Abstract
ObjectiveTwo low-dose levonorgestrel intrauterine contraceptive systems (LNG-IUSs; total content 13.5 mg [average approx. 8 μg/24 hours over the first year; LNG-IUS 8] and total content 19.5 mg [average approx. 13 μg/24 hours over the first year; LNG-IUS 13]) have previously been shown to be highly effective (3-year Pearl Indices: 0.33 and 0.31, respectively), safe and well tolerated. The present subgroup analyses evaluated whether or not outcomes were affected by parity, age (18–25 vs 26–35 years), or body mass index (BMI, <30 vs ≥30 kg/m2).MethodsNulliparous and parous women aged 18‒35 years with regular menstrual cycles (21‒35 days) requesting contraception were randomized to 3 years of LNG-IUS 8 or LNG-IUS 13 use.ResultsIn the LNG-IUS 8 and LNG-IUS 13 groups, 1432 and 1452 women, respectively, had a placement attempted and were included in the full analysis set; 39.2%, 39.2% and 17.1% were 18–25 years old, nulliparous and had a BMI ≥30 kg/m2, respectively. Both systems were similarly effective regardless of age, parity or BMI; the subgroup Pearl Indices had widely overlapping 95% confidence intervals. Placement of LNG-IUS 8 and LNG-IUS 13 was easier (p < 0.0001) and less painful (p < 0.0001) in women who had delivered vaginally than in women who had not. The complete/partial expulsion rate was 2.2–4.2% across all age and parity subgroups and higher in parous than in nulliparous women (p = 0.004). The incidence of pelvic inflammatory disease was 0.1–0.6% across all age and parity subgroups: nulliparous and younger women were not at higher risk than parous and older women, respectively. The ectopic pregnancy rate was 0.3–0.4% across all age and parity subgroups. Across all age and parity subgroups, the 3-year completion rate was 50.9–61.3% for LNG-IUS 8 and 57.9–61.1% for LNG-IUS 13, and was higher (p = 0.0001) among older than younger women in the LNG-IUS 8 group only.ConclusionsLNG-IUS 8 and LNG-IUS 13 were highly effective, safe and well tolerated regardless of age or parity.Trial RegistrationClinical trials.gov NCT00528112
Highlights
Two Low-Dose LNG-IUSs: Analyses by Parity and Age was involved in the design of the study and verified the data included in the manuscript, Thomas Schmelter was the study statistician and Sarah Rybowski verified the data included in the manuscript
National and international guidance supports the use of intrauterine contraception (IUC) in a wide range of women, regardless of age and parity [1,2,3,4], IUC is used less frequently in younger and nulliparous women
Over up to 3 years of LNG-IUS 8 or LNG-IUS 13 use, nulliparous women were at no higher risk of pelvic inflammatory disease (PID) than their parous counterparts and younger women aged 18–25 years were no more likely to be diagnosed with PID than older women aged 26–35 years (Table 5)
Summary
National and international guidance supports the use of intrauterine contraception (IUC) in a wide range of women, regardless of age and parity [1,2,3,4], IUC is used less frequently in younger and nulliparous women. Bayer HealthCare has developed two low-dose levonorgestrel intrauterine contraceptive systems (LNG-IUSs); total content 13.5 mg 8 μg/24 hours over the first year; hereafter referred to as LNG-IUS 8) and total content 19.5 mg Compared with LNG-IUS total content 52 mg In a Phase II study, LNG-IUS 8 and LNG-IUS 13 demonstrated good contraceptive efficacy over 3 years with no apparent dose–response, were well tolerated and were significantly easier and less painful to place compared with placement of LNG-IUS 20 using the 4.75 mm diameter placement tube [6]. Based on the results of these two studies, LNG-IUS 8 was approved by the US Food and Drug Administration (as Skyla) for up to 3 years of contraceptive use. LNG-IUS 8 was deemed ‘approvable’ by the Decentralized Procedure in the EU and was subsequently approved (as Jaydess) in most European countries, Canada and some countries in Latin America [8,9]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
