71393
document
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 . STUDY DESIGN 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 . CONCLUSION The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women . IMPLICATIONS STATEMENT A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years .
71394
Intervention_Pharmacological
levonorgestrel-releasing
71395
Intervention_Pharmacological
levonorgestrel intrauterine contraceptive ( LNG20 )
71396
Intervention_Pharmacological
LNG20
71397
Intervention_Pharmacological
LNG20
71398
Intervention_Pharmacological
LNG20
71399
Intervention_Pharmacological
LNG20
71400
Intervention_Pharmacological
LNG20
71401
Intervention_Pharmacological
LNG20
71402
Intervention_Pharmacological
LNG20
71403
Intervention_Pharmacological
levonorgestrel-releasing intrauterine system
71404
Participant_Condition
levonorgestrel intrauterine contraceptive ( LNG20 )
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Participant_Sex
women
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Participant_Age
16-45 years
71407
Participant_Sex
Women
71408
Participant_Age
36-45
71409
Participant_Sample-size
1600
71410
Participant_Sex
women
71411
Participant_Age
aged 16-35 years
71412
Participant_Sample-size
151
71413
Participant_Sex
women
71414
Participant_Age
aged 36-45 years
71415
Participant_Sample-size
438
71416
Participant_Sex
women
71417
Participant_Sample-size
1714
71418
Participant_Sex
women
71419
Participant_Sex
women
71420
Participant_Sex
women
71421
Participant_Sex
women