A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception

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