Overcoming barriers to levonorgestrel-releasing intrauterine system placement: an evaluation of placement of LNG-IUS 8 using the modified Evolnserter® in a majority nulliparous population

Objectives: To report placement success rate, and ease and pain associated with placement, of the levonorgestrel-releasing intrauterine system (LNG-IUS) 8 using the modified Evolnserter (R) placement device. Study design: This was a pooled analysis using data from three previously reported Phase HI studies in nulliparous (83.3%) or parous (16.7%) women aged 12-35 years (N=965). LNG-IUS 8 was placed using the modified Evolnserter (R). The main outcomes assessed were placement success, ease of placement as reported by healthcare professionals (HCPs), pain at placement as reported by participants, and assessment of the Evolnserter placement device by HCPs. Results: LNG-IUS 8 placement using the modified Evolnserter (R) with an insertion tube diameter of 3.8 mm was successful in 99.5% of subjects. HCPs rated the placement procedure as "easy" in 91.6% of cases. Placement pain was reported as absent by 19.1% of participants, as mild by 39.3%, as moderate by 31.6%, and as severe by 10.0%. Overall 89.2% of HCPs completely agreed that the device was easy to prepare and 85.7% completely agreed that placement of an LNG-IUS was easy/simple with the Evolnserter (R). Post hoc exploratory analyses indicated a significant association between ease/pain of placement and patient age and between pain of placement and parity. Conclusions: The modified Evolnserter (R) was associated with a high placement success rate, ease of placement, and manageable pain, and was assessed to have a user-friendly design. These findings suggest that the Evolnserter (R) may remove some concerns among HCPs about difficult placement of LNG-IUSs, thereby encouraging increased uptake of an effective contraceptive. (C) 2017 The Authors. Published by Elsevier Inc.