This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception. The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
84
Low dose; treatment duration of 6 months with a possible extension to 12 months
Intermediate dose; treatment duration of 6 months with a possible extension to 12 months
High dose; treatment duration of 6 months with a possible extension to 12 months
The primary efficacy outcome for the trial is insertion and removal characteristics, adverse event reporting and subject's satisfaction with the ENG-MIUS
Time frame: 6 months
Vaginal bleeding pattern
Time frame: Days 92 to 182
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Duration of 6 months with a possible extension to 12 months