Manejo farmacológico del sangrado irregular no menstrual asociado al uso de implantes anticonceptivos subdérmicos / Pharmacological management of irregular non-menstrual bleeding associated with the use of subdermal contraceptive implants

El spottingo sangrado irregular no menstrual es uno de los principales efectos secundarios de los implantes anticonceptivos, situación que se recomienda discutir con la usuaria previo a la colocación, para evitar falsas expectativas o temores que lleven a la extracción temprana del dispositivo. A propósito de una paciente sin antecedentes relevantes que consultó al centro de salud por spotting desde la colocación del implante cuatro meses antes, decidimos revisar la evidencia sobre la efectividad de los distintos esquemas farmacológicos disponibles para el manejo de este evento adverso. Luego de realizar una búsqueda bibliográfica concluimos que, si bien existe sustento para indicar algunos de los esquemas farmacológicos, este es aún débil y son necesarios estudios clínicos adicionales que brinden evidencia sólida sobre qué esquema en particular utilizar, evaluando sus riesgos y beneficios. (AU)

Spotting or irregular non-menstrual bleeding is one of the main side effects of contraceptive implants, a situation that health professionals must discuss with the user prior to its placement in order to avoid false expectations or fears that lead to early removal of the implant. Regarding a patient with no relevant history who consulted the health center due to spotting four months after implant placement, we decided to review the evidence onthe effectiveness on different pharmacological schemes available for the management of this adverse event. After performing a literature search, we concluded that, although there is support for indicating some of the pharmacological schemes, this is still weak, and further clinical studies are needed to provide solid evidence on which particular scheme touse, assessing its risks and benefits. (AU)

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.

Pulmonary embolism in a healthy woman using the oral contraceptives containing desogestrel

Venous thromboembolism is well known as one of the rare but serious adverse effects of combined oral contraceptives (COCs). The COCs with third and fourth generation progestogens were found to have higher risk of venous thrombosis than those with second generation progestogens. We present a case of pulmonary embolism in a 23-year-old nulligravid woman who was using COCs containing the third generation progestogen (desogestrel). At the time of presentation of the adverse effect, she had been using the COCs for 4 months. She had no additional risk factors for thrombosis such as smoking, surgery, tumor as well as genetic factors. This case demonstrates even young women in otherwise good health may be at risk of venous thromboembolism from low-dose formulations of COCs as an over-the-counter drug. We describe this case with a brief review of literatures.

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.

Determination of Optimal Imaging Mode for Ultrasonographic Detection of Subdermal Contraceptive Rods: Comparison of Spatial Compound, Conventional, and Tissue Harmonic Imaging Methods

OBJECTIVE: To determine which mode of ultrasonography (US), among the conventional, spatial compound, and tissue-harmonic methods, exhibits the best performance for the detection of Implanon(R) with respect to generation of posterior acoustic shadowing (PAS). MATERIALS AND METHODS: A total of 21 patients, referred for localization of impalpable Implanon(R), underwent US, using the three modes with default settings (i.e., wide focal zone). Representative transverse images of the rods, according to each mode for all patients, were obtained. The resulting 63 images were reviewed by four observers. The observers provided a confidence score for the presence of PAS, using a five-point scale ranging from 1 (definitely absent) to 5 (definitely present), with scores of 4 or 5 for PAS being considered as detection. The average scores of PAS, obtained from the three different modes for each observer, were compared using one-way repeated measure ANOVA. The detection rates were compared using a weighted least square method. RESULTS: Statistically, the tissue harmonic mode was significantly superior to the other two modes, when comparing the average scores of PAS for all observers (p < 0.00-1). The detection rate was also highest for the tissue harmonic mode (p < 0.001). CONCLUSION: Tissue harmonic mode in uS appears to be the most suitable in detecting subdermal contraceptive implant rods.

Progestógenos: farmacologia e uso clínico / Progestagens: pharmacology and clinical use

Os progestógenos são esteroides que podem ser sintéticos ou naturais. A progesterona é o único progestágeno natural. Os progestógenos sintéticos tentam mimetizar o efeito da progesterona, e são chamados de progestinas. Cada progestina apresenta diferentes propriedades farmacológicas, dependendo da molécula da qual foi originada, usualmente testosterona e progesterona. Pequenas mudanças estruturais nas moléculas originais levam a diferenças consideráveis na atividade de cada uma das progestinas. O objetivo deste trabalho é revisar a origem dos progestógenos, as peculiaridades de cada grupo e seu uso clínico mais comum. As informações já levantadas sobre o efeito das progestinas em patologias importantes e prevalentes, como o câncer de mama e eventos tromboembólicos, também será abordado.

Progestagens are natural or synthetic steroids, and progesterone is the only natural one. Synthetic progestagens, called progestins, were created to mimic the effects of natural progesterone. The progestins have different pharmacological properties depending on the parent molecule, usually testosterone or progesterone, from which they are derived. Very small structural changes in the original molecule may induce considerable differences in the activity of the derivative. The aim of this paper is to review the origin of each progestin, the peculiarities of each group and its most common clinical use. The current knowledge about the effect of progestins on important and prevalent diseases, such as breast cancer and thromboembolic events, will also be addressed.

Drug synergistic antifertility effect of combined administration of low-dose gossypol with steroid hormones in rats / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Our previous studies suggested that low-dose gossypol combined with steroid hormones has a reversible antifertility role in adult male rats, and the course of treatment was shorter than that of either gossypol or steroid hormones alone. This result suggested that low-dose gossypol and steroid hormones have a drug synergistic effect on antifertility. The aim of the study was to find the target organs of the antifertility synergistic effect of the combined regimen.</p><p><b>METHODS</b>Thirty-two adult male rats were divided into four groups randomly: group GH, rats were fed orally with gossypol acetic acid (GA, 12.5 mg×kg(-1)×d(-1)) and desogestrel (DSG, 0.125 mg×kg(-1)×d(-1))/ethinylestradiol (EE, 0.025 mg×kg(-1)×d(-1))/testosterone undecanoate (TU, 100 mg×kg(-1)×d(-1)); group G, a single dose of GA (12.5 mg×kg(-1)×d(-1)) was given; group H, the same dosage of DSG/EE/TU as in group GH were administered; group C, rats were treated with vehicle (1% methyl cellulose) as control. Testes and epididymis were removed at 8 weeks post-treatment for evaluating their weight, volumes, volume fraction, and total volume of testicular tissue structures and the seminiferous tubule diameter using stereological assay. Sperm cell numbers and the motility of epididymal sperm were quantitated by flow cytometry and morphological methods.</p><p><b>RESULTS</b>Compared with group C, spermatogenesis was normal in group G and suppressed in groups H and GH. Similar changes of testicular tissue structures and sperm number were found in groups H and GH. The decreases of epididymal sperm number and motility in group GH were greater than that of the low-dose gossypol or steroid hormones alone group.</p><p><b>CONCLUSIONS</b>The suppression of spermatogenesis was induced by steroid hormones in the combined regimen, and the epididymis was the target organ of low-dose gossypol. Combined use of low-dose gossypol and steroid hormones played a comprehensive antifertility role in their synergistic effect on reducing the number and motility of epididymal sperm.</p>

Desogestrel+ethinylestradiol versus levonorgestrel +ethinyles tradiol Which one has better affect on acne, hirsutism, and weight change

To compare complications of third and second generation oral contraceptive pills [OCPs]. In a randomized clinical trial from October 2007 to October 2008, 100 healthy women of reproductive age referred to Amir Hospital Family Planning Clinic and some heath centers in Semnan, Iran were randomized in 2 equal groups. They received either a third generation OCP [150 micro g desogestrel [DSG] + 30 micro g ethinylestradiol [EE] or a second generation type [150 micro g levonorgestrel [LNG] + 30 micro g EE]. Six months later, changes of weight, acne, and hirsutism severity, as well as serum titers of sex hormone-binding globulin [SHBG] and free testosterone were compared between the 2 groups. Forty-five women were evaluated in the DSG+EE OCP group, and 46 women in the LNG+EE OCP group. The BMI was significantly higher in the second group [p=0.000] after 6 months duration. Likewise, the decrement of acne and hirsutism seventy was significantly higher in the DSG+EE users [p=0.000]. Mean changes of serum free testosterone [f=0.967] and SHBG [f=0.916] were comparable between the 2 groups. In comparison with the LNG+EE OCP, the DSG+EE OCP is a contraceptive pill that significantly decreases the severity of acne and hirsutism, without any significant change in weight

Simultaneous determination of gestodene, etonogestrel and ethinylestradiol in plasma by LC-MS/MS following derivatization / 药学学报

To establish a sensitive and specific method for simultaneous determination of gestodene, etonogestrel and ethinylestradiol in plasma by LC-MS/MS, plasma samples were extracted and derivatized before injection. An ESI ion source was used and operated in the positive ion mode with multiple reaction monitoring (MRM). Norgestrel was chosen as internal standard and performed on a C18 (100 mm x 2.1 mm, 5 microm) column. The concentrations of gestodene, etonogestrel and ethinylestradiol were measured, using step-gradient mobile phase and step-gradient flow rate. The method was validated over the concentration range of 0.1-20 ng x mL(-1) for gestodene and etonogestrel and 0.01-2 ng x mL(-1) for ethinylestradiol, and showed excellent linearity. The intra- and inter-assay accuracy and precision were below 10.0% and recovery was 93.6%-110.9% over the three concentration levels evaluated. The method was applied in pharmacokinetic study of the compound gestodene patch and the compound etonogestrel patch in rabbits. The LC-MS/MS method was selective, accurate and sensitive, especially the LOQ were 100 pg x mL(-1) for gestodene and etonogestrel and 10 pg x mL(-1) for ethinylestradiol. The method was successfully applied in pharmacokinetic study for contraceptives.

Norplant and implanon acceptability by users in Assiut University Hospital

The aim of this study was assess the Norplant and Implanon acceptability by users at Assuit University Hospital. The study was carried out on a convenience sample of 50 women age with range 20 years to over 40 years or more A structured interview questionnaire was designed to collect data related to the field work was performed over a period its five months from January till April 2005 of the same year the majority of the sample were illiterate Duration of marriage 50% of the sample was 11-20 years menstruation were regular in about 68.6% more than half had 4-8 children history of used contraception 21.6% used Norplant as method and the minority used more than one method data related to current contraception duration of uses 37.2 less than one year and 35.2% and 27.4 used form 1-3 years and 4-5 years 29.4% had no side effect but 25.4 had amenorrhea. And 18.4 had metrorrhagia the minority had mixed causes decrease weight metrorrhagia and dizziness in 3.9% was illiterate group 17.6% used Norplant and 11.8% used lUDs in secondary group 3.9% in university group used Norplant and Implanon parity 1-3 times 35.1% and 4-8 times 53% more than 8 times. No significant relationship between parity and used Implanon and Norplant p=0.253. Also highly significant relations between parity and education p=0.000

Avaliação de protocolos para indução de inatividade ovariana em gatas domésticas / Evaluation of protocols for induction of inactivity ovarian in domestic cats

Os índices de prenhez após inseminação artificial em felídeos selvagens não são satisfatórios devido ao variável ambiente endócrino após a estimulação com gonadotropinas. O objetivo deste estudo consistiuem aumentar a taxa de sucesso em programas de inseminação artificial em gatas domésticas (animal modelo). As fêmeas (n=9) foram divididas em três grupos, cada um com três animais, sendo: 1) controle(C), somente 200 UI eCG/ 100 UI hCG ; 2) levonorgestrel oral (L)(0,075 mg) durante 37 dias + eCG/hCG; 3) etonogestrel (E), implante subdérmico durante 37 dias + eCG/hCG. Foram submetidas ao exame laparoscópico 29-39 horas após a administração de hCG para verificação da resposta ovariana e realização de esfregaço vaginal para monitoração da fase do ciclo estral. Foram coletadas amostras de fezes 60 dias antes e 60 dias após o tratamento com gonadotropinas para dosagem hormonal de estrógenos. Os resultados foram avaliados através do Teste ANOVA. Os níveis de significância mostraram que o Grupo E, em contraste com o Grupo C e o Grupo L, apresentou inibição satisfatória das concentrações de estrógenos durante a sua utilização. O grupo L não apresentou inibição ovariana durante o tratamento e diferença significativa em relação ao Grupo C. No exame laparoscópico todas as fêmeas dos grupos C, L e E apresentaram folículos e 77% das fêmeas apresentaram corpo lúteo. Também apresentaram células epiteliais superficiais anucleadas e nucleadas características de estro. Concluiu-se que a utilização de implantes de etonogestrel em gatas domésticas mostrou-se eficaz, possibilitando asua utilização prévia aos programas de inseminação artificial, aspiração folicular e também para a contracepção.

Reproductive success in endangered captive small felids species is veryl ow. Due to great variability in endocrine environment post gonadotropin treatment, after artificial insemination pregnancy rates are very low. Nowadays, ovarian activity controll improves the AI success in many species. In this study, new protocols were compared to improve the fertilization rates in artificial insemination programs in domestic cat. Female domestic cats were divided in three treatments: 1) control (eCG/hCG); 2) levonorgestrel (0.075 mg) orally during 37days + eCG/hCG; 3) etonogestrel subdermal implant during 37days + eCG/hCG: Laparoscopies were done 29-39 hours post hCG treatment to verify ovarian activity. Vaginal swabs were collected at laparoscopic procedures. Fecal samples were colected 60 days before, during and 60 days after the gonadotropin treatment for estradiol assay. Means comparisons were done by ANOVA test. Results demonstrated that etonogestrel (implant) and not oral levonorgestrel successfully suppressed ovarian activity. The levonorgestrel group didnot show ovarian inactivity during the administration, presenting oestradiol peaks and without significative diference comparing to control group. All females presented anuclear and nuclear superficial vaginal epithelial cells at laparoscopies. In conclusion, the etonogestrel implant used in the domestic cat was efficient and can be used previous to gonadotropin protocol in artificial insemination programs, follicular aspiration and contraception

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.

Implanon failure.

A 28-year old woman, P1-0-1-1 presented with 5-month amenorrhea after having had single--rod 68 mg--etonorgestrel contraceptive implant (Implanon) for 18 months. Pregnancy was diagnosed by physical examination and confirmed by ultrasonography. At first, she wanted to have her pregnancy terminated because of a financial problem and anxiety about fetal anomaly as well as pregnancy complication. However, after counseling, she decided to continue her pregnancy and had a normal male infant delivered by cesarean section. This pregnancy is considered as product failure, which is very rare and is the first report in Thailand. Clinical counseling on medical risk of pregnancy and fetal anomaly can reduce the mother's anxiety and assure her to carry on her pregnancy as done in this case.

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.

Effects of biphasic oral contraceptives containing desogestrel (Oilezz) on cycle control facial acne and seborrhea in healthy Thai women.

OBJECTIVE: To demonstrate the effects of a new biphasic oral contraceptive (Oilezz) on cycle control as well as mild to moderate acne and facial seborrhea of healthy fertile Thai women. MATERIAL AND METHOD: The trial is a prospective, open, non-comparative, single center study. Fifty healthy, fertile Thai women with mild to moderate facial acne were recruited to study a specific drug (Oilezz) for 6 months. RESULTS: At the beginning, 66% of the subjects had mild acne and 34% had moderate acne. Significant improvements in facial seborrhea grades (as indicated by Sebutape assessments) were found after the first cycle. These improvements increased steadily and were much larger after the sixth cycle. There were no statistically significant changes in body weight or blood pressure during the study. No serious adverse events were reported. There were no mood changes, migraine, rash, abdominal discomfort, malaise, nausea and decrease in libido during the study period The premenstrual symptoms at initiation were 21 cases (42%). The symptoms were 4 (8%) with headache, 8 (16%) with breast tenderness, 5 (10%) with dysmenorrhea and one (2%) with bleeding irregularity. These symptoms were improved in the third and the sixth cycles. The percentage of women with spotting or bleeding increased after first cycle, compared with baseline and gradually decreased during subsequent cycles. After the sixth cycle of treatment, all subjects had improvement of acne. 80% of cases recovered from acne and there were only 20% had mild acne. CONCLUSION: Facial seborrhea and acne improved significantly with Oilezz. It is good to control cycle without change in body weight and blood pressure. Therefore, Oilezz can be used for treatment of seborrhea and acne and as a contraceptive.

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.