One-year adolescent bone mineral density and bone formation marker changes through the use or lack of use of combined hormonal contraceptives / Alterações na densidade mineral óssea e nos marcadores de formação óssea em adolescentes usuárias ou não de contraceptivos hormonais orais combinados por período de um ano

Abstract Objective: The objective of this study was to evaluate the effects of two low-dose combined oral contraceptives on bone metabolism in adolescents for one year. Methods: This was a quasi-experimental study. The adolescents were divided into three groups: oral contraceptives 1 (n = 42) (20 µg EE/150 µg desogestrel), oral contraceptives 2 (n = 66) (30 µg EE/3 mg drospirenone), and a control group (n = 70). Adolescents underwent anthropometric assessment and densitometry (dual-energy X-ray). Bone age and bone formation markers (osteocalcin and bone alkaline phosphatase) were evaluated. The oral contraceptives users were evaluated again after 12 months. Linear regression analysis was used to indirectly study the effect of each additional year of chronological age on anthropometric and densitometric variables as well as on bone markers in the control group. Results: At study entry, no significant differences were observed between the oral contraceptives 1, oral contraceptives 2, and controls in the analyzed variables. Linear regression analysis showed an increase in bone mineral density and bone mineral content for each additional year. There was a significant reduction in bone alkaline phosphatase levels; no significant difference was observed for osteocalcin in control individuals. Comparison of dual-energy X-ray variables at baseline and after one year showed no significant differences in the oral contraceptives 1 or oral contraceptives 2 groups. A significant reduction in bone alkaline phosphatase and osteocalcin levels was observed in both the oral contraceptives 1 and oral contraceptives 2 groups. Conclusion: Adolescent women gain peak bone mass during this phase of life. Two low-dose combined oral hormonal contraceptives were associated with lower bone gain and lower bone formation markers than in untreated controls.

Resumo: Objetivo: O objetivo deste estudo foi avaliar os efeitos de dois contraceptivos orais combinados de baixa dosagem por um ano sobre o metabolismo ósseo em adolescentes. Métodos: Este foi um estudo quase experimental. As adolescentes foram divididas em três grupos: contraceptivos orais 1 (n = 42) (20 µg de EE/150 µg de desogestrel), contraceptivos orais 2 (n = 66) (30 µg EE/3 mg de drospirenona) e grupo controle (n = 70). As adolescentes foram submetidas à avaliação antropométrica e densitometria (raio-X de dupla energia). Foram avaliados a idade óssea e os marcadores de formação óssea (osteocalcina e fosfatase alcalina óssea). As usuárias de contraceptivos orais foram novamente avaliadas após 12 meses. A análise de regressão linear foi utilizada para estudar, indiretamente, o efeito de cada ano adicional da idade cronológica sobre as variáveis antropométricas e densitométricas e sobre os marcadores ósseos no grupo de controle. Resultados: No início do estudo, não foram observadas diferenças significativas nas variáveis analisadas entre as usuárias de contraceptivos orais 1, contraceptivos orais 2 e o grupo controle. A análise de regressão linear mostrou um aumento na densidade mineral óssea e no conteúdo mineral ósseo para cada ano adicional. Houve uma redução significativa nos níveis de fosfatase alcalina óssea e não foi observada diferença significativa para osteocalcina nos indivíduos controles. A comparação das variáveis do raio-X de dupla energia no início e após um ano não mostrou diferença significativa no grupo de contraceptivos orais 1 ou contraceptivos orais 2. Foi observada uma redução significativa nos níveis de fosfatase alcalina óssea e osteocalcina nos dois grupos contraceptivos orais 1 e contraceptivos orais 2. Conclusão: As adolescentes atingiram o pico de massa óssea durante essa fase da vida. Duas formulações de contraceptivos hormonais orais de baixa dosagem, após um ano de uso, se associaram a menor incremento na densidade mineral óssea e menor concentração de marcadores de formação óssea quando confrontados com resultados de adolescentes não usuárias de contraceptivos.

Métodos contraceptivos reversíveis de longa duração no Sistema Único de Saúde: o debate sobre a (in)disciplina da mulher / Long-acting reversible contraception methods in the Brazilian Unified National Health System: the debate on women's (in)discipline

Resumo Recentemente a Federação Brasileira das Associações de Ginecologia e Obstetrícia submeteu ao Ministério da Saúde uma solicitação para oferta no Sistema Único de Saúde de métodos contraceptivos reversíveis de longa duração (LARC), para jovens mulheres de 15 a 19 anos. Os dois dispositivos a serem incluídos seriam o implante subdérmico liberador de etonogestrel, com duração de três anos, e o sistema intrauterino liberador de levonorgestrel, com duração de cinco anos. O Ministério da Saúde abriu então consulta pública para avaliar tal introdução, terminando por decidir contrariamente à inclusão destes métodos na rede pública de saúde. O artigo discute as estratégias discursivas utilizadas para fundamentar e justificar a aceitação e aplicabilidade destes métodos em "populações especiais". O debate sobre o planejamento reprodutivo precisa compreender melhor as descontinuidades contraceptivas no uso de métodos, a centralidade da contracepção de emergência e o quanto as hierarquias de gênero dificultam uma prática contraceptiva segura. Ao contrário, a ênfase na (in)disciplina da mulher no tocante aos cuidados com a utilização de métodos contraceptivos de uso regular termina por reforçar sua condição de menoridade social.

Abstract Recently, the Brazilian Federation of Gynecology and Obstetrics Associations submitted a request to the Brazilian Ministry of Health for an introduction of long-acting reversible contraception (LARC) methods for young women aged 15 to 19 years in the Brazilian Unified National Health System. The two devices to be included were the etonogestrel-releasing subdermal implant (ENG implant), with a duration of three years, and the levonorgestrel-releasing intrauterine system (LNG-IUS), lasting five years. The Ministry of Health then launched a public inquiry to evaluate this introduction, deciding against the inclusion of these methods in the public health services. The article discusses the discursive strategies used to justify the acceptance and applicability of these methods in "special populations." The debate on family planning needs to understand fully the discontinuity of contraception in the use of such methods, the central concept of emergency contraception, and how gender hierarchies prejudice safe contraceptive practice. On the contrary, the emphasis on the (in)discipline of women regarding care with regular-use contraceptive methods effectively reinforces their condition of social minority.

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.

One-year assessment of women receiving sub-dermal contraceptive implant at Siriraj Family Planning Clinic.

BACKGROUND: The single-rod Implantable contraceptive method, called 'Implanon', has been introduced for use in Thailand since the 1990s. The outstanding attribute was that it requires only a few minutes for insertion and removal as it has only one capsule. The single-rod implant was used in women at Siriraj Hospital in 2006. The present study looked at characteristics of women, complications of insertion and removal, menstrual events that occurred to women during one year of use and reason for removal of the method. MATERIAL AND METHOD: This was a retrospective clinic based study. All women's record files were examined at Siriraj Hospital's Family Planning Clinic. There were 166 women enrolled to undergo this method, and only 89 women (54.6%) came back for the one-year follow-up visit. Women's accounts on irregularity of menses, complaints during method used and reason for discontinuation, pregnancy and body weight change were assessed. RESULTS: Most women (68%) using the implant contraceptive method were 29 years of age with 74% of vocational or lower education. Their BMI was 22.66 +/- 4.06 Insertion time was about 1 minute with no difficulty or complication. Of those women, 40.4% of them considered having regular menstrual cycle and 30.3% had regular menstrual flow for a few months alternately with no menses for a few months. Prolonged menstrual bleeding was the most complaint in this group of women. Amenorrhoea was also reported. Vertigo had occurred to some women without reported medication. One woman asked for the removal of the method due to pain at the implanted site after 8 months of use. Removal time was around 2-3 minutes. There was no pregnancy that occurred in the course of one year of use. CONCLUSION: Of 89 women using the implant contraceptive method, menstrual irregularity was the important issue that women complained about. However, the removal of the method in one woman was due to the pain at the implanted site. There was no difficulty or complications in insertion or removal of the implant. Close counseling about side effects of the method is emphasized during use to maintain long-term use or until completion of the duration of the device.

A postmarketing observational study assessing acceptability and reliability of desogestrel only contrapceptive pill (Cerazette) in Indian women.

A postmarketing observational study was carried out in a prospective, open and multi-centric manner monitoring a treatment period of 4 cycles (4 x 28 days) among Indian women of child bearing age to determine the acceptability and reliability of desogestrel (75 microg/day), an oestrogen-free pill. It involved 299 subjects recruited at each of 20 centres spread all over India. The study duration for each subject was 16 weeks with follow-up visits at 4, 8 and 16 weeks intervals. At each follow-up visit, subjects were evaluated for any failure of contraception, change in bleeding pattern and other adverse events. Of the study subjects, 238 (79.6%) continued the study for 4 cycles and were thus considered eligible for analysis of bleeding patterns with no failure of contraception. In addition, the physician's as well as patient's global assessment, demonstrated a "very good" response in majority of subjects (> 84%). A sizeable number of cases (47.9%) had infrequent episodes (1 to 5) of bleeding--spotting during the shifted reference period, while 41.2% experienced amenorrhoea. There was no clinically significant change in blood pressure or body weight. Of the 299 such subjects enrolled, 53 subjects were lost to follow-up and did not come for the 1st follow-up visit. Hence, out of the 246 subjects, 21.1% presented with 78 separate adverse events during 960 treatment cycles. None of the reported adverse events were severe and there was not even a single serious adverse effect during the course of the study. Nausea, breast tenderness and headache (7.7%, 10.1% and 9.7% respectively) were the most frequent adverse events observed during the study. Desogestrel 75 mg/day was well accepted in majority of Indian women. It provides good contraceptive efficacy, with a lower incidence of irregular bleeding and spotting episodes.

Evolución a un año de los efectos adversos, en una cohorte de pacientes con implante subdérmico de Desogestrel / Adverse effects of subdermal Desogestrel implants: one year evolution

Objetivo: El propósito de la investigación fue evaluar la evolución a un año los efectos adversos en una cohorte de pacientes con implante subdérmico de desogestrel. Método: Se incluyeron pacientes portadoras de implante que tenían como mínimo tres meses de uso, previo consentimiento informado. Se realizaron 4 mediciones en forma trimestral, registrándose los efectos más frecuentes referidos por la paciente. El análisis incluyó porcentajes, promedios e intervalos de confianza al 95 por ciento. Resultados: Se estudiaron 50 pacientes, los efectos adversos presentados con mayor frecuencia en el primer trimestre fueron alteraciones del ciclo 48 por ciento, mastalgia 46 por ciento, amenorrea 40 por ciento, mareo 40 por ciento, cefalea 40 por ciento, náuseas 30 por ciento, acné 28 por ciento, aumento de peso 26 por ciento y dolor local 10 por ciento. Se observó al final del tercer trimestre reducción de la cefalea, mastalgia y mareo (p<0,05); para el cuarto trimestre las náuseas y las alteraciones del ciclo (p<0,05). El 11,1 por ciento de las pacientes desertaron del método al final del estudio. Se observó que el uso del desogestrel tuvo un valor estadísticamente significativo para el control de la dismenorrea (p<0,05) al final del cuarto trimestre de uso. Conclusión: Los implantes de desogestrel tienen efectos adversos importantes en los primeros meses de uso para disminuir la mayoría de ellos al final del primer año.

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.

Effects of a monophasic oral contraceptives containing 30 ug ethinyl estradial and 150 ug desogestrel on lipid metabolism in Sudanese women

This study was conducted to determine the effects of a monophasic oral contraceptive containing 30[Mmicro]g ethinyl estradiol and 150[micro]g desogestrel [Marvelon] on serum concentration of triacylglycerols, total cholesterol, and lipoprotein cholesterol fractions in 50 Sudanese women aged 18-30 years. Six treatment cycles were compared with the cycle prior to the first treatment cycle [pretreatment cycle]. Serum concentration of the studied lipid parameters increased progressively. Increase in serum concentration of triacylglycerols, high density lipoprotein cholesterol [HDL-C] and very low density lipoprotein cholesterol [VLDL-C] was not statistically significant [P>0.05] after the last treatment cycle, when compared with the pretreatment cycle. Increase in serum concentration of total cholesterol and low density lipoprotein cholesterol [LDL-C] was statistically significant [P<0.05]. HDL-C/LDL-C ratio decreased non significantly after the last treatment cycle. Marvelon showed high effectiveness as a contraceptive agent, exhibited better cycle control. Menstrual complaints were minor. Reported side effects tended to subside by the last treatment cycle

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.

Eficacia y aceptabilidad en mujeres venezolanas de un anticonceptivo oral monofásico que contiene 20 microgramos de etinilestradiol y 150 microgramos de desogestrel / Efficacy and acceptability in Venezuelan females of a oral monophasic contraceptive containing ethynilestradiol 20 micrograms and desogestrel 150 micrograms

Evaluar la eficacia anticonceptiva, control de ciclo, aceptabilidad por parte de la usuaria, cambios en el peso corporal y tensión arterial con el uso de un anticonceptivo oral monofásico que contiene 20 microgramos de etilestradiol y 150 microgramos de desogestrel. Estudio abierto no comparativo multicéntrico donde participaron 122 mujeres proporcionando datos relativos a 600 ciclos. Ocho centros privados localizados en Caracas, Barquisimeto y Mérida. De las 122 mujeres evaluadas durante 600 ciclos, no se presentó embarazo, el control del ciclo tuvo una duración en todos los casos entre 3 a 5 y no huvo cambios estadísticamente significativos con respecto al peso corporal y tensión arterial. Los resultados derivados de este estudio sugieren que la reducción en la dósis de etinilestradiol a 20 microgramos permite todavía una máxima eficacia, buena aceptabilidad y un adecuado control de ciclo

En anticoncepción hormonal oral, ¿más o menos estrógenos? / Hormone oral contraceptives: more or less estrogens?

La disponibilidad de dos dosis de etinil estradiol (20 y 30 mcg) asociado a desogestrel (150 mcg), permite mayor elasticidad en la prescripción. En la experiencia del autor hay indicaciones preferentes para una y otra dosis: La de 20 mcg: a) en adolescentes sin acné; b) en personas delgadas, de menos de 60 Kg; c) en usuarias de busto grande y sangrados abundantes; d) en pacientes obesas que han alcanzado su peso ideal; e) en usuarios de 35 o más años, apróximas a la menopausia y aún en el corto plazo postmenopausia, si son asintomáticas. La de 30 mcg: a) en adolescentes con acné; b) en pacientes con busto pequeño y sangrados cíclicos escasos; c) en usuarias de más de 60 Kg.; d) en las obesas en tratamiento, mientras alcanzan el peso ideal

La combinación desogestrel etinil estradiol y el peso corporal excedido: resultados actuales / Desogestrel-ethynil estradiol combination and overweight: current data

Se revisan los efectos de diversos progestágenos combinados con etinil estradiol sobre el peso corporal. Un nuevo grupo de pacientes obesas sometidas a tratamiento reductor, que además consumían anticonceptivos hormonales combinados (150 mg desogestrel-etinil estradiol, 30 mcg.) fue estudiado en condiciones similares a las del primer grupo (1992), obteniendose resultados similares, muy satisfactorios; bajan de peso hasta alcanzar el peso ideal, comprobándose que el anticonceptivo que utilizan, desogestrel-etinil estradiol, no interfiere con el tratamiento reductor