avaliação da tolerabilidade e do controle de ciclo de dois contraceptivos orais de baixa dose: estudo comparativo aberto assessment of the tolerability and cycle control of two low-dose oral contraceptives: an open-label study

Clicks: 328
ID: 230628
1998
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Abstract
Realizou-se um estudo aberto comparativo em nove centros brasileiros para avaliar a tolerabilidade e o controle de ciclo obtido com o uso de dois contraceptivos orais de baixa dose contendo 20 mg etinilestradiol/75 mg gestodeno e 20 mg etinilestradiol/150 mg desogestrel, durante seis ciclos de tratamento. Foram selecionadas 167 mulheres saudáveis com vida sexual ativa (77 no grupo do gestodeno e 90 no grupo do desogestrel), das quais 138 completaram os seis ciclos de tratamento. Em um subgrupo de novas usuárias realizou-se também perfil lipídico e hemostático. Foram avaliados 867 ciclos no total. Ocorreu sangramento irregular em 4,6% dos ciclos com gestodeno e em 8,1% com desogestrel. A tolerabilidade a ambas preparações foi boa, mas houve significativamente mais náusea no grupo do desogestrel. O controle de ciclo foi bom com os dois contraceptivos, sendo que houve freqüência significativamente menor de sangramento irregular no grupo do gestodeno quando se leva em conta que todos os ciclos foram considerados. Não houve alterações clinicamente significativas no perfil hemostático. O perfil lipídico mostrou tendência a tornar-se mais favorável após seis ciclos de tratamento com as duas preparações. Não ocorreu alteração no peso médio das mulheres no grupo do gestodeno; no grupo do desogestrel houve aumento significativo no peso médio de aproximadamente 1 kg após seis meses de tratamento. A adesão ao tratamento foi boa com as duas preparações. Os resultados deste estudo mostram que preparações contendo baixa dose de gestodeno ou desogestrel associados a 20 mg de etinilestradiol são contraceptivos bem tolerados que permitem bom controle de ciclo, sem efeitos colaterais significantes.
An open-label comparative study was conducted in nine centers in Brazil to evaluate the tolerability and cycle control of two low-dose oral contraceptives containing 20 mg ethynylestradiol/75 mg gestodene and 20 mg ethynylestradiol/150 mg desogestrel, during six treatment cycles. A total of 167 healthy sexually active women were enrolled (77 in the gestodene group and 90 in the desogestrel group) and 138 completed the six-cycle treatment period. A lipid and hemostatic profile was performed for a subgroup of first users. A total of 867 cycles were evaluated. Irregular bleeding did not occur in 95.4% of the cycles evaluated with gestodene and in 91.9% with desogestrel. Tolerability was good with both preparations but there was significantly more nausea in the desogestrel group. Cycle control was good with both preparations with a significantly lower incidence of irregular bleeding with gestodene when all cycles were considered. There were no clinically significant changes in the hemostatic profile. Lipid profile showed a trend to be more favorable after six cycles of treatment with both preparations. Women in the gestodene group did not present changes in the mean weight; in the desogestrel group there was a significant mean weight increase of 1 kg after six cycles of treatment. Compliance with treatment was good with both preparations. Results of this study demonstrated that low-dose preparations containing gestodene or desogestrel combined with 20 mg of ethynylestradiol are well-tolerated oral contraceptives that provide good cycle control.
Reference Key
baracat1998revistaavaliao Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors ;Edmund C. Baracat;Ione C. Barbosa;Altamiro A. Campos;Sylvia B. Hyppolito;Nilson R. de Melo;Rafael Mussielo;Rosival Nassar;João S. Pinho-Neto;Geraldez Tomaz
Journal 2018 international conference on information technologies, infotech 2018 - proceedings
Year 1998
DOI
10.1590/S0100-72031998000500007
URL
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-72031998000500007
Keywords
coagulation contraception estrogen progesterone cycle control

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