Five-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52-mg Intrauterine System.

ABSTRACT:

Objective

To assess the 5-year contraceptive efficacy and safety of a levonorgestrel (LNG) 52-mg intrauterine system (IUS) from an ongoing 10-year phase 3 contraceptive trial.

Methods

Study investigators enrolled 1,751 nulliparous and parous females aged 16-45 years and desiring contraception to receive a novel LNG 52-mg IUS at 29 centers in the United States, including reproductive health clinics, private offices, and university centers. Participants had scheduled follow-up visits four times during the first year. After year 1, study visits occurred every 6 months, with phone contact at the 3-month point between visits. We assessed the primary outcome of pregnancy rate (Pearl Index) in females aged 16-35 years at enrollment through 60 months. The safety evaluation included

SUBMITTER: Teal SB 

PROVIDER: S-EPMC6319579 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature