Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system

ACCESS IUS Investigators

Research output: Contribution to journalArticle

44 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)10-16
Number of pages7
JournalContraception
Volume92
Issue number1
DOIs
StatePublished - Jul 1 2015

Fingerprint

Levonorgestrel
Safety
Pregnancy Rate
Pelvic Infection
Pregnancy
Life Tables
Menstrual Cycle
Contraceptive Agents
Contraception

Keywords

  • Contraception
  • Intrauterine device
  • Levonorgestrel
  • Liletta

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. / ACCESS IUS Investigators.

In: Contraception, Vol. 92, No. 1, 01.07.2015, p. 10-16.

Research output: Contribution to journalArticle

ACCESS IUS Investigators. / Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. In: Contraception. 2015 ; Vol. 92, No. 1. pp. 10-16.
@article{bce1a0ea23764a979e7c118e66b5ed61,
title = "Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system",
abstract = "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.",
keywords = "Contraception, Intrauterine device, Levonorgestrel, Liletta",
author = "{ACCESS IUS Investigators} and Eisenberg, {David L.} and Schreiber, {Courtney A.} and Turok, {David K.} and Teal, {Stephanie B.} and Westhoff, {Carolyn L.} and Creinin, {Mitchell D}",
year = "2015",
month = "7",
day = "1",
doi = "10.1016/j.contraception.2015.04.006",
language = "English (US)",
volume = "92",
pages = "10--16",
journal = "Contraception",
issn = "0010-7824",
publisher = "Elsevier USA",
number = "1",

}

TY - JOUR

T1 - Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system

AU - ACCESS IUS Investigators

AU - Eisenberg, David L.

AU - Schreiber, Courtney A.

AU - Turok, David K.

AU - Teal, Stephanie B.

AU - Westhoff, Carolyn L.

AU - Creinin, Mitchell D

PY - 2015/7/1

Y1 - 2015/7/1

N2 - 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.

AB - 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.

KW - Contraception

KW - Intrauterine device

KW - Levonorgestrel

KW - Liletta

UR - http://www.scopus.com/inward/record.url?scp=84932196777&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84932196777&partnerID=8YFLogxK

U2 - 10.1016/j.contraception.2015.04.006

DO - 10.1016/j.contraception.2015.04.006

M3 - Article

C2 - 25934164

AN - SCOPUS:84932196777

VL - 92

SP - 10

EP - 16

JO - Contraception

JF - Contraception

SN - 0010-7824

IS - 1

ER -