Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system.
OBJECTIVE
To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive (LNG20) designed for up to 7 years use.


METHODS
Nulliparous and parous women aged 16-45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label, partially randomized trial to evaluate LNG20. The primary outcome was pregnancy rate for women aged 16-35 years calculated as the Pearl Index. Women aged 36-45 years received LNG20 for safety evaluation only. All participants had in-person or phone follow-up approximately every 3 months during the study.


RESULTS
A total of 1600 women aged 16-35 years and 151 women aged 36-45 years agreed to LNG20 placement, including 1011 (57.7%) nulliparous and 438 (25.1%) obese women. Successful placement occurred in 1714 (97.9%) women. Six pregnancies occurred, four of which were ectopic. The Pearl Index for LNG20 was 0.15 (95% CI 0.02-0.55) through Year 1, 0.26 (95% CI 0.10-0.57) through Year 2, and 0.22 (95% CI 0.08-0.49) through Year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI 0.24-1.23) through 3 years. Expulsion was reported in 62 (3.5%) participants, most (50 [80.6%]) during the first year of use. Of women who discontinued LNG20 and desired pregnancy, 86.8% conceived spontaneously within 12 months. Pelvic infection was diagnosed in 10 (0.6%) women. Only 26 (1.5%) LNG20 users discontinued due to bleeding complaints.


CONCLUSIONS
The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women.


CONCLUSIONS
A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years.
Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
David L
DL
Eisenberg
Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Courtney A
CA
Schreiber
Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, USA.
David K
DK
Turok
Department of Obstetrics and Gynecology, University of Colorado, Aurora, CO, USA.
Stephanie B
SB
Teal
Department of Obstetrics and Gynecology and Department of Epidemiology, Columbia University, New York, NY, USA.
Carolyn L
CL
Westhoff
Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA. Electronic address: mitchell.creinin@ucdmc.ucdavis.edu.
Mitchell D
MD
Creinin
D000293:Adolescent; D000328:Adult; D003267:Contraception / Q000379:methods*; D003271:Contraceptive Agents, Female / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007433:Intrauterine Device Expulsion; D007436:Intrauterine Devices, Medicated / Q000009:adverse effects*; D016912:Levonorgestrel / Q000008:administration & dosage*; D008875:Middle Aged; D010298:Parity; D034161:Pelvic Infection / Q000453:epidemiology / Q000209:etiology; D011247:Pregnancy; D018873:Pregnancy Rate; D013997:Time Factors; D014592:Uterine Hemorrhage / Q000453:epidemiology / Q000209:etiology; D055815:Young Adult
D003271:Contraceptive Agents, Female; D016912:Levonorgestrel
Contraception; Intrauterine device; Levonorgestrel; Liletta