Medicines360 and Allergan Announce Study Publication Evaluating Pelvic Infection Risk Following Same-Day Sexually Transmitted Infection Testing and LILETTA (levonorgestrel-releasing intrauterine system) 52 mg Placement
Published 14 November 2016
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 (A Comprehensive 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 / ACCESS
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.
Important Safety Information
(scroll to see additional Important Safety Information and full Prescribing Information link)
Who is not appropriate for LILETTA
Use of LILETTA is contraindicated in women with: known or suspected pregnancy and cannot be used for post-coital contraception; congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity; known or suspected breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; acute liver disease or liver tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (e.g., bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in the past 3 months; unexplained uterine bleeding; current IUS; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of LILETTA.
Clinical considerations for use and removal of LILETTA
Use LILETTA with caution after careful assessment in patients with coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removing the intrauterine system if these or the following arise during use: uterine or cervical malignancy or jaundice. Because irregular bleeding/spotting is common during the first months of LILETTA use, exclude endometrial pathology (polyps or cancer) prior to the insertion of LILETTA in women with persistent or uncharacteristic bleeding. If the threads are not visible or are significantly shortened, they may have broken or retracted into the cervical canal or uterus. If LILETTA is displaced (e.g., expelled or perforated the uterus), remove it.
Pregnancy related risks with LILETTA
If pregnancy should occur with LILETTA in place, remove the intrauterine system because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal or manipulation may result in pregnancy loss. Evaluate women for ectopic pregnancy because the likelihood of a pregnancy being ectopic is increased with LILETTA. Tell women about the signs of ectopic pregnancy and associated risks, including loss of fertility. Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection carry a higher risk of ectopic pregnancy.
Educate her about PID
Insertion of LILETTA is contraindicated in the presence of known or suspected PID or endometritis or a history of PID unless there has been a subsequent intrauterine pregnancy. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. About 1/3 of women diagnosed with PID developed the infection within a week of LILETTA insertion, while the remainder were diagnosed more than six months after insertion. Counsel women who receive LILETTA to notify a healthcare provider if they have complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, or genital lesions or sores. PID is often associated with sexually transmitted infections (STIs); LILETTA does not protect against STIs, including HIV. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae. Inform women about the possibility of PID and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death.
Expect changes in bleeding patterns with LILETTA
Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. Cycles may remain irregular, become infrequent, or even cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation.
If a significant change in bleeding develops during prolonged use, take appropriate diagnostic measures to rule out endometrial pathology.
Be aware of other serious complications and most common adverse reactions
Some serious complications with IUSs like LILETTA are sepsis, perforation, and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of other LNG-releasing IUSs. Aseptic technique during insertion of LILETTA is essential in order to minimize serious infections such as GAS.
Perforation (total or partial, including penetration/embedment of LILETTA in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy. If perforation occurs, locate and remove LILETTA. Surgery may be required. Delayed detection or removal of LILETTA in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. The risk of perforation is higher if inserted in lactating women and may be higher if inserted in women who are postpartum or when the uterus is fixed retroverted.
Partial or complete expulsion of LILETTA may occur, resulting in the loss of contraceptive protection.
Delay LILETTA insertion a minimum of 6 weeks or until uterine involution is complete following a delivery or a second trimester abortion. Remove a partially expelled LILETTA. If expulsion has occurred, a new LILETTA may be inserted within 7 days after the onset of a menstrual period after pregnancy has been ruled out.
Ovarian cysts may occur and are generally asymptomatic, but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent ovarian cysts.
In the clinical trial of LILETTA the most common adverse reactions (≥5% users) were vaginal infections (13.6%), vulvovaginal infections (13.3%), acne (12.3%), headache or migraine (9.8%), nausea or vomiting (7.9%), dyspareunia (7.0%), abdominal pain or discomfort (6.8%), breast tenderness or pain (6.7%), pelvic discomfort or pain (6.1%), depression or depressed mood (5.4%), and mood changes (5.2%).
Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion of LILETTA and then yearly or more often if clinically indicated.
Please see the link to LILETTA Full Prescribing Information:
About Allergan Women’s Healthcare
Allergan is a leader in women’s health care that is dedicated to developing and commercializing best-in-class pharmaceuticals to improve the health and wellness of women. Allergan takes a holistic and a best-in-class approach to women’s healthcare as it prioritizes educational partnerships with OB/GYNs. The mission of Allergan Women’s Healthcare extends beyond its pharmaceutical products to ensure that all women can make informed decisions about their health and have access to high-quality medications. Allergan is committed to investing in programs that support the education and well-being of all women.
Medicines360, located in San Francisco, California, is a nonprofit global women's health pharmaceutical company with a mission to expand access to quality medicines for all women regardless of their socioeconomic status, insurance coverage or geographic location. Medicines360 is committed to working with healthcare providers, advocacy groups and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 15,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live healthier lives everyday.
For more information, visit Allergan's website at www.Allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.