LCS12 vs. ENG subdermal implant (Nexplanon) discontinuation rate study

• Research type

  Research Study

• Full title

  Multicenter, open-label, randomized, controlled parallel-group study to assess discontinuation rates, bleeding patterns, user satisfaction and adverse event profile of LCS12 in comparison to etonogestrel subdermal implant over 12 months of use in women 18 to 35 years of age

• IRAS ID

  74965

• Contact name

  Paula Briggs

• Sponsor organisation

  Bayer Health Care AG

• Eudract number

  2010-023911-32

• Research summary

  The primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant over a period of 12 months.Secondary objectives are to observe the bleeding patterns, adverse event profiles and the occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions and implant site complications will be collected.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0511

• Date of REC Opinion

  4 Oct 2011

• REC opinion

  Further Information Favourable Opinion