Autoimmune progesterone dermatitis: A case report

Abstract Introduction Autoimmune progesterone dermatitis (APD) is a rare autoimmune dermatosis characterized by recurrent cutaneous and mucosal lesions during the luteal phase of the menstrual cycle that disappear some days after the menses. Case Report A 34-year-old primipara woman with no significant past medical history and no prior exogenous hormone use, who presented with cyclic skin eruptions starting 1 year after the delivery. The lesions occurred 6 days before the menses and disappeared in between 1 and 2 days after the menstruation ceased. The patient was diagnosed after a positive response to an intradermal test with progesterone and was successfully treated with combined oral contraceptives. The skin eruptions have not returned since the initiation of this therapy. Conclusion Dermatologists, gynecologists, and obstetricians should be aware of this rare entity. Furthermore, if this condition is suspected, a thorough history taking on the menstrual cycle and results of the intradermal progesterone test are mandatory.

Experiencia en el tratamiento de la hemorragia uterina anormal en adolescentes con enfermedad renal crónica / Experience in the treatment of uterine hemorrhage in adolescents with chronic renal disease

Resumen: Introducción: La enfermedad renal crónica (ERC) se asocia con alteraciones menstruales, y el manejo del sangrado uterino suele ser complejo por las condiciones de este grupo de pacientes. El objetivo de este trabajo fue describir la respuesta clínica al tratamiento hormonal de las alteraciones menstruales de adolescentes con ERC. Métodos: Se presentan los datos de una serie de casos de pacientes adolescentes con ERC que cursaron con alteraciones menstruales y que recibieron tratamiento desde el año 2008 al 2012. Se identificaron las características del trastorno menstrual, del tratamiento hormonal recibido y de la respuesta al mismo. El análisis estadístico fue descriptivo. Resultados: Se estudiaron 11 pacientes de sexo femenino con edad promedio de 14.5 años, que se encontraban en prediálisis (n = 1), diálisis peritoneal (n = 7) y hemodiálisis (n = 3). Las pacientes presentaron hiperpolimenorrea asociada a la opsomenorrea (n = 3), en su mayoría clasificadas como hemorragia uterina anormal secundaria. El tratamiento, en general, fue con progestágenos de manera inicial (clormadinona con o sin medroxiprogesterona) o bien con anticonceptivos combinados. En la mayoría de las pacientes se obtuvo una respuesta favorable; sin embargo, hubo casos en los que fue necesario modificar la dosis y el tiempo de tratamiento. Conclusiones: La mayor parte de las adolescentes con ERC que han sido tratadas por hemorragia uterina anormal en nuestro estudio tuvieron una respuesta favorable al tratamiento hormonal.

Abstract: Background: Chronic kidney disease (CKD) is associated with menstrual abnormalities and management of uterine bleeding is often complex because of the conditions in this group of patients. The aim of this study was to describe the clinical response to hormonal treatment of menstrual alterations in adolescents with CKD. Methods: We present data of cases of adolescent patients with CKD who had undergone menstrual changes and received treatment during the period 2008 to 2012. The characteristics of the menstrual disorder, hormone treatment received, and response to treatment were evaluated. The statistical analysis aplicated to analyze the results was descriptive. Results: We studied 11 patients with a mean age of 14.5 years, who were in predialysis (n = 1), peritoneal dialysis (n = 7), hemodialysis (n = 3). Patients had hyperpolymenorrhea associated with opsomenorrhea (n = 3), mostly classified as secondary abnormal uterine bleeding. Treatment, in general, was with progestins initially (chlormadinone with or without medroxyprogesterone) or combined contraceptives. In the majority of the patients, a favorable response was obtained; however, there were cases where it was necessary to modify the dose and time of treatment. Conclusions: The majority of adolescents with CKD who have been treated for abnormal uterine bleeding in our study had a favorable response to hormonal treatment.

Patrón de sangrado uterino en adolescentes usuarias de implante anticonceptivo subdérmico de etonogestrel / Uterine bleeding patterns of adolescents using the long term etonogestrel contraceptive implant

Objetivo: Describir las características del patrón sangrado uterino de las adolescentes que usan el implante anticonceptivo sudérmico de etonogestrel (IASE) que concurren a un centro especializado en salud sexual y reproductiva de adolescentes en Santiago, Chile, y su asociación con variables biopsicosocial. Método: Estudio de cohorte retrospectiva de las usuarias de IASE. Los datos fueron analizados utilizando la ecuación de estimación generalizada, análisis de sobrevida de Kaplan Meier y test de log-rank. Resultados: La cohorte incluyó a 62 adolescentes. La media de edad fue de 16,2 años. Las participantes recibieron asesoramiento anticonceptivo antes de la inserción del IASE, y fueron seguidas durante tres años. Los patrones de sangrado más frecuentes durante el primer año fue el de amenorrea (40,5%) y el sangrado aceptable (27,1%), mientras que el menos frecuente fue prolongado y/o sangrado frecuente (15,8%). De acuerdo con el análisis de sobrevida, la única variable biopsicosocial asociado con patrón prolongado y/o sangrado frecuente fue condición médica previa. Cinco adolescentes (8%) se retiraron el IASE. Conclusiones: El IASE es una opción anticonceptiva segura y altamente eficaz para las adolescentes, independientemente de la paridad. La consejería es de gran importancia para fomentar la tolerancia y la adhesión al implante.

Objectives: To describe uterine bleeding patterns of adolescents using the long term etonogestrel contraceptive implant (ENG implant) attending a specialized adolescent sexual and reproductive health centre in Santiago, Chile, and test their association with bio-psychosocial variables. Methods: A retrospective cohort study of ENG implant users was conducted and data were analysed using the Generalized Estimating Equation, Kaplan Meier Survival Analysis and Log-Rank Test. Results: The cohort included 62 adolescents with and average age at inclusion of 16.2 years. Participants received contraceptive counselling prior to insertion of an ENG implant, and were followed up for three years. The most frequent bleeding patterns during the first year were amenorrhea (40.5%) and acceptable bleeding (27.1%), whilst the least frequent was prolonged and/or frequent bleeding (15.8%). According to the survival analysis, the only bio-psychosocial variable associated with prolonged and/or frequent bleeding was prior medical condition. Five adolescents (8%) withdrew from the treatment. Conclusions: The ENG implant is a safe and highly effective contraceptive option for adolescents, regardless of parity. Counselling is of great importance to foster tolerance and adherence to the ENG implant.

Diagnóstico de enfermagem Conhecimento Deficiente em usuárias de anticoncepcional oral combinado / Nursing diagnosis "Deficient Knowledge" in users of combined oral contraceptive

Objetivou-se analisar a acurácia das características definidoras do diagnóstico de enfermagem "Conhecimento Deficiente" em usuárias de AOC. Estudo transversal realizado com 97 mulheres em idade fértil em centro de saúde da família do nordeste brasileiro. A coleta de dados ocorreu de setembro a outubro de 2011, por meio de entrevista para identificação das características definidoras e dos fatores relacionados da Taxonomia II da NANDA-I 2012. O diagnóstico de enfermagem em questão apresentou prevalência de 58,8%; a característica definidora "seguimento inadequado de instruções" (57,7%) e o fator relacionado "interpretação errônea de informações" (58,8%) foram os mais prevalentes. "Seguimento inadequado de instruções" apresentou maior sensibilidade, 96,61(88.46 - 99.07), elevado valor preditivo positivo (VPP=98,28) e elevado valor preditivo negativo (VPN=95,35). Todas as características definidoras apresentaram a mesma especificidade, 97,62(87.68 - 99.58). Conclui-se que as características definidoras estudadas apresentaram sensibilidade, especificidade, valores preditivos positivos e negativos altos para o diagnóstico de enfermagem analisado.

Our objective was to analyze the accuracy of defining characteristics of the nursing diagnosis "Deficient Knowledge" in users of COC. A cross-sectional study conducted with 97 women in fertile age at a family health center in the Northeast Region of Brazil. The data collection was between September to October of 2011, through interviews to identify defining characteristics and factors related to Taxonomy II of NANDA-I 2012. The nursing diagnosis in question presented prevalence of 58.8%; the defining characteristic "inadequate following of instructions" (57.7%) and the related factor "wrong interpretation of information" were the most prevalent. "Inadequate following of instructions" presented higher sensitivity, 96.21 (88.46 ­ 99.07), high positive predictive value (PPV = 98.28) and elevated negative predictive value (NPV= 95.35). All defining characteristics presented the same specificity, 97.62 (87.68 ­ 99.58). It is concluded that studied defining characteristics presented high sensitivity, specificity, positive predictive values, and negative predictive values for the analyzed nursing diagnosis.

Knowledge of users of low-dose oral combined contraceptives about the method / Conhecimento de usuarias de anticoncepcional oral combinado de baixa dose sobre o metodo / El conocimiento de las usuarias sobre el metodo de anticonceptivos orales de dosis bajas combinados

OBJECTIVES: to identify the knowledge of users of combined oral contraceptive about correct use, side effects and complications; to verify the correlation between knowledge about the method with age, education, family income and time of use. METHOD: cross-sectional study performed in Fortaleza, Ceará, Brazil, from March to July 2010, with 294 women. Data were collected through interviews. RESULTS: 75% had substantial knowledge about the proper use and side effects and no knowledge about complications. The higher the educational level and family income, the higher the women's knowledge about the correct use of the method. Positive correlation suggests that women who used the method for longer knew more about its side effects. CONCLUSION: there are knowledge gaps about the method, which are influenced by socioeconomic variables and use time. .

OBJETIVOS: identificar o conhecimento de usuárias de anticoncepcional oral combinado sobre uso correto, efeitos colaterais e complicações relacionados a esse uso; verificar correlação entre o conhecimento sobre o método com idade, escolaridade, renda familiar mensal e tempo de uso. MÉTODO: estudo transversal, desenvolvido em Fortaleza, Ceará, Brasil, de março a julho de 2010, com 294 mulheres. Os dados foram coletados por meio de entrevista. RESULTADOS: setenta e cinco por cento apresentaram conhecimento substancial para o uso correto e efeitos colaterais e nenhum conhecimento para complicações. Quanto maior a escolaridade e a renda familiar maior o conhecimento das mulheres sobre o uso correto do método. Correlação positiva sugere que mulheres que usaram o método por mais tempo conheciam mais sobre seus efeitos colaterais. CONCLUSÃO: há lacunas no conhecimento sobre o método, sendo essas influenciadas por variáveis socioeconômicas e tempo de uso. .

OBJETIVOS: Identificar el conocimiento de las usuarias de anticonceptivos orales combinados sobre el uso correcto, los efectos secundarios y complicaciones, para verificar la correlación entre el conocimiento sobre el método con la edad, la educación, el ingreso familiar y el tiempo de uso. MÉTODO: Estudio transversal realizado en Fortaleza, Ceará, Brasil, de marzo a julio de 2010, con 294 mujeres. Los datos fueron recolectados a través de entrevistas. RESULTADOS: el 75% tenía un conocimiento considerable sobre el uso adecuado y efectos secundarios y ningún conocimiento acerca de las complicaciones. Cuanto mayor es el nivel educativo y el ingreso familiar, mayor conocimiento de las mujeres sobre el uso correcto del método. La correlación positiva sugiere que las mujeres que utilizaron el método para ya sabían más acerca de sus efectos secundarios. CONCLUSIÓN: Hay lagunas en los conocimientos sobre el método, que son influenciados por variables socioeconómicas y el tiempo de uso. .

Densidade mineral óssea em adolescentes usuárias de anticoncepcional oral combinado / Bone mineral density in adolescents users of combined oral contraceptive

Avaliar a densidade mineral óssea (DMO) e o conteúdo mineral ósseo (CMO) de adolescentes do sexo feminino, usuárias de anticoncepcional oral combinado (AOC) de baixa dosagem padronizado (EE 20 μg/ Desogestrel 150 μg), por período de um ano de seu uso e comparar os dados obtidos aos de adolescentes saudáveis da mesma faixa etária, não usuárias. Trata-se de um estudo controlado paralelo não randomizado. Sessenta e sete adolescentes, de 12 a 20 anos de idade, foram divididas em grupo de usuárias de AOC (n=41) e grupo controle (n=26). As adolescentes pertencentes aos dois grupos foram submetidas a exame físico geral e especial para obtenção de peso, estatura, índice de massa corpórea (IMC), avaliação dos caracteres sexuais secundários (critérios de Tanner), obtenção de idade óssea (IO) pelo método de Greulich & Pyle, ingestão de cálcio obtida pelo recordatório de 3 dias e obtenção da idade do evento menarca. As usuárias de AOC foram submetidas ao exame de Densitometria Óssea por atenuação de raio x de dupla energia (DXA), no momento de inclusão no trabalho; 6 e 12 meses depois, para obtenção de CMO (g) e DMO (g/cm2) em região lombar (L1-L4), fêmur proximal total, corpo total e corpo subtotal. O grupo controle foi avaliado através da DXA, no momento inicial; 12 meses depois, para obtenção de DMO e CMO, nos mesmos locais. A comparação entre as variáveis dos grupos de não usuárias e usuárias de AOC, no momento zero, foi realizada através do teste de Mann-Whitney, fixado o nível de significância de 5% ou utilizado o p-valor correspondente, enquanto para a comparação evolutiva dos grupos utilizou-se a variação das porcentagens das medianas das variáveis relativas à massa óssea, nos momentos inicial e final...

To evaluate bone mineral density (BMD) and bone mineral content (BMC) in female adolescents taking a standard low dose (EE 20μg/ Desogestrel 150μg) combination oral contraceptive (COC) over a one year period and comparing them to healthy adolescents from the same age group not taking COC’s. A non-randomized parallel control study with 67 adolescents from 12 to 20 years of age divided into user (COC; n=41) and control (n=26) groups. Both groups were submitted to a general physical and specific examination for weight, height, body mass index (BMI), secondary sexual characteristics evaluation (Tanner criteria), bone age (BA) by the Greulich & Pyle method, calcium intake by 3 days diet recording, and obtaining age at menarche. COC users underwent bone density exam by dual-energy X-ray absorptiometry (DXA) at time of inclusion in the study and at 6 and 12 months, to obtain BMC (g) and BMD (g/cm2) in the lumbar (L1-L4) and total proximal femur regions, for whole body and subtotal whole body. The Control group underwent DXA at inclusion and 12 months to obtain BMD and BMC in the same locations. Comparisons between groups at moment zero was through the Mann-Whitney test with significance level fixed at 5% or corresponding p value; evolutive group comparisons used variations in median percentages for bone mass variables at start and final moments. There were no statistical differences in chronological (CA) and BA, anthropometric variables, and bone densitometry results at the initial moment between COC and control groups. However after 12 months follow-up, COC users presented low bone mass acquisition in the lumbar spine BMD and BMC median variation percentages between initial and final moments (+2.07% and +1.57% respectively) while the control group presented expressive variations (+12.16% and +16.84% respectively)...

Influence of combined oral contraceptives on the periodontal condition

Most studies investigating the impact of oral contraceptives have been performed some years ago, when the level of sexual hormones was greater than the actual formulations. Objective: The aim of this study was to evaluate the effects of current combined oral contraceptives (COC) on periodontal tissues, correlating the clinical parameters examined with the total duration of continuous oral contraceptive intake. Material and methods: Twenty-five women (19-35 years old) taking combined oral contraceptives for at least 1 year were included in the test group. The control group was composed by 25 patients at the same age range reporting no use of hormone-based contraceptive methods. Clinical parameters investigated included pocket probing depth (PD), clinical attachment level (CAL), sulcular bleeding index (SBI) and plaque index (Pl.I). Data were statistically evaluated by unpaired t test, Pearson’s correlation test and Spearman’s correlation test. Results: The test group showed increased PD (2.228±0.011 x 2.154±0.012; p<0.0001) and SBI (0.229±0.006 x 0.148±0.005, p<0.0001) than controls. No significant differences between groups were found in CAL (0.435±0.01 x 0.412±0.01; p=0.11). The control group showed greater Pl.I than the test group (0.206±0.007 x 0.303±0.008; p<0.0001). No correlation between the duration of oral contraceptive intake, age and periodontal parameters was observed. Conclusions: These findings suggest that the use of currently available combined oral contraceptives can influence the periodontal conditions of the patients, independently of the level of plaque accumulation or total duration of medication intake, resulting in increased gingival inflammation.

Anticoncepcionais orais combinados em regime estendido / Combined oral contraceptives in extended regimen

Denominam-se regimes estendidos em contracepção oral combinada a utilização de pílulas por mais de 28 dias sem pausa, visando a supressão da menstruação. Incluem o uso contínuo dos contraceptivos, bem como de regimes com intervalos trimestrais. Os questionamentos acerca da necessidade da menstruação, bem como dos intervalos mensais entre as usuárias de anticoncepcionais hormonais, motivou, nos últimos anos, o interesse crescente por regimes contraceptivos não convencionais. Nesse sentido, a conveniência e a melhora dos sintomas como cólicas, cefaleia e inchaço figuram entre as principais indicações dos regimes estendidos, além do possível efeito sobre doenças menstruais relacionadas. O propósito deste estudo foi identificar os principais aspectos referentes ao uso dos anticoncepcionais em regime estendido, com ênfase sobre as indicações, formulações disponíveis, padrão de sangramento, efeitos adversos e perfil metabólico

Extended regimens in combined oral contraception mean continuous administration, greater than 28 days of active hormone, in order to avoid menstruation. Extended regimens include some kind of contraception with no interval (as continuous) and with intervals every three months. Questions about the necessity of menstruation, as well as monthly intervals between hormonal contraceptive has motivated the growing interest in unconventional contraceptives regimens. Convenience and improved symptoms such as cramping, bloating and headache are among the main indications for extended regimens, in addition to the possible effect on menstrual-related diseases. The purpose of this study was to identify the main aspects regarding the use of contraceptives in extended regimens, with emphasis on indications, formulations available, bleeding patterns, adverse effects and metabolic profile

Impacto dos contraceptivos hormonais na densidade óssea: evidências atuais para contracepção na adolescência / Impact of hormonal contraceptives on bone density: current evidences for contraception in adolescence

Devido aos efeitos adversos dos contraceptivos hormonais, algumas mulheres são privadas de seus benefícios, que se estendem além da contracepção. Especialmente em adolescentes, é preocupante o impacto dos hormônios sobre o osso. Buscando reunir evidências nesse sentido, três revisores independentes fizeram buscas nas bases de dados Medline, Lilacs, Ibecs, Scielo e Cochrane, utilizando descritores relacionados à contracepção e densidade óssea. Foram critérios de inclusão: revisões sistemáticas e estudos com nível de evidência A e B. Foram excluídos estudos com contraceptivos utilizados para fins terapêuticos e não contraceptivos. Das 66 publicações encontradas, foram selecionados 15 estudos, e evidenciou-se que compostos com progesterona isolada de depósito e possivelmente os de baixa dose estrogênica têm impacto negativo na fase do pico de massa óssea. Contudo, o efeito esteve restrito à idade de iniciação e ao tempo de uso, havendo recuperação após interrupção da contracepção. Não há evidências de relação entre uso de contraceptivos e fraturas. O aconselhamento contraceptivo deve considerar o efeito negativo que a progesterona isolada de depósito e a baixa dose estrogênica podem ter sobre a massa óssea na adolescência, considerando que tal efeito é reversível e limitado ao tempo de uso

Due to the adverse effects of hormonal contraceptives, some women are deprived of the benefits they provide that extend beyond contraception. In adolescents, the main concern is the impact hormones can have on their bone structure. Three independent reviewers researched the databases Medline, Lilacs, Ibecs, Scielo and Cochrane, by using descriptions related to contraception and bone density. The inclusion criteria were: systematic reviews and studies with levels of evidence A and B. Contraceptives used for therapeutic purposes, other than contraception itself, were excluded from the study. Of the 66 publications found, 15 studies were selected. Compounds isolated from progesterone deposit, and possibly the low-dose estrogen, have a negative impact on the stage the bone mass peaks, but the effect was restricted to the age of initiation and the time of use, with recovery after discontinuation of contraception. There is no evidence of a relationship between the use of contraceptives and bone fractures. The negative effects that the deposit of progesterone and low-dose estrogen may have on bone mass should be taken into account when adolescents engage in the use of contraceptives ? bearing in mind that said effects are reversible and limited to the time of use

Experiencia piloto con el uso extendido de un anticonceptivo oral combinado de baja dosis de estrógeno / Extended use of an oral combined contraceptive pill with low estrogen dose: pilot experience

Objetivo: Evaluar en una experiencia piloto la aceptabilidad y bienestar de la usuaria, después de un periodo de 12 meses de un anticonceptivo hormonal combinado oral de baja dosis estrogénica, con modalidad de uso extendido de 84 píldoras activas consecutivas, seguidas de 7 días de placebo. Método: Se incorporan 25 mujeres voluntarias que usan una combinación de 20 ug de etinilestradiol + 3 mg de drospirenona, con un tiempo de uso de 12 meses. En calendario de registro diario se consignan los días de sangrado o goteo genital así como todo tipo de fármaco ingerido. Al término de los 12 meses se efectúa una encuesta respecto al grado de satisfacción con la posología recibida. Resultados: 13 usuarias (52 por ciento) cumplen los 12 meses de uso. Todas ellas manifiestan un alto grado de conformidad, destacando las ventajas de presentar periodos menstruales ocasionales, mejoría marcada en la sintomatología compatible con el síndrome de tensión premenstrual con el consiguiente incremento del bienestar general. Siete usuarias (28 por ciento) no terminan el estudio por razones médicas, siendo 6 de estas por alteraciones de los flujos rojos y en 5 casos (20 por ciento) se producen retiros no médicos. Conclusión: Esta experiencia, que es la primera con la formulación descrita, confirma en un porcentaje de usuarias las bondades adicionales reportadas en las experiencias previas con otros productos similares, respecto al uso extendido de anticoncepción hormonal oral en un grupo de mujeres que deseaban espaciar sus periodos menstruales.

Objetives: A pilot study designed in order to know about the acceptability of an oral combined contraceptive pill, with low estrogen dose used in an extended way of 84 consecutive days, followed by 7 days of no pills ingestion during a scheduled follow up of 1 year. Methods: 25 volunteers women were recruited among those which wants to use oral combined contraceptive pills and who accepted this extended way of use. Combined contraceptive pills contains each 20 ug of ethinylestradiol plus 3 mg of drosperinone. At admission women were provided with menstrual diary cards in order to check all bleeding days plus any extra pharmaceutical compound received. At the end of the 12 months follow up an interview was done in order to know women experiences and acceptability of this extended way of use. Results: 52 percent of women end the study at the scheduled 12 months use. All of them feel that the main advantages of these extended way of use were to have few menstrual periods and improving premenstrual symtomatology with better quality of life. 7 women (28 percent) did not finish the study because of medical reasons being due in 6 of these for bleeding disturbances. Conclusions: This report is pioneer with the use this hormone combination in this extended type way of use. Results confirm previous positive reports experiences using another similar hormonal compounds with this extended way of use in women who want to reduce the interval of their menstrual periods.

Beneficios no anticonceptivos de 0, 02 mg de etinilestradiol/2 mg de acetato de clormadinona administrados en un régimen de 24+4 días / Non-contraceptive benefits of 0.02 mg ethinylestradiol /2 mg chlormadinone acetate in a 24 +4 days intake regimen

Objetivo: Demostrar la influencia sobre las molestias emocionales y físicas (beneficios no anticonceptivos) experimentadas durante el primer año de uso de un anticonceptivo oral combinado (AOC) que contiene 0,02 mg de etinilestradiol (EE) y 2 mg de acetato de clormadinona (ACM) administrado en un régimen de 24 + 4 días de placebo. Diseño del estudio: Análisis adicional de las sensaciones subjetivas registradas en los diarios de 1665 participantes de un estudio de Fase III multicéntrico, no controlado, de administración múltiple, después de 13 ciclos de EE/ACM en un régimen de administración de 24 + 4 días, publicado previamente. Resultados: Se informó de menor frecuencia de molestias emocionales y físicas en el ciclo de medicación 13 en comparación con los datos en la admisión y en el ciclo 1. La incidencia de ánimo depresivo se redujo en 84,5 por ciento y 72,2 por ciento respectivamente, y la irritabilidad en 87,3 por ciento y 66,0 por ciento. Las cefaleas se redujeron en 75,5 por ciento y 74,7 por ciento, las molestias mamarias en 77,1 por ciento y 66,1 por ciento, y la dismenorrea preexistente en 77,9 por ciento y 67,6 por ciento respectivamente. El abandono prematuro del estudio a causa de las molestias fue marginal, y el perfil del sangrado fue aceptable. Conclusiones: Un AOC de baja dosis que contiene 0,02 mg de EE + 2 mg de ACM, administrado en un régimen de 24 + 4 días, reduce significativamente la mayor parte de las molestias emocionales y físicas que se presentan durante los ciclos espontáneos de las mujeres, y se combina con un adecuado perfil de sangrado.

Objective: To demonstrate the influence on physical and psychological complaints during the first year of intake of the combined oral contraceptive (COC) 0.02 mg ethinylestradiol (EE)/2 mg chlormadinone acetate (CMA), administered in a regimen of 24 days of CMA/EE intake followed by 4 days of placebo intake. Study design: The subjective feelings of non-contraceptive benefits registered in women's diaries of 1,665 subjects participating in a multicentre, uncontrolled, multiadministration, Phase III trial, published elsewhere, were analyzed post-hoc after 13 cycles intake of EE/CMA in a 24 +4 days intake regimen. Results: Emotional complaints were reported less frequently at medication cycle 13 compared with admission and cycle 1. Depressive mood was reduced by 84.5 percent and 72.2 percent, irritability by 87.3 percent and 66.0 percent; physical complaints were also reduced: headaches by 75.5 percent and 74.7 percent, breast discomfort by 77.1 percent and 66.1 percent; pre-existing dysmenorrhea by 77.9 percent and 67.6 percent. Premature termination due to complaints was only marginal, the bleeding profile was accepted. Conclusions: The low-dose COC, 0.02 mg EE/2 mg CMA, administered in a 24 +4 day regimen, reduces significantly most of the emotional and physical complaints occurring during spontaneous cycles of women, combined with an adequate bleeding profile.

Manejo do sangramento inesperado em usuárias de métodos contraceptivos hormonais: revisão das recomendações atuais / Management of unscheduled bleeding in women using hormonal contraceptive: review of current recommendations

Os objetivos desta revisão foram identificar e analisar as principais recomendações atuais relativas ao manejo do sangramento inesperado em usuárias de anticoncepcional hormonal. Foram revisadas as principais diretrizes publicadas nos últimos dez anos. Quatro bases de dados eletrônicas foram consultadas (Medline, LILACS, Scielo, CINAHL®). De um total inicial de 14.130 citações, 14 foram selecionadas para inclusão. As principais recomendações sugerem que as mulheres que optam por métodos hormonais devem ser orientadas quanto à possibilidade da ocorrência de sangramentos inesperados. Tais sangramentos podem desaparecer espontaneamente com a persistência no uso do método. Na maioria das vezes, esta intercorrência não afeta a eficácia anticonceptiva do método, e recomenda-se não criar a expectativa de que irá ocorrer amenorreia na vigência do uso de métodos contraceptivos hormonais. Esta revisão pode ser útil na prática clínica, dada a importância do tema e a frequência desse tipo de queixa nos ambulatórios de tocoginecologia

The objectives of this review were to identify and analyze the main current recommendations on the management of unscheduled bleeding in women using hormonal contraceptives. The main guidelines published during the last ten years were reviewed. Four electronic databases were consulted (Medline, LILACS, Scielo, CINAHL®). From the total of 14,130 citations, 14 were selected for inclusion. The main recommendations suggest that women using hormonal contraceptives should be informed about the possible occurrence of unscheduled bleeding. This bleeding may disappear spontaneously with the persistent use of the method. Most of the time this event do not affect the contraceptive effectiveness of the method, and women should not expect the amenorrhea during the use of hormonal contraceptive methods. This review can be useful for clinical practice, considering the importance of this topic and the frequency of this kind of complaint in tocogynecology clinics

A clinical study of transdermal contraceptive patch in Thai adolescence women.

OBJECTIVE: To study cycle control, compliance and safety of a transdermal contraceptive patch in adolescent Thai women. MATERIAL AND METHOD: Fifty-eight healthy women were assigned to receive 3 cycles of contraceptive patch (ethinyl estradiol 20 microg and norelgestromin 150 microg/day). All participants aged 16-20 years were invited to participate from the family planning clinic at King Chulalongkorn Memorial Hospital. Data were collected on adverse effects, perceived advantages and disadvantages, body weight, blood pressure, patch detachments and compliance. Data were analyzed using mean, percentage and student's t-test. RESULTS: The participants' average age was 19.4 years, height 158.8 cm, weight 51.8 kg, BMI 20.8 Kg/m2. The most location of patch application was the abdomen and the most adverse event was breast tenderness (31.0%) followed by application site reaction, nausea vomiting and headache respectively. The breast symptom was mild in severity. The participants reported decrease in dysmenorrhea and shorter duration of bleeding. There were no significant changes in body weight and blood pressure. The improvement of their facial acne was reported. There were no pregnancies during use and the adhesion of the contraceptive patch is excellent. Partial patch detachment was reported in only 6.9%. No completed patch detachment was found. CONCLUSION: The present study found an overall positive impression of a new transdermal contraceptive patch. The good compliance and few side effects were demonstrated. The adhesive patch contraceptive was excellent.

Experiencia chilena con el uso de un anticonceptivo oral combinado de acetato de clormadinona/etinilestradiol: estudio no intervencional / Efficacy, tolerability and safety of an oral contraceptive containing ethinylestradiol/chlormadinone acetate: the Chilean experience

Objetivos: Evaluar en mujeres chilenas, la eficacia, tolerabilidad y seguridad del anticonceptivo Belara® (Acetato de Clormadinona 2 mg y Etinilestradiol 0,03 mg) (ACM/EE). Métodos: Estudio no intervencional, multicéntrico, prospectivo, de 6 ciclos de seguimiento, evaluando efectividad anticonceptiva, estabilidad de ciclo, tolerabilidad, seguridad y acción sobre peso, piel y cabello. Resultados: ACM/EE fue tomado por 593 mujeres durante 3426 ciclos. Hubo 2 embarazos durante el seguimiento, uno voluntario y otro involuntario; en ninguno de los casos se consideró como falla del método. Durante el tratamiento se observó mejoría progresiva en la estabilidad del ciclo menstrual, sangrado intermenstrual, amenorrea y dismenorrea, con frecuencia de 4,5%, 1,4%, 2,5% y 11,6% al sexto ciclo, respectivamente. El porcentaje de mujeres con piel normal incrementó de 25,5% antes del tratamiento a 63,6% después de seis meses de administración continua de ACM/EE. El peso promedio se mantuvo estable durante el tratamiento. Los eventos adversos mas frecuentes fueron: cefalea (10,4%), aumento de peso (8,3%), mastalgia (6,1%) y trastornos del ánimo (2%). El 11% de las usuarias (n=63) suspendió ACM/EE antes de terminar los 6 meses de observación. El 97,2% de los médicos y 96,1% de las usuarias calificaron los resultados con ACM/EE como “buenos o muy buenos”. Conclusiones: Similar a los resultados reportados en la literatura europea, este estudio realizado en población chilena, confirma la eficacia, seguridad y tolerabilidad de ACM/EE así como los beneficios antiandrogénicos adicionales sobre piel y cabello, y su efecto neutral sobre el peso corporal.

Objectives: To evaluate the efficacy, tolerability and safety of the contraceptive Belara® (chlormadinone 2 mg/ethinylestradiol 0.03 mg; ACM/EE) in chilean women. Methods: Non interventional, multicentric, prospective, 6 cycles follow up trial, evaluating contraceptive efficacy, cycle stability, tolerability, safety, and effect on hair and skin. Results: AMC/EE was taken by 593 women for a total of 3426 cycles. Two pregnancies were reported during follow-up, one voluntary and the other involuntary; they were not considered failure of the method. Progressive improvement in cycle stability, intermenstrual bleeding, amenorrhea and dysmenorrhea occurred during the treatment period reaching 4.5%, 1.4%, 2.5% y 11.6% at the 6th cycle respectively. The percentage of women with normal skin increased from 25.5% prior to treatment, to 63.6%, after taking ACM/EE during six months. The average body weight was maintained throughout treatment. The most frequent adverse events were: headache (10.4%), weight increase (8.3%), breast tenderness (6.1%) and mood changes (2%). An 11% of users (n=63) discontinued the use of ACM/EE before completing the observational period of six months. A 97.2% of physicians and 96.1% of users qualified the results with ACM/EE as “good or very good”. Conclusions: Similar to the results reported in the European literature, this study in the Chilean population confirmed the efficacy, safety and tolerability of ACM/EE, together with its antiandrogenic benefits on skin and hair, and its neutral effect on body weight.

Avaliação da tolerabilidade, aceitabilidade e controle do ciclo em adolescentes usuárias de anticoncepcional hormonal combinado oral de baixa dose com gestodeno e etinilestradiol / Assessment of the tolerability, acceptability and cycle control in tenager users of oral low dose combined hormonal contraceptive with gestodene and ethinylestradiol

OBJETIVO: Os anticoncepcionais hormonais orais vêm sofrendo progressiva redução de dose desde as suasformulações iniciais, sem, no entanto comprometer sua eficácia e com considerável melhora do seu perfil de segurança. Entre jovens adolescentes, a satisfação com essas novas formulações tem sido maior que a de usuárias de outros métodos. Isso é particularmente conveniente, já que nessa faixa etária ocorre a maioria das gestações não-desejadas. O impacto causado por essas gestações e os riscos associados ao alto percentual de abortos justifica o desenvolvimento e a análise de novas formulações contraceptivas em pacientes adolescentes. Nosso objetivo neste estudo foi avaliar a tolerabilidade, aceitabilidade e controle do ciclo de um contraceptivo hormonal oral de baixa dose contendo gestodeno (75 microgramas) e etinilestradiol (20 microgramas), em mulheres adolescentes. MÉTODOS: Este foi um ensaio clínico aberto, não-comparativo e multicêntrico conduzido em pacientes ambulatoriais. A idade das participantes deste estudo variou de 14 a 20 anos. Estatísticas descritivas foram empregadas para a análise do controle do ciclo e segurança. Alterações de peso, estatura, pressão arterial, freqüência cardíaca, dados laboratoriais, duração do ciclo, e sangramento de privação foram avaliados pelo teste t pareado. RESULTADOS: O presente estudo avaliou um número significativo de ciclos (918 ciclos) para permitir uma análise adequada dos sangramentos de privação e intermenstruais na vigência da medicação proposta. Conforme observamos, o emprego da formação GTD75/EE20 ofereceu um bom controle do ciclo, praticamente não alterando o padrão próprio da usuária, prévio ao uso do contraceptivo. CONCLUSÕES: A formulação contraceptiva GTD75/EE20 traz características muito adequadas à sua indicação em adolescentes que, para aceitação e aderência apropriadas, necessitam de um método seguro, com bom controle de ciclo, eficácia contraceptiva, bom controle do peso corporal e baixa incidência de reações adversas

A randomized trial on the impact of starting day on ovarian follicular activity in very low dose oral contraceptive pills users.

In a randomized trial, the impact of starting day (the first and the seventh day of the period) on ovarian follicular activity was assessed during administration of a very low dose of oral contraceptive pills (20 microgram (mcg) ethinyl estradiol (EE) and 75 mcg gestodene (GS) [Meliane, Schering, Germany]). One hundred and sixty healthy women aged: 23-44 years, who had a regular cycle, and who were not using any type of oral contraceptive (OCs) steroid were studied at the Family Planning Clinic of King Chulalongkorn Memorial Hospital, Bangkok, Thailand. In the trial, each subject received a package of Meliane. They were blockwise randomized, 1:1 ratio; in the first group, subjects began their pills on the first day of their period (n = 80) and the other group, the seventh day of their period (n = 80). During the treatment cycle, ovarian activity was evaluated by transvaginal sonography (TVS) to determine the follicular-like structure (FLS). Ovulation was defined as the dominant FLS detected by TVS and followed-up every other day until its collapse. It occurred in 0 of 77 cases who started on the first day of their period and occurred in 8 of 78 cases of the group which started on the seventh day of their period. The difference was of statistical significance (p = 0.006). The result of this clinical trial is beneficial information for users of OCs containing 20 mcg EE who delay start of the OCs package.

Effects of a monophasic pill containing 20 microg ethinylestradiol and 150 microg desogestrel on lipid metabolism in Thai women.

OBJECTIVES: To investigate the effects of a monophasic oral contraceptive containing 20 microg ethinylestradiol and 150 microg desogestrel (Mercilon) on lipid metabolism in Thai women. METHOD: The study was carried out at the Family Planning Clinic of King Chulalongkorn Memorial Hospital, Bangkok, Thailand. Twenty women of fertile age were enrolled and treated with the study oral contraceptives for 12 cycles. Lipid parameters were assessed before treatment and periodically during treatment. RESULTS: There was a significant increase in triglyceride, high desity lipoprotein-cholesterol, apolipoproteins AI and AII. No significant changes were found in total cholesterol, low density lipoprotein-cholesterol and apolipoprotein B. CONCLUSION: The effects of the oral contraceptive containing 20 microg ethinylestradiol and 150 microg desogestrel on lipid parameters in Thai women appear to be favorably beneficial.

Clinical study of a monophasic pill containing 20 microg ethinylestradiol and 150 microg desogestrel in Thai women.

OBJECTIVES: To evaluate the contraceptive reliability and clinical effects of a monophasic oral contraceptive containing 20 microg ethinylestradiol and 150 microg desogestrel (Mercilon) in Thai women. METHOD: The study was carried out at the Family Planning Clinic of King Chulalongkorn Memorial Hospital, Bangkok, Thailand. One hundred and forty six healthy women of fertile age were enrolled and treated with the study oral contraceptives for 12 cycles. Clinical data of vaginal bleeding, side effects, blood pressure and body weight were assessed periodically. RESULTS: One thousand four hundred and twenty five cycles were evaluated. No conception occurred. The cycles were almost regular. The incidence of irregular bleeding was highest in the first cycle, after the third cycle, the value was below 4 per cent. Side effects were very few. There was no change in blood pressure. A slight decrease in mean body weight was observed. CONCLUSION: The oral contraceptive containing 20 microg ethinylestradiol and 150 microg desogestrel has high contraceptive efficacy, good cycle control and minimal side effects.

Eficácia, tolerabilidade, controle de ciclo e bem-estar em mulheres acima de 35 anos utilizando um contraceptivo de baixa dose contendo gestodeno e etinilestradiol (Harmonet) / Efficacy, tolerability, cycle control and welfare in woman above 35 years using a low dose contraceptive containing gestodene and ethynilestradiol (Harmonet)

Um estudo multicêntrico foi conduzido em 14 centros brasileiros para avaliar a eficácia, tolerabilidade, controle de ciclo e bem-estar em mulheres, não fumantes, acima de 35 anos utilizando um contraceptivo de baixa dose contendo gestodeno e etinilestradiol, durante seis ciclos de tratamento. Participaram do estudo 180 mulheres na faixa etária de 35 a 47 anos, das quais 158 (87,8 por cento) completaram os seis ciclos de tratamento. Nenhuma gravidez ocorreu entre as usuárias do contraceptivo em estudo. Um total de 950 ciclos foi avaliado. Em 92,5 por cento dos ciclos não houve spotting nem sangramento de escape. Ocorreu spotting em 7,2 por cento dos ciclos e sangramento de escape em 0,3 por cento dos ciclos. Com relação ao número de mulheres, 82,2 por cento não apresentaram spotting nem sangramento de escape em nenhum momento do ciclo. Observou-se uma diminuição significativa, indicativa de melhora, com relação ao pré-tratamento, nos escores do questionário de Moos de desconforto menstrual relativos a dor, concentração, mudanças comportamentais, afeto negativo, reações autonômicas, retenção hídrica e controle. Não houve alterações clinicamente significativas de peso, pressão arterial nem resultados laboratoriais. A adesão ao tratamento foi boa, tendo havido esquecimento de tomada de uma ou mais pílulas em apenas 3 por cento do total de ciclos; 12,2 por cento das mulheres não completaram o período de seis ciclos de tratamento, sendo que em 1,1 por cento dos casos a razão para descontinuação foi atribuída a efeitos adversos. Os resultados permitem concluir pela eficácia contraceptiva, bom controle de ciclo, tolerabilidade e bem-estar associados ao uso do contraceptivo de baixa dose contendo gestodeno e etinilestradiol em mulheres acima de 35 anos.