Conditions: Contraception
Keywords: Contraception Intrauterine IUD IUS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2885
Healthy volunteers: yes

Brief summary:
This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years

Detailed description:
Drop out-rate will be covered in Participant flow section.

Arms:
arm 1: Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro arm 2: Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro

Interventions: intervention 1: LCS12 intervention 2: LCS16
Intervention descriptions: intervention 1: Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h intervention 2: Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h

Protocol document: