title: A single-arm phase III study exploring the efficacy and safety of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5 mg), in an Asia-Pacific population.
abstract: OBJECTIVE
  The objective was to evaluate the efficacy and safety of a low-dose levonorgestrel intrauterine system with total content 13.5 mg (average approximately 8 μg/24 h over the first year; LNG-IUS 8; Jaydess®) in an Asia-Pacific population.
  
  
  METHODS
  An open-label, single-arm phase III study conducted at 25 centers in China, Australia and Korea assessed LNG-IUS 8 use over 3 years in nulliparous and parous women (N=1114) aged 18-40 years with regular menstrual cycles (21-35 days). Primary outcome was pregnancy rate, expressed as the Pearl Index. Secondary outcomes included 3-year cumulative failure rate, treatment-emergent adverse events (TEAEs), discontinuation rate, bleeding profile and placement pain.
  
  
  RESULTS
  The full analysis set comprised 925 women (mean age 31.6 years, 6.4% nulliparous). Overall unadjusted Pearl Index was 0.35 (95% confidence interval 0.15-0.70); the 3-year cumulative failure rate was 0.9% (95% confidence interval 0.4-1.9). TEAEs and study drug-related TEAEs were reported in 70.1% and 31.2% of women, respectively. Overall, 27.9% of women discontinued the study, 16.9% due to adverse events. Frequent or prolonged bleeding (World Health Organization criteria) decreased from the first to the twelfth 90-day reference intervals (from 5.0% to 0.7% and from 44.1% to 3.0%, respectively), and the percentage of women with amenorrhea increased over time (from 0.4% to 10.8%). Pain on placement was reported as "none" or "mild" in 91.9% of women.
  
  
  CONCLUSIONS
  LNG-IUS 8 was an effective and well-tolerated contraceptive method, providing another option for women in the Asia-Pacific region.
  
  
  CONCLUSIONS
  In this phase III study, LNG-IUS 8 was shown to be highly effective and well tolerated in an Asia-Pacific population and was not associated with any new or unexpected safety events. LNG-IUS 8 provides another contraceptive option for women in the Asia-Pacific region.
authors.affiliation: Peking Union Medical College Hospital, Dongcheng District, Beijing, 100730, China. Electronic address: fgsxiehe@163.com.
authors.forename: Guangsheng
authors.initials: G
authors.lastname: Fan
authors.affiliation: CHA Bundang Women's Medical Center, CHA University, Gyeonggi-do, Republic of Korea. Electronic address: kang@cha.ac.kr.
authors.forename: Sukho
authors.initials: S
authors.lastname: Kang
authors.affiliation: Southeast University-affiliated Zhongda Hospital, Nanjing, China. Electronic address: RenMulan@seu.edu.cn.
authors.forename: Mulan
authors.initials: M
authors.lastname: Ren
authors.affiliation: Family Planning New South Wales, Ashfield, 2131, New South Wales, Australia; University of Sydney, Camperdown, 2006, New South Wales, Australia. Electronic address: edithw@fpnsw.org.au.
authors.forename: Edith
authors.initials: E
authors.lastname: Weisberg
authors.affiliation: Bayer Oy, Espoo, Finland. Electronic address: eeva.lukkari-lax@bayer.com.
authors.forename: Eeva
authors.initials: E
authors.lastname: Lukkari-Lax
authors.affiliation: Bayer Pharma AG, Berlin, Germany. Electronic address: katrin.roth@bayer.com.
authors.forename: Katrin
authors.initials: K
authors.lastname: Roth
authors.affiliation: Bayer HealthCare Pharmaceuticals, Seoul, Republic of Korea. Electronic address: soyoung.shin@bayer.com.
authors.forename: SoYoung
authors.initials: S
authors.lastname: Shin
mesh_terms: D000293:Adolescent; D000328:Adult; D001315:Australia; D002681:China; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D008796:Metrorrhagia / Q000139:chemically induced; D011247:Pregnancy; D018873:Pregnancy Rate; D056910:Republic of Korea; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003271:Contraceptive Agents, Female; D016912:Levonorgestrel
keywords: Asia-Pacific; Contraception; Intrauterine contraception; Intrauterine device; Intrauterine system