LCS12 vs. ENG Subdermal Implant (Nexplanon) Discontinuation Rate Study

Phase 3 Completed 766 enrolled Bayer

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2011-09
Primary completion: 2013-06
Completion: 2015-04

Publications

Apter D, Briggs P, Tuppurainen M, Grunert J, Lukkari-Lax E, Rybowski S, Gemzell-Danielsson K. A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant. Fertil Steril. 2016 Jul;106(1):151-157.e5. doi: 10.1016/j.fertnstert.2016.02.036. Epub 2016 Mar 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonorgestrel	Small molecule	13.5 mg	Other
Comparator	etonorgestrel	Unknown	68 mg	—

Indications

No indication recorded.