Phase 3 Study Update of LNG-IUS12 and LNG-IUS16 for Prevention of Pregnancy

Bayer HealthCare announced results of a Phase 3 study evaluating two intrauterine systems (IUDs), LNG-IUS12 and LNG-IUS16, for the prevention of pregnancy for up to three years.

The global, randomized, Phase 3, open-label study included 2,884 women aged 18–35 years with regular menstrual cycles (21–35 days) requesting contraception. Study participants were randomized to either LNG-IUS12 (n=1,432), which had an in vitro release rate of 12µg /day, or LNG-IUS16 (n=1,452), a second investigational IUD with an in vitro release rate of 16µg/day. Among those who participated in the study, 39% had never had a child (nulliparous) while the remainder had at least one child (parous).

The Pearl Index (PI) was the primary efficacy endpoint used to assess contraceptive reliability. The PI is based on pregnancies that occurred after the start of treatment and within seven days after IUD removal or expulsion. The unadjusted three-year Pearl Indices (95% CI) were 0.33 for LNG-IUS12 and 0.31 for LNG-IUS16. Cumulative failure rates over three years were 0.9% for LNG-IUS12 and 1% for LNG-IUS16.

LNG-IUS12 and LNG-IUS16 are investigational levonorgestrel-releasing IUDs.

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