and drug concentration can effectively reduce menstrual pain.
American Association of Pharmaceutical Scientists news release September 21, 2009
Mayo Clinic website
Written by Deborah Mitchell
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