Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 mu g and ethinylestradiol 15 mu g (Minesse (R))

Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 mu g and ethinylestradiol 15 mu g (Minesse (R))

Autor Barbosa, I. C. Google Scholar
Isaia, C. Google Scholar
Faggion, D. Google Scholar
Baracat, E. C. Google Scholar
Instituição Universidade Federal da Bahia (UFBA)
Ctr Med Reprod Dr Carlos Isaia Filho
DFJ Clin Med
Universidade Federal de São Paulo (UNIFESP)
Resumo Objective: A prospective, open-label, noncomparative, multicenter study was carried out in 163 women aged 18-39 (mean 25 +/- 5 years), who used an ultra-low-dose oral contraceptive pill (OCP) containing gestodene (GTD) 60 mu g/ethinylestradiol (EE) 15 mu g for 6 months. the objective of the study was to evaluate the acceptability, safety, bleeding patterns and premenstrual symptomatology in these women.Methods: Patients used the OCP from Days 1-24, followed by a 4-day pill-free interval from Days 25-28 of the menstrual cycle. Physical and gynecological examinations were carried out at baseline and after 3 and 6 months, at which time blood pressure, weight, hemoglobin, hematocrit, SGOT, SGPT and urinalysis were also assessed. the Moos Menstrual Distress Questionnaire (MDQ) was completed on three consecutive days (Days 25-27 of the cycle) at baseline and at the end of the third and sixth cycles. Patients kept a menstrual diary throughout the study.Results: A total of 146 women completed the study. Ten women discontinued because of adverse events and one undesired pregnancy occurred during treatment. No adverse metabolic effects were observed. the adverse event most frequently reported was breakthrough bleeding, which diminished, however, as the time of OC use increased. Cycle length and duration of bleeding decreased significantly with OC use (p<.01 and p<.05, respectively, after 6 months). Intensity of menstrual bleeding tended to decrease with OC use, but this difference was not statistically significant. Systolic and diastolic blood pressure were significantly lower after 6 months of OC use compared to baseline (p<.02). No alterations were recorded in body weight or laboratory evaluations. Statistically significant changes were found both in the total MDQ score and in several of the factors evaluated, and patients showed a statistically significant improvement in well-being with respect to premenstrual complaints and symptoms.Conclusion: This OC regimen is safe, well-accepted and well-tolerated, affects menstrual patterns beneficially by reducing both the intensity and duration of bleeding, provides good cycle control and improves premenstrual symptomatology. (C) 2006 Elsevier Inc. All rights reserved.
Palavra-chave contraceptives
moos menstrual distress questionnaire
ethinylestradiol
gestodene
bleeding patterns
Idioma Inglês
Data de publicação 2006-01-01
Publicado em Contraception. New York: Elsevier B.V., v. 73, n. 1, p. 30-33, 2006.
ISSN 0010-7824 (Sherpa/Romeo, fator de impacto)
Publicador Elsevier B.V.
Extensão 30-33
Fonte http://dx.doi.org/10.1016/j.contraception.2005.06.057
Direito de acesso Acesso restrito
Tipo Artigo
Web of Science WOS:000234788600005
Endereço permanente http://repositorio.unifesp.br/handle/11600/28642

Exibir registro completo




Arquivo

Arquivo Tamanho Formato Visualização

Não existem arquivos associados a este item.

Este item está nas seguintes coleções

Buscar


Navegar

Minha conta