Plasma Renin in Women Using and not Using Combined Oral Contraceptive

Abstract Backgroud: Recent studies show that women on combined oral contraceptives (COC) present abnormal fasting lipid profile, increased postprandial lipemia, plasma C-reactive protein (CRP) and blood pressure (BP) compared to women not on combined oral contraceptives. Plasma renin is one of the factors responsible for abnormal BP. Objectives: To assess plasma renin levels in women using or not using COC, the correlation between renin and CRP, as well as divergences in lipid profile. Methods: A cross-sectional study with apparently healthy women aged 20 to 30, eutrophic, irregularly active, and with fasting triglycerides < 150 mg/dL. The sample was stratified into two groups: the No Combined Oral Contraceptive Group (NCOCG), comprised of women who did not use any type of hormone contraceptive, and the Combined Oral Contraceptive Group (COCG) comprised of women on low-dose COC for at least one year. After a 12-hour fast, 5 ml of blood was collected for renin dosing and PCR. Data were analyzed by the t-Test and bidirectional Mann-Whitney Test, both with significance < 0.05. Results: We evaluated 44 women equally distributed between the groups, age 23 ± 1.2 years, BMI 21.0 ± 3.2 kg/m2. Median and interquartile deviation of renin in the NCOCG and the COCG were, respectively, 0.5 (0.1-1.0) and 3.0 (2-6) (p < 0.01). A positive correlation between PCR and renin (p < 0.01 and r = 0.68) was found. Conclusion: The plasma renin levels of women using COC were higher, with a strong correlation with CRP.

Elevation of Oxidized Lipoprotein of Low Density in Users of Combined Oral Contraceptives / Elevação da Lipoproteína de Baixa Densidade Oxidada em Usuárias de Contraceptivo Oral Combinado

Abstract Background: The use of combined oral contraceptive (COC) has been related to changes in glycemic, lipid metabolism, increased oxidative stress, and systemic blood pressure, which could suggest a higher oxidation of low-density lipoprotein cholesterol (LDL-cholesterol) in women on use of COC. Objective: To test the hypothesis that there is a difference in the plasma values of oxidized LDL among women who use and do not use COC, as well as to evaluate the correlation between it and the lipid profile and high-sensitivity C-reactive protein (hs-CRP). Methods: Forty-two women with ages between 18 and 35 years old, who were eutrophic, irregularly active, with triglycerides < 150 mg/dL, blood glucose < 100 mg/dL, and who used or did not use COC were selected. These women were allocated in the COC group, formed by 21 women on COC use for at least 1 year; and a control group (CG), consisting of 21 women who had not used any type of hormonal contraceptive for at least 1 year. A significance level of 5% was adopted for statistical analyses. Results: It was observed that GCOC showed higher values of oxidized LDL than the CG, respectively 384 mU/mL versus 283 mU/mL (p < 0.01). A positive correlation between oxidized LDL and LDL-cholesterol (r = 0.3, p < 0.05), with total cholesterol (r = 0.47, p < 0.01) and with triglycerides (r = 0.32, p < 0.03) was observed, and there was no correlation with the hs-CRP. In the categorized analysis of oxidized LDL, 71.4% of GCOC women, and 28.6% of the CG remained above the established cutoff point. Conclusion: Women who use COC have higher plasma levels of oxidized LDL, and there is a positive correlation between oxidized LDL and other lipid variables.

Resumo Fundamento: O uso de contraceptivo oral combinado (COC) tem sido relacionado com alterações no metabolismo glicêmico, lipídico, maior estresse oxidativo e pressão arterial sistêmica, o que poderia sugerir maior oxidação da lipoproteína de baixa densidade colesterol (LDL-colesterol) em mulheres que utilizam COC. Objetivo: Testar a hipótese de que existe diferença nos valores plasmáticos da LDL-oxidada entre mulheres que utilizam e não utilizam COC, bem como avaliar a correlação entre ela e o perfil lipídico e proteína C reativa de alta sensibilidade (PCR-as). Métodos: Foram selecionadas 42 mulheres com idade entre 18 e 35 anos, eutróficas, irregularmente ativas, com triglicerídeos < 150 mg/dL, glicemia < 100 mg/dL e que utilizavam ou não COC. Essas foram alocadas no grupo COC, formado por 21 mulheres em uso COC há pelo menos 1 ano; e grupo controle (GC), composto por 21 mulheres que não utilizavam nenhum tipo de contraceptivo hormonal há pelo menos 1 ano. Adotado um nível de significância de 5% para as análises estatísticas. Resultados: Foi observado que o GCOC apresenta valores mais elevados da LDL-oxidada que o GC, respectivamente 384 mU/mL versus 283 mU/mL (p < 0,01). Também foi observado correlação positiva entre a LDL-oxidada e a LDL-colesterol (r = 0,3, p < 0,05), com o colesterol total (r = 0,47, p < 0,01) e com os triglicerídeos (r = 0,32, p < 0,03), não havendo correlação com a PCR-as. Na análise categorizada da LDL-oxidada, 71,4% das mulheres do GCOC e 28,6% do GC mantiveram-se acima do ponto de corte estabelecido. Conclusão: Mulheres que utilizam COC apresentam valores plasmáticos mais elevados da LDL-oxidada, existindo, correlação positiva entre a LDL-oxidada e outras variáveis lipídicas.

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.

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.

Efficacy of estriol in inhibiting epithelial proliferation in mammary fibroadenoma: randomized clinical trial

CONTEXT AND OBJECTIVE: Mammary fibroadenoma is a disease that affects a large number of women of reproductive age. The aim of this study was to evaluate the proliferative activity of mammary fibroadenoma through expression of Ki-67 and c-myc antigens, following administration of oral contraceptive with or without estriol. DESIGN AND SETTING: Placebo-controlled double-blind randomized clinical trial in the Mastology Sector of the Department of Gynecology, Universidade Federal de São Paulo. METHODS: Thirty-three fibroadenoma patients were studied. Ten women (group 1) took an oral contraceptive constituted by levonorgestrel and ethinyl estradiol together with placebo manufactured in the same capsule for four consecutive cycles with a seven-day interval between them. The other 23 patients (group 2) took the same oral contraceptive together with estriol, which was put into the same capsule and used in the same way as among the group 1 patients. After four cycles, the nodules were surgically removed and sent for immunohistochemical analysis of Ki-67 and c-myc expression. RESULTS: The Ki-67 and c-myc analysis did not reveal any significant differences between the study groups. The values were 9.16 and 10.54 for group 1 and 10.86 and 17.03 for group 2, respectively. There was a tendency towards higher expression of antigens in group 2. CONCLUSION: Our results showed that there was no significant statistical difference in Ki-67 and c-myc expression between our study groups, but only a tendency towards higher expression among users of oral contraceptives containing estriol.

CONTEXTO E OBJETIVO: O fibroadenoma mamário é uma doença que atinge um grande número de mulheres na idade reprodutiva. O objetivo foi avaliar a atividade proliferativa do fibroadenoma mamário, através da expressão do Ki-67 e do c-myc, após a administração de anticoncepcional oral, associado ou não ao estriol. TIPO DE ESTUDO E LOCAL: Ensaio clínico randomizado, duplo-cego, placebo controlado, realizado na Universidade Federal de São Paulo a nível terciário. MÉTODOS: Foram estudadas 33 pacientes portadoras de fibroadenoma, atendidas no setor de Mastologia da Disciplina de Ginecologia da Universidade Federal de São Paulo - Escola Paulista de Medicina (Unifesp-EPM), sendo que 10 mulheres constituíram o grupo 1, e utilizaram anticoncepcional oral composto de levonorgestrel e etinilestradiol, associados a placebo na mesma cápsula por quatro ciclos consecutivos, com intervalo de sete dias entre cada um. As restantes 23 pacientes alocaram-se no grupo 2 e ingeriram, além do anticoncepcional oral descrito acima, um comprimido de estriol, que foi manufaturado na mesma cápsula e foi utilizado da mesma forma que nas pacientes do grupo 1. Ao final dos quatro ciclos, praticou-se a exérese cirúrgica dos nódulos, com posterior envio para análise imunoistoquímica de Ki-67 e c-myc. RESULTADOS: A análise com Ki-67 e c-myc não revelou diferença significante entre os grupos estudados, que foi de 9,16 e 10,54 no grupo 1 e de 10,86 e 17,03 no grupo 2, respectivamente, apesar de ter havido tendência a maior expressão dos marcadores entre as pacientes do grupo 2. CONCLUSÃO: Nossos resultados demonstram não haver diferença estatisticamente significante na expressão de Ki-67 e de c-myc entre os grupos em estudo, apenas uma tendência a sua maior expressão entre as usuárias de anticoncepcional e estriol.

Effect of a low-dose oral contraceptive on venous endothelial function in healthy young women: preliminary results

BACKGROUND: A possible increase in the incidence of venous thromboembolic events has been reported among users of third generation oral contraceptives. The objective of this study was to evaluate the effect of a low dose oral contraceptive (15 æg ethinyl estradiol/60 æg gestodene) on the venous endothelial function of healthy young women. METHODS: Prospective case control study using the dorsal hand vein technique. Venous endothelial function was evaluated at baseline and after 4 months in the oral contraceptive users group (11 women) and in a control group (9 women). After preconstriction of the vein with phenylephrine, dose-response curves for acetylcholine and sodium nitroprusside were constructed. RESULTS: In the contraceptive users group, a reduction occurred in the maximum venodilation response to acetylcholine and sodium nitroprusside after 4 months of oral contraceptive use, but this difference was not statistically significant (P > 0.05). No significant changes were detected in maximum venodilation responses to acetylcholine and sodium nitroprusside at the 4-month time point in the control group. CONCLUSION: This study found no significant impairment of endothelium-dependent or independent venodilation in healthy young women following oral contraceptive use. Further studies are necessary using the same methodology in a larger sample over a longer follow-up period.

Um aumento no risco de tromboembolismo venoso têm sido descrito em usuárias de anticoncepcionais hormonais oral de terceira geração. OBJETIVO: Avaliar o efeito de um anticoncepcional combinado hormonal oral de baixa dose (15 æg etinil estradiol/60 æg gestodeno) na função endotelial venosa de mulheres jovens saudáveis. MÉTODOS: Realizou-se um estudo caso-controle prospectivo em vinte mulheres jovens saudáveis que foram avaliadas pela técnica da complascência venosa. A função endotelial venosa foi avaliada em um momento basal e após 4 meses no grupo das usuárias de anticoncepcional oral (11 mulheres) e em um grupo controle (9 mulheres). Foram construídas curvas dose resposta para acetilcolina e nitroprussiato de sódio após a pré-constrição da veia com fenilefrina. RESULTADOS: No grupo de usuárias de anticoncepcional combinado hormonal oral houve diminuição da venodilatação máxima em resposta a acetilcolina e nitroprussiato de sódio, porém esta mudança não foi estatisticamente significante (p> 0,05). No grupo controle não foram detectadas mudanças significantes na venodilatação máxima, em resposta a acetilcolina e nitroprussiato de sódio no intervalo de 4 meses. CONCLUSÃO: Este estudo não observou redução significante da venodilatação endotélio dependente e independente após os uso de anticoncepcional combinado hormonal oral. Mais estudos são necessários utilizando a mesma metodologia em uma amostra maior e com maior tempo de seguimento.

Use of combined oral contraceptives: retrospective study in Isfahan, Islamic Republic of Iran

We carried out a retrospective cross-sectional study on 500 women in Isfahan who started taking combined oral contraceptives [COCs] during the period 21 March 1995-20 March 1997. The cumulative continuation rate fell from 77% to 12% over 60 months. The most common reason for discontinuation was side-effects. There was a significant correlation between side-effects and cumulative COC continuation rate [P < 0.05]. The lowest rate was seen in women reporting nausea or vomiting. Women who are interested in COCs should receive extensive counselling about the possible side-effects and should be helped to find a method of birth control suited to their temperament and physiology

Glycemic status in women using combined oral contraceptive pill.

This study was undertaken to determine the effects of low-dose combined oral contraceptives(OCs) containing 30 gm Ethinyl estradiol with 150 microg Levonorgestrel on carbohydrate metabolism by a glycaemic variable -- fasting blood glucose level. It is now known that impairment of carbohydrate metabolism is a potential risk factor for cardiovascular disease and other metabolic disorder. Sixty women age between 15-35 years using OCs served as experimental group and thirty age matched hormonal contraceptive non users were selected for control group. Experimental group was again subdivided into OCP (Oral contraceptive pill) users for last one year group, three year group and five year group. The result showed that there were no significant differences on blood glucose level between users and non-users women. It is concluded that the cyclic administration of monophasic low dose OCs did not altered blood glucose levels and there by have no additional adverse impact on women health reaffirming the ongoing oral contraceptive pill distribution program.

Serum zinc status of rural women taking combined OC.

This prospective case-control study was undertaken on 78 women between 15 to 45 years of age from rural area to see alteration of serum zinc due to oral contraceptive (OC) use. Of the subjects, 34 women was taken as controls having no history of taking any form of hormonal contraceptives neither during the time of selection nor during one-year period prior to the study. All of the women in the control group were advised to start consuming oral pill (Sukhi) for 3 consecutive cycles and at the 3(rd) month, 25 women were taken as cases on longitudinal basis. Another 44 women were randomly selected as cases on the basis of using combined oral contraceptives (Sukhi) for 4 months onwards. Subjects were classified as follows on the basis of duration of oral contraceptive use: Group I (n=34) -- controls, Group II (n=25) -- 3 months, Group III (n=17) -- 4 months -- 2 years and Group IV (n=27) -- >2 years. Finally, 103 samples of blood (34 from controls and 69 from oral contraceptives users) were collected for estimation of Serum Zinc (microg/dl) by Atomic Absorption Spectrometry using UNICAM - AA Spectrometer. MeanSD of Serum Zinc significantly reduced in all 3 contraceptive groups in comparison to controls (p<0.001). It was recommended to carry out further study including larger population from rural area to elucidate alteration in serum zinc and other trace elements to correlate with side effects caused by hormonal contraceptive so that attempt could be made to mitigate those.

The combined oral contraceptive pill versus bromocriptine to suppress lactation in puerperium: a randomized double blind study.

A randomised double blind comparative study of 230 HIV infected mothers who had a normal delivery at 37-42 weeks' gestation were divided into two groups; 116 combined pill users and 114 bromocriptine users to suppress lactation. There were 33 cases (28.5%) of combined pills users and 29 cases (25.4%) of bromocriptine users who had breast engorgement without statistical difference. All of them had mild breast engorgement without any treatment except one case (0.9%) in the bromocriptine group had severe breast engorgement with puerperal fever and needed an analgesic drug. There were no side effects of the drugs. This study showed that combined pills were beneficial to suppress lactation in HIV infected mothers to prevent postnatal mother-to-child transmission because of low risk and low cost.

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

Effect of combined oral contraceptives on bone mineral density in pre and postmenopausal women.

A retrospective urban-based cross-sectional study was done in the department of Pharmacology in collaboration with the department of Obs and Gynae of BSSMU, Dhaka, to define any relation between the OCP and BMD in pre and postmenopausal women. A total of 100 closely matched healthy women were selected non-randomly. The age range was 35-55 years. Among them 50 were controls or nonuser and 50 were case or users of OCP. They were further subdivided into pre and postmenopausal groups. Bone density of the 100 women was measured in distal radius and ulna by single photon Absorptiometry Bone Densitometer DTX-100. Statistically significant higher bone mineral density (BMD) was found in oral combined OCP users than non-users, both in pre and postmenopausal women. It can be concluded from this study that the most important non-contraceptive benefit of OCP may be positive effects on bone mass and thus reduced risk of postmenopausal osteoporosis and osteroporotic fracture.

Influence of components of oral contraceptive on lipid metabolism.

Oral contraceptives (OC) have been shown to enhance the risk of atherosclerosis. In the present study we sought to determine which component of the OC (containing 0.067 mg estrogen and 0.667 mg of progestin) counts for alteration in lipids profile. Female rats were administered with 0.067 mg of 17 beta-estradiol and 0.667 mg of norethindron acetate/kg body weight. Estrogen treatment exhibited higher levels of lipids in the serum and tissues. LDL-cholesterol increased by three folds but HDL-cholesterol decreased significantly, while progestin group showed decreased levels of lipids and LDL cholesterol. Elevated hepatic cholesterogenesis was observed as indicated by increased activity of HMG-CoA reductase and elevated incorporation of labelled acetate into liver cholesterol in estrogen group. On the other hand, progestin treatment did not alter the activity of HMG-CoA reductase and the rate of incorporation of labelled acetate into hepatic cholesterol. Hepatic degradation of cholesterol to bile acids however, decreased with estrogen treatment. No considerable changes were observed in hepatic bile acid levels in progestin group. Release of lipoprotein into circulation increased but their clearance from the circulation decreased as revealed by the activity of lipoprotein lipase (LPL) of extrahepatic tissues in estrogen group. With progestin treatment, activity of LPL increased significantly in adipose tissue. Activity of hepatic malic enzyme and glucose 6-phosphate dehydrogenase enhanced considerably in estrogen group, while activities of these enzymes were depressed with progestin administration. Thus results indicate that estrogen component of oral pills counts for major changes in lipid and lipoprotein metabolism favouring the development of atherosclerosis.

Funçäo ovárica durante uso de anticoncepcional oral trifásico, com prolongaçäo do intervalo sem tratamento / Ovarian function during use of a triphasic contraceptive pill, prolonging the treatment free interval

OBJETIVOS: Avaliar se ocorre desenvolvimento folicular e ovulaçao durante uso de anticoncepcional trifásico (AO) (6,5 e 10 drágeas com 30, 40 e 30 mcg de etinilestradiol e 50, 75 e 125 mcg de levonorgestrel), em mulheres que aumentam o intervalo livre entre dois ciclos, de 7 para 9 até 11 dias. MATERIAL E MÉTODOS: Foi realizado um estudo prospectivo, descritivo, randomizado com 9 mulheres voluntárias, no Setor de Reproduçao Humana do CAISM-UNICAMP. As mulheres foram avaliadas segundo o seguinte esquema: um primeiro ciclo menstrual sem uso de AO e um segundo ciclo tomando AO corretamente. O terceiro ciclo, deixando um intervalo sem tratamento de 9, 10 ou 11 dias nos grupos I, II e III respectivamente (três mulheres em cada grupo). O desenvolvimento folicular e a ovulaçao foram monitorizados mediante realizaçao de ecografia transvaginal e dosagens hormonais cada dois ou três dias entre o 8( e o 17( dia do ciclo, além de três amostras para progesterona colhidas entre o dia 15 e 20 do ciclo. RESULTADOS: Nos três grupos houve aumento dos níveis de E2 sérico correlacionando-se com crescimento folicular até diâmetros de 12 a 35 mm, mas somente uma mulher do grupo II mostrou evidências de ruptura folicular, confirmada pela elevaçao da progesterona até 11 ng/ml. CONCLUSOES: O aumento de intervalo livre de pílula entre dois ciclos, acarreta um risco de desenvolvimento folicular e de ovulaçao. Devemos orientar as usuárias que nesses casos, deve-se usar método de barreira juntamente com a pílula, até o final da cartela.

Estudo multicêntrico aberto, de uma preparaçåo monofásica de gestodene e etilinestradiol em concepçåo oral / A multicenter open-label study of monophasic gestodene and ethinylestradiol in oral contraception

A eficácia, o controle de ciclo, a tolerabilidade e a aceitabilidade de um contraceptivo oral monofásico de baixa dosagem contendo gestodene 75 mcg e etinilestradiol 30 mcg, foram avaliados em um estudo prospectivo multicêntrico, nåo comparativo, aberto, de seis ciclos de tratamento. Foram avaliados um total de 1.666 ciclos. Nåo houve ocorrência de gravidez. Aderência ao tratamento foi boa com omissåo de uma ou mais pílulas em somente 3,3 por cento dos ciclos. Durante o estudo, houve uma reduçåo significante da duraçåo dio ciclo e duraçåo e intensidade do fluxo em relaçåo ao pré-tratamento. Somente em 2,34 por cento e 1,14 por cento dos ciclos houve ocorrências de spotting e sangramento intermenstrual, respectivamente. Nåo houve ocorrência de amenorréia. Houve reduçåo significante (p<0,05) de acne, tensåo mamária e dismenorréia durante o tratamento. Reaçöes adversas (náusea, cefaléia e vômito) foram relatadas por 12,98 por cento das pacientes, sendo de leve intensidade e tendência a desaparecer com a continuidade do tratamento. Uma paciente interrompeu o tratamento, por efeito colateral (náusea, pirose e tontura). Nåo houve alteraçöes clinicamente significantes na pressåo arterial, peso corpóreo, bioquímica sangüínea e urinálise

The effect of oral contraceptives on protein metabolism.

The effect on protein and amino acid metabolism of combined oral contraceptives (OC) containing 150 micrograms of laevonorgestrel and 30 micrograms of ethinyl oestradiol was studied in a group of 34 healthy non-lactating women. This was compared to an identical study conducted in another group of 19 subjects who used IUCDs for contraception, and also in two other groups of subjects who were given an additional multivitamin preparation on a daily basis (29 subjects) and on the days when OC was not taken (29 subjects). Assessments were made prior to, and during the third week of the 4th, 7th, and the 13th cycles of OC treatment. Results indicated that the ceruloplasmin and retinol binding protein underwent significant increases with OC usage, while sex hormone binding globulin concentration, on the other hand, remained unaffected. At the same time, a significant reduction of several of the plasma amino acid and plasma albumin concentrations was observed, suggesting that the increase in the visceral and other types of protein concentrations previously noted was due to increased hepatic protein synthesis rather than increased breakdown or excretion as result of OC intake. Interesting biochemical alterations and metabolic effects previously observed may well be related to this altered synthesis and release of proteins and/or protein binders as well as induction of certain metabolic enzymes from the liver.

Seguridad, efectividad y control del ciclo menstrual de una preparación anticonceptiva oral monofásica con 75 mcg de gestodeno y 30 mcg de etinilestradiol / Safety, efficacy and cycle control of an oral monophasic contraceptive formulation containing gestodene 75 mcg de gestodeno y 30 mcg de etinilestradiol

Se estudió una formulación oral monofásica a base de 75 mcg de gestodeno y 30 mcg de etinilestradiol, con el objeto de probar su seguridad, eficacia y control del ciclo menstrual. En el estudio se incluyeron 67 mujeres sanas que acumularon 574 ciclos. Esta formulación mostró ser muy eficaz, ya que con el uso adecuado del método no se presentó ningún embarazo. los efectos secundarios observados fueron iguales o menores a los reportados con otros anticonceptivos hormonales orales. La administración de este nuevo preparado no modificó los parámetros hematológicos, bioquímicos o urinarios de las usuarias. Con respecto al control sobre el sangrado endometrial, las usuarias de mantuvieron dentro de un patrón menstrual considerado como acptable. En conclusión, se trata de un anticonceptivo oral que resultó ser eficaz, bien aceptado y cuyos efectos secundarios son semejantes o menores a los de otros anticonceptivos orales.

Structural changes in human cervical mucus.

The crystallization phenomenon of human cervical mucus was investigated with the help of scanning electron microscope. Changes in the conformation of crystals and ferning patterns were studied on different days of the menstrual cycle in both normally ovulating women and those using oral contraceptives. No crystalline structure was found on day 5 in both categories of women, whereas square crystals were observed on day 21 in normal woman. Nature and type of ferning pattern changes seen from days 11 to 14 in normal women were not seen during this period in women who were on oral contraception, instead a thick, viscous mucus was found during the entire period of the cycle.