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Contraception with two levonorgestrel rod implants. A 5-year study in the United States and Dominican Republic.

Authors
  • Sivin, I
  • Alvarez, F
  • Mishell, D R Jr
  • Darney, P
  • Wan, L
  • Brache, V
  • Lacarra, M
  • Klaisle, C
  • Stern, J
Type
Published Article
Journal
Contraception
Publisher
Elsevier
Publication Date
Nov 01, 1998
Volume
58
Issue
5
Pages
275–282
Identifiers
PMID: 9883382
Source
Medline
Keywords
License
Unknown

Abstract

The newly developed 2-rod levonorgestrel (LNG) implant system has a surface area only 44% that of Norplant yet provides LNG release rates and blood levels similar to the 6-capsule Norplant system. Clinical trials of the 2-rod implant system initiated in 1990 demonstrated an exceptionally low cumulative pregnancy rate (0.8/100) in the first 3 years of use. This paper reports on an extension of the original study for an additional 2 years. 594 women at 4 study sites in the US and the Dominican Republic completed 5 years of method use. No pregnancies occurred in the fourth and fifth years of use. Thus, the 5-year cumulative pregnancy rate was 0.8/100, with an average annual pregnancy rate below 2/1000 women. The mean annual continuation rate during the 5-year study period was 77/100 women, with an average duration of use of 2.96 years. The most frequent reasons for medical removal were prolonged bleeding/spotting (8.2% of women), irregular bleeding (5.6%), headache (4.7%), and weight gain (4.0%). Mean removal time was 5.9 minutes and complications occurred in only 2.3% of removals. Overall, these findings confirm that the 2-rod LNG implant contraceptive has an effectiveness equivalent to the 6-capsule implant for a 5-year period, with good acceptability and a substantially improved ease of removal.

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