Kristina Gemzell-Danielsson1, Dan Apter2, Eeva Lukkari-Lax3, Katrin Roth4, Marco Serrani4. 1. Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden. Electronic address: Kristina.Gemzell@ki.se. 2. VL-Medi, Helsinki, Finland. 3. Bayer Oy, Espoo, Finland. 4. Bayer AG, Berlin, Germany.
Abstract
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 EvoInserter® placement device. STUDY DESIGN: This was a pooled analysis using data from three previously reported Phase III 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®. 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 EvoInserter® placement device by HCPs. RESULTS: LNG-IUS 8 placement using the modified EvoInserter® 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 EvoInserter®. 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® 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 EvoInserter® may remove some concerns among HCPs about difficult placement of LNG-IUSs, thereby encouraging increased uptake of an effective contraceptive. IMPLICATIONS STATEMENT: Results reported in this study further strengthen evidence of the high placement success rate, ease of deployment, and manageable pain associated with the modified EvoInserter® placement device. These findings might reduce concerns among HCPs about placement of LNG-IUSs, meaning uptake of such contraceptives is increased.
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 EvoInserter® placement device. STUDY DESIGN: This was a pooled analysis using data from three previously reported Phase III 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®. 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 EvoInserter® placement device by HCPs. RESULTS: LNG-IUS 8 placement using the modified EvoInserter® 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 EvoInserter®. 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® 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 EvoInserter® may remove some concerns among HCPs about difficult placement of LNG-IUSs, thereby encouraging increased uptake of an effective contraceptive. IMPLICATIONS STATEMENT: Results reported in this study further strengthen evidence of the high placement success rate, ease of deployment, and manageable pain associated with the modified EvoInserter® placement device. These findings might reduce concerns among HCPs about placement of LNG-IUSs, meaning uptake of such contraceptives is increased.