Journal de gynecologie, obstetrique et biologie de la reproduction · 2006
[Acceptability of intrauterine levonorgestrel delivery system (Mirena 52mg) after estrogen-progesterone oral contraception: results of a prospective multicentric study of 211 patients aged 25-35 years].
Клиническое исследование IV фазыАннотация на английскомСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Collinet P, Nayama M, Cosson M
Аннотация
INTRODUCTION: Use of an intrauterine levonorgestrel (SIU-LNG) delivery system (Mirena 52mg has become popular in recent years, particularly among younger women. Mirena is currently the contraceptive method of choice used as an alternative to classical copper-containing intrauterine devices after oral contraception. The purpose of this study was to evaluate patient satisfaction among young women during the first year of use of the intrauterine hormonal system.
MATERIAL AND METHODS: This multicentric phase IV trial with a non-comparative methodology was conducted among 211 young women aged 25-35 years. The SIU-LNG was prescribed for women who wanted to change their contraception after oral estrogen progesterone taken for at least three months prior to inclusion in the study. A total of 211 patients were included and review was planned at one year: 197 patients (93.36%) were reviewed.
RESULTS: Mean patient age was 31.48+/-3.25 years. The SIU-LNG was inserted successfully at the first attempt in 99.05% of women. The continuation rate ws 85.65% at one year. Evaluation of cycle characteristics showed less voluminous blood loss and fewer dysmenorrheal phenomena as well as, in 40%, the development of amenorrhea. At the last visit, 85% of women were satisfied or very satisfied with this method of contraception.
CONCLUSION: As has been demonstrated in earlier studies, Mirena offers a contraception with a reliability equivalent to that of oral estrogen progesterone (IP: 0 - 0.2), with very few hormonal side effects due to the low plasma passage of levonorgestrel. Mirena is particularly well adapted for young women who desire a reliable long-term easty-to-use contraception after taking oral contraception.
MATERIAL AND METHODS: This multicentric phase IV trial with a non-comparative methodology was conducted among 211 young women aged 25-35 years. The SIU-LNG was prescribed for women who wanted to change their contraception after oral estrogen progesterone taken for at least three months prior to inclusion in the study. A total of 211 patients were included and review was planned at one year: 197 patients (93.36%) were reviewed.
RESULTS: Mean patient age was 31.48+/-3.25 years. The SIU-LNG was inserted successfully at the first attempt in 99.05% of women. The continuation rate ws 85.65% at one year. Evaluation of cycle characteristics showed less voluminous blood loss and fewer dysmenorrheal phenomena as well as, in 40%, the development of amenorrhea. At the last visit, 85% of women were satisfied or very satisfied with this method of contraception.
CONCLUSION: As has been demonstrated in earlier studies, Mirena offers a contraception with a reliability equivalent to that of oral estrogen progesterone (IP: 0 - 0.2), with very few hormonal side effects due to the low plasma passage of levonorgestrel. Mirena is particularly well adapted for young women who desire a reliable long-term easty-to-use contraception after taking oral contraception.