A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing
 intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who
 request long-term, reversible contraception for up to 10 years.
This is a Phase 3, randomized, open-label, multicenter evaluation of the efficacy of a
 levonorgestrel-releasing intrauterine system (LNG20). The goals of the study include
 provision of information to understand efficacy and safety within the widest range of
 possible users of the LNG20. Typically, intrauterine contraceptive studies only include women
 18-35 years of age for efficacy and safety, and place limits on parity and larger body size.
 Women outside of these characteristics also desire an effective intrauterine contraceptive.
 Accordingly, this study will include women who are both nulliparous and parous as well as
 women less than 18 years of age in the primary efficacy and safety analyses
Inclusion Criteria:

 -  Healthy women requesting contraception

 -  16-35 years old

 -  Cohort 36-45 years old

 -  Sexually active

 Exclusion Criteria:

 -  Currently pregnant, pregnant within 4 weeks prior to study entry or planning pregnancy
 within 24 months of study entry

 -  Currently breastfeeding

 -  Current persistent, abnormal vaginal bleeding