5 years effective! Intrauterine device announced large-scale clinical trial data
May 03, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, at the annual meeting of the American College of Obstetrics and Gynecology (ACOG), Medicines360 and Allergan jointly announced the intrauterine contraceptive system (IUS) LILETTA® (levonorgestrel-releasing intrauterine system, releasing levonorgestrel in the United States). Intrauterine birth control system) 5-year data from 52mg multicenter critical clinical trials.
The study, entitled "Five-Year Effectiveness and Safety of the LILETTA® Levonorgestrel Intrauterine System," was led by Dr. Thomas D. Kimble of the Virginia Medical College. The study provided a five-year pregnancy rate (through the Pearl Index and Life Table analysis) and the safety results of ongoing research.
LILETTA® is a sterile, levonorgestrel-releasing reversible intrauterine contraceptive system with an efficiency of over 99%. The device does not contain estrogen, and it has fewer menstrual periods, shorter menstrual periods, and reduced dysmenorrhea compared to older copper-containing reversible intrauterine contraceptive systems. LILETTA® is currently approved by the FDA for the prevention of pregnancy for up to 4 years. If you need to continue using it, the system should be replaced after 4 years.
The clinical subjects were women in the 16 to 45 age group in the United States, but only the safety of IUS was studied in women aged 36-45. The study collected data from a variety of women, from teens to forties, obesity and non-obesity, and women who had not given birth or gave birth. Among women aged 16-35, the first year's Pearl Index (the number of years of pregnancy per 100 women, defined as 13 menstrual cycles per year) was 0.15 (CI: 0.02, 0.55), 5 years at the time of the study. The cumulative life table (expected probability) pregnancy rate was 0.92 (CI: 0.46, 1.84).
In terms of side effects, two (0.1%) women were perforated after placing the contraceptive, which was found in the first year; 63 (3.7%) subjects had device detachment, and most (50, 79.4%) occurred in In the first year of use; 11 (0.6%) women were diagnosed with pelvic infections. 39 (2.3%) of women who have used it for more than 5 years have stopped bleeding.
â–² Dr. Jessica Grossman (Source: Medicines360 official website)
Dr. Jessica Grossman, CEO of Medicines360, said: "We are encouraged by ACOG's report today, which has been used to submit an application to FDA to extend LILETTA's use time to five years. (If approved) This will further help us achieve The mission of providing long-term reversible contraception to women of all economic levels."
The FDA has accepted the LILETTA® Supplemental New Drug Application (sNDA) in February, and we expect this test result to help the FDA approve faster extensions of the system and further reduce the price of this contraceptive method, making it even more Rapid spread to a wider female population of childbearing age.
Reference materials:
[1] Medicines360 and Allergan Present 5-Year Trial Data from Largest On-going IUS Clinical Study
[2] Liletta official website
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