SAN FRANCISCO and DUBLIN, Nov. 16, 2016 /PRNewswire/ -- Medicines360, a nonprofit global women's health pharmaceutical company, and Allergan, plc (NYSE: AGN), a leading global pharmaceutical company, today announced the publication of, "A prospective assessment of pelvic infection risk following same-day sexually transmitted infection testing and levonorgestrel intrauterine system placement" in the November, 2016 medical journal, American Journal of Obstetrics & Gynecology.
The study evaluated the relationship of chlamydia and gonorrhea screening to pelvic infection for up to 2 years following placement of the LILETTA levonorgestrel intrauterine system (IUS) 52 mg during the ACCESS IUS ( AComprehensive Contraceptive Efficacy and Safety Study of an IUS) clinical trial (study ongoing for 7 years). According to the study, women without clinical evidence of active pelvic infection can have IUS placement and sexually transmitted infection (STI) screening, if indicated, on the same day without increasing pelvic infection risk. Pelvic infection occurred in 9 (0.5%) of the 1,751 women over 2 years after placement. However, 6 out of the 9 infections (66.7%) occurred after day 30, suggesting that pelvic infection is not more common shortly after IUS placement. Concern about the potential for pelvic infection may cause many providers to make women wait for STI screening results before IUS placement, often requiring two or more office visits to receive an IUS. "These additional office visits act as a key access barrier women face when choosing an intrauterine device (IUD). The study findings suggest providers may choose to insert an IUD the same day without waiting for STD testing results," said Dr. Jessica Grossman, CEO of Medicines360. "Reducing barriers like this one is core to our mission at Medicines360, where we are focused on increasing access to birth control and decreasing rates of unintended pregnancy in the U.S., including among low-income women where the rates are disproportionately high." "The study results reinforce existing American Congress of Obstetricians and Gynecologists and Center for Disease Control guidelines that recommend the placement of LARCs (Long-Acting Reversible Contraceptives), like an IUD, in a single visit, and further shows this is a safe practice. 1 STI testing can occur on the same day as LARC placement if there are no signs of active infection," said Dr. David Turok, first author of the study and Associate Professor in the University of Utah's Department of Obstetrics and Gynecology. About the Study / ACCESSAbout LILETTA LILETTA is a hormone-releasing system placed in a woman's uterus to prevent pregnancy. It is greater than 99 percent effective for up to three years as supported by the largest ever IUS trial conducted solely in the U.S. LILETTA has been approved by the FDA for contraception in the U.S. for 3 years based on the initial results of the ACCESS IUS trial. LILETTA is not permanent, it is reversible; it can be removed at any time by a healthcare provider, offering the flexibility of use for either long- or short-term contraception.