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Type: Artigo de periódico
Title: Comparative Clinical Trial Of The Progestins R-2323 And Levonorgestrel Administered By Subdermal Implants
Author: Alvarez F.
Robertson D.N.
de Oca V.M.
Sivin I.
Brache V.
Faundes A.
Abstract: A random assignment comparative clinical trial of the progestins R-2323 and levonorgestrel delivered by the subdermal implant mode was carried out to assess the relative merits of the two regimens. Six 3-cm polydimethylsiloxane capsules containing the drug were implanted subdermally in the ventral aspect of the forearm of each subject. There were 48 subjects in the group with implants containing R-2323 and 52 subjects in the group with implants containing levonorgestrel. The original design had called for 100 subjects in each group, but enrollments were stopped when elevated serum transaminase levels were reported in Chilean women using the same R-2323 regimen. There were no pregnancies in 504 months of use of the R-2323 and there was one pregnancy in 512 months of use of the levonorgestrel regimen. One year continuation rates were 72.9 for R-2323 and 69.2 for levonorgestrel. Bleeding irregularities were an important reason for discontinuations of the levonorgestrel implants. Prolonged intervals of amenorrhea were common in subjects using R-2323 which was considered to be a beneficial side effect in the population where anemia and poor nutrition are not uncommon. Transaminase levels showed only marginal increases. Although pruritus and acne were more common in subjects using R-2323 than levonorgestrel, androgenic side effects were much less common than reported from Chile and Finland. © 1978.
Rights: fechado
Identifier DOI: 10.1016/0010-7824(78)90090-2
Date Issue: 1978
Appears in Collections:Unicamp - Artigos e Outros Documentos

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