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Contraception with two levonorgestrel rod implants. A 5-year study in the United States and Dominican Republic.
Sivin, I; Alvarez, F; Mishell, D R; Darney, P; Wan, L; Brache, V; Lacarra, M; Klaisle, C; Stern, J.
Afiliação
  • Sivin I; Center for Biomedical Research, Population Council, New York, New York 10021, USA.
Contraception ; 58(5): 275-82, 1998 Nov.
Article em En | MEDLINE | ID: mdl-9883382
ABSTRACT
PIP: 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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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Levanogestrel / Anticoncepcionais Femininos Tipo de estudo: Clinical_trials / Etiology_studies Limite: Adolescent / Adult / Female / Humans / Pregnancy País/Região como assunto: America do norte / Caribe ingles / Dominica / Republica dominicana Idioma: En Revista: Contraception Ano de publicação: 1998 Tipo de documento: Article País de afiliação: Estados Unidos País de publicação: Estados Unidos
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Levanogestrel / Anticoncepcionais Femininos Tipo de estudo: Clinical_trials / Etiology_studies Limite: Adolescent / Adult / Female / Humans / Pregnancy País/Região como assunto: America do norte / Caribe ingles / Dominica / Republica dominicana Idioma: En Revista: Contraception Ano de publicação: 1998 Tipo de documento: Article País de afiliação: Estados Unidos País de publicação: Estados Unidos