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A Multicentred Phase III Comparative Study between Single Rod Implant Monoplant® and Double Rod Implant Indoplant® | Biomedgrid

Journal: American Journal of Biomedical Science & Research (Vol.4, No. 6)

Publication Date:

Authors : ; ;

Page : 455-460

Keywords : Single Rod; Implant; Contraception; AJBSR;

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Objective: To analyze to determine the effectiveness, safety, and time of both contraceptive methods between single rod implant monoplant® and double rod implant indoplant®. Design/data identification: Clinical trial, ‘Open' (‘open label ‘Randomized Clinical Trial). Materials and methods: This study is a phase III clinical trial, conducted randomized and multicentre, comparing two types of contraceptive implants, namely Monoplant® and Indoplant® performed in Indonesian healthy women. Random blocks of tithe allocation and randomly assigned divided by 5 Monoplants and 5 Indoplants. Results: Based on the interim results obtained from examining the twenty-fourth month this can be concluded as follows: all centre have completed the number of research subjects, the length of recruitment of subjects extends between 5.5 months to 16.5 months, continuity up to 24 months for contraception implantation of monoplant® or Indoplant® is still good, discontinued use for 24 months totaling 50 subjects, namely 27 subjects for monoplant® and 23 subjects for indoplant®, the main cause of discontinuation for both types of contraception is a disruption of menstrual patterns, there is one case of pregnancy that is most likely due to the initial selection error of the acceptor, there were 7 subjects who had to be removed because they wanted more children even though they had previously agreed to use implants for 3 years, there is no significant difference in levonorgestrel levels in the 24th month between monoplant® contraception and indoplant® contraception, the levonorgestrel levels of the two study groups in the 24th month were mostly located between 200 to 400 picograms which were still actively preventing ovulation. Conclusion: There is no significant difference the effectiveness, safety, and time in levonorgestrel levels in the 24th month between single rod implant monoplant® and double rod implant indoplant®.

Last modified: 2019-10-14 18:27:57