Manejo das irregularidades menstruais secundárias ao uso de contraceptivos ­ análise das recomendações atuais / Management of menstrual irregularities secondary to contraceptive use ­ analysis of current recommendations

As irregularidades menstruais representam uma série de desordens na quantida- de, duração, frequência ou regularidade do sangramento uterino. Entre suas cau- sas destaca-se o sangramento secundário ao uso de anticoncepcionais, uma razão frequente de descontinuidade dos contraceptivos, podendo aumentar as taxas de gestações não planejadas. Boa parte dos contraceptivos pode levar a mudanças no padrão de sangramento uterino, e a abordagem inicial do sangramentos irregula- res inclui a avaliação de outras possíveis causas, o reforço do uso correto da medi- cação, a tranquilização da paciente quanto à benignidade do quadro e à tendência a melhora com a continuidade do uso. Os anti-inflamatórios podem ser usados como estratégia inicial, e, não havendo resposta satisfatória, há alternativas espe- cíficas para cada método. Este trabalho visa identificar as recomendações atuais sobre o manejo do sangramento anormal decorrente de contraceptivos, por meio de revisão narrativa de estudos publicados sobre o tema nos últimos vinte anos.

Abnormal uterine bleeding represents a series of disorders in the amount, du- ration, frequency and or regularity of uterine bleeding. Among its causes, uterine bleeding secondary to the use of contraceptives stands out as a frequent reason for contraceptive discontinuity, which could lead to unplanned pregnancies. Most contraceptives can cause changes in the pattern of uterine bleeding, and the ini- tial approach of the abnormal bleeding includes assessing other possible cau- ses, reinforcing the correct use of medication, and reassuring the patient about the benignity of the condition and the tendency to improve with the continuity of the treatment. Anti-inflammatory drugs can be used as an initial strategy, and, if there is no satisfactory answer, there are specific alternatives for each contracep- tive method. This work aims to identify them current recommendations on the management of abnormal bleeding resulting from contraceptives use, through a narrative review of studies published on the subject in the last twenty years.

Menstrual cycle disturbances after COVID-19 vaccination.

INTRODUCTION: After COVID-19 vaccination, women of reproductive age reported changes in their menstrual cycle. MATERIALS AND METHODS: A retrospective study was carried out after a survey on social networks that included women aged 18-41 years with normal cycles according to International Federation of Gynecology and Obstetrics and who were vaccinated (complete schedule for two doses, except J&J/Janssen or incomplete with a single dose). Women with following conditions were excluded: pregnant or lactating women; history of diseases that cause menstrual irregularities or early menopause: anorexia, bulimia, polycystic ovary syndrome, hypothyroidism, obesity, or low weight; hysterectomized or oophorectomized patients; and high performance athletes. RESULTS: Overall, 950 women completed the survey between July and September 2021. In total, 408 women met the inclusion criteria, and 184 reported the following characteristics: frequency (normal 43.47%, infrequent 25%, and frequent 31.53%), regularity (regular 51.08%, irregular 42.93%, and absent/amenorrhea 5.97%), duration (normal 65.21%, prolonged 26.08%, absent/amenorrhea 8.69%), and volume (heavy 41.84%, light 20.65%, and absent/amenorrhea 6.52%). CONCLUSIONS: SARS-CoV-2 infection and COVID-19 vaccination can influence the menstrual cycle and cause alterations.

The influence of the levonorgestrel-releasing intrauterine system position on bleeding patterns in reproductive age women.

OBJECTIVE: To determine whether users of the non-fundal levonorgestrel-releasing intrauterine system (LNG-IUS) present with unfavorable bleeding patterns more frequently than fundal LNG-IUS users. METHODS: A prospective cohort was conducted from June, 2016 to January, 2018 involving women aged 18-45 years who wished to use the LNG-IUS as contraception and had no contraindications, endometrial polyps, submucosal myomas, irregular menstrual cycle, or anticoagulant use. Two study groups comprised women using fundal insertion and non-fundal insertion LNG-IUS. Bleeding was evaluated using a diary and pictogram chart. RESULTS: Of the 92 women who participated in the study, those with non-fundal LNG-IUS insertion sustained bleeding at rates greater than 83% (31) in the first 3 months of use, and 58% (14) at 6 months, versus 51% (22) at 3 months and 33% (19) at 6 months in those with fundal insertion (P=0.002 at 3 months; P=0.037 at 6 months). Blood loss in the non-fundal LNG-IUS group was higher than in the fundal LNG-IUS group according to pictograms drawn by participants. CONCLUSION: Women with non-fundal LNG-IUS placement had a higher frequency of sustained bleeding and blood loss volume according to self-reported charts than those with fundal LNG-IUS placement.

Relationship between user satisfaction with the levonorgestrel-releasing intrauterine system and bleeding patterns.

AIM: Satisfaction with a contraceptive method constitutes an important factor in its acceptance and long-term use. The objective of this study was to assess the relationship between user satisfaction with the 20-µg/day levonorgestrel-releasing intrauterine system (LNG-IUS) and the bleeding patterns reported at two different time-points during follow-up. METHODS: A total of 251 LNG-IUS users aged 18-45 years were invited to answer a questionnaire on their return to the clinic for a routine follow-up visit and again 1 year later. Data were collected face-to-face. RESULTS: Twenty women discontinued prematurely; therefore, the analysis was performed on 231 women. Most users were either highly satisfied (66.6% and 66.2% at the first and second interviews, respectively) or satisfied (26.4% and 26.4% at the first and second interviews, respectively) with the LNG-IUS. Satisfaction was related to amenorrhea (P < 0.001) and duration of use (P < 0.001). Prolonged bleeding and spotting were the main causes of dissatisfaction with the device. CONCLUSION: Most LNG-IUS users in this sample were satisfied with the device. The only two factors associated with satisfaction were amenorrhea and duration of use, while prolonged bleeding and spotting were the main causes of dissatisfaction. These findings could be useful for health-care professionals and policy-makers when developing information material for women. The study provides insight into the profile of satisfied LNG-IUS users; however, this information is not suitable for counseling women who are considering using an LNG-IUS.

[Human mercury exposure and irregular menstrual cycles in relation to artisanal gold mining in Colombia]. / Irregularidad menstrual y exposición a mercurio en la minería artesanal del oro en Colombia.

INTRODUCTION: Artisanal mining commonly extracts gold with an amalgamation process that uses mercury. The reproductive effects from exposure to elemental mercury used in gold mining have not been sufficiently studied. OBJECTIVE: To evaluate the effect of the exposure to elemental mercury used in gold mining on menstrual cycle regularity and the occurrence of miscarriages in Colombia. MATERIALS AND METHODS: An analytical cross-sectional study was conducted. The participants were female residents of gold mining districts, with a history of exposure to elemental mercury. Menstrual regularity and the occurrence of miscarriages were compared between these women and an unexposed group. Exposure and outcome variables were registered based on a questionnaire which was evaluated for its test-retest reproducibility. Prevalence rates were calculated using a binomial model and goodness-of-fit was evaluated. RESULTS: A total of 72 women exposed to mercury and 121 unexposed women participated. The average time of exposure to mercury among exposed women was 19.58 ± 9.53 years. The adjusted prevalence of irregular menstruation over the last six months was higher in the group of women chronically exposed to mercury vapors (PR=1.59, 95% CI 0.93-2.73), while there was no difference in the proportion of women with a history of miscarriages. CONCLUSIONS: Exposure to elemental mercury used in artisanal gold mining may be associated with a higher prevalence of irregular menstrual cycles but not with the occurrence of miscarriage.

Irregularidad menstrual y exposición a mercurio en la minería artesanal del oro en Colombia / Human mercury exposure and irregular menstrual cycles in relation to artisanal gold mining in Colombia

Introducción. El proceso de extracción del oro por amalgamación con mercurio es común en la minería artesanal. Los efectos sobre la reproducción de la exposición al mercurio elemental en el contexto de la minería del oro, no han sido suficientemente estudiados. Objetivo. Evaluar el efecto de la exposición al mercurio elemental durante la minería del oro, sobre la regularidad del ciclo menstrual y la presentación de abortos en Colombia. Materiales y métodos. Se hizo un estudio analítico de corte transversal. Las participantes residían en distritos de minería de oro con historia de exposición al mercurio elemental y se las comparó con un grupo de mujeres no expuestas, en cuanto a la regularidad del ciclo menstrual y la ocurrencia de abortos. Para el registro de las variables de exposición y resultado, se usó un cuestionario cuya reproducibilidad prueba-reprueba fue evaluada. Se calcularon las razones de prevalencia mediante un modelo binomial y se evaluó la bondad de ajuste. Resultados. Participaron 72 mujeres expuestas y 121 mujeres no expuestas al mercurio. Entre las mujeres expuestas, el tiempo promedio de exposición al mercurio fue de 19,58 ± 9,53 años. La prevalencia ajustada de menstruación irregular en los últimos seis meses, fue mayor en el grupo de mujeres expuestas crónicamente a vapores de mercurio (razón de prevalencia, RP=1,59, IC 95% 0,93-2,73), pero la proporción de mujeres con historia de abortos no fue diferente. Conclusiones. La exposición al mercurio elemental durante el proceso artesanal de la minería del oro podría estar asociada con una mayor prevalencia de irregularidad del ciclo menstrual, pero no con la presentación de abortos.

Introduction: Artisanal mining commonly extracts gold with an amalgamation process that uses mercury. The reproductive effects from exposure to elemental mercury used in gold mining have not been sufficiently studied. Objective: To evaluate the effect of the exposure to elemental mercury used in gold mining on menstrual cycle regularity and the occurrence of miscarriages in Colombia. Materials and methods: An analytical cross-sectional study was conducted. The participants were female residents of gold mining districts, with a history of exposure to elemental mercury. Menstrual regularity and the occurrence of miscarriages were compared between these women and an unexposed group. Exposure and outcome variables were registered based on a questionnaire which was evaluated for its test-retest reproducibility. Prevalence rates were calculated using a binomial model and goodness-of-fit was evaluated. Results: A total of 72 women exposed to mercury and 121 unexposed women participated. The average time of exposure to mercury among exposed women was 19.58 ± 9.53 years. The adjusted prevalence of irregular menstruation over the last six months was higher in the group of women chronically exposed to mercury vapors (PR=1.59, 95% CI 0.93-2.73), while there was no difference in the proportion of women with a history of miscarriages. Conclusions: Exposure to elemental mercury used in artisanal gold mining may be associated with a higher prevalence of irregular menstrual cycles but not with the occurrence of miscarriage.

Menstrual disturbances in systemic lupus erythematosus patients using immunossuppressants.

INTRODUCTION: Systemic lupus erythematosus (SLE) is an autoimmune disease that affects fertile-age women and of which treatment includes immunosuppressive agents that can affect the gonads. OBJECTIVE: To evaluate the frequency of menstrual alterations in lupus patient treated with immunosuppressive agents (ISA). PATIENTS AND METHODS: A total of 87 patients, aged < 40 years, were studied. The patients were followed by outpatient management and the treatment used was verified. Only organic causes of menstrual alterations were excluded from the study. The menstrual alterations were correlated with the type and time of use of different ISA. RESULTS: Age varied from 14 to 38 years, with a mean age of 28.01 ± 5.81 years; the mean age at menarche was 13.12 ± 1.77 years and the diagnosis of SLE was at 21.40 ± 5.75 years. Corticoids were used as single therapy by 63.2% of them, for a mean time of 6.11 ± 5.14 years and the use of other immunosuppressive agents occurred with a mean time of 5.60 ± 3.59 years. Menstrual alterations occurred in 37.9% and amenorrhea in 11.5%. There was an association between menstrual alterations with the use of ISA (P = 0.034). CONCLUSION: The frequency of menstrual alterations was higher than that found in the general population, similar to what was observed in other publications on lupus treatment. The higher frequency of menstrual alterations in these patients was significantly associated with the use of ISA. The results justify caution when prescribing these medications,research indication and the use of techniques for ovarian preservation means.

Alterações menstruais em pacientes com lúpus eritematoso sistêmico sob uso de imunossupressores / Menstrual disturbances in systemic lupus erythematosus patients using immunossuppressants

INTRODUÇÃO: O lúpus eritematoso sistêmico (LES) é uma doença autoimune que afeta mulheres em idade fértil. Em seu tratamento são utilizados imunossupressores que podem afetar as gônadas. OBJETIVO: Avaliar a frequência de alterações menstruais de pacientes lúpicas tratadas com imunossupressores. MÉTODOS: Foram estudadas 87 pacientes, com idade inferior a 40 anos, com LES em seguimento ambulatorial e verificado o esquema terapêutico utilizado. Excluiu-se do estudo outras causas orgânicas de alteração menstrual. Foi feita correlação de alterações menstruais com o tipo e o tempo de uso dos diferentes imunossupressores. RESULTADOS: A idade variou de 14 a 38 anos, com média de idade 28,01 ± 5,81 anos; a média de idade da menarca foi de 13,12 ± 1,77 anos e o diagnóstico de lúpus 21,40 ± 5,75 anos. O corticoide estava em uso de forma individual por 63,2 por cento, com média de tempo de 6,11 ± 5,14 anos e o uso de outros imunossupressores ocorreu com média de tempo de 5,60 ± 3,59 anos. Alterações menstruais ocorreram em 37,9 por cento e amenorreia em 11,5 por cento. Houve associação das alterações menstruais com o uso dos imunossupressores (IS) (P = 0,034). CONCLUSÃO: A frequência de alterações menstruais foi superior a encontrada na população em geral, semelhante ao observado em outras publicações sobre lúpus em tratamento. A maior frequência de alterações menstruais nessas pacientes foi significativamente associada ao uso de Imunesupressores. O resultado justifica a prudência no uso destes medicamentos, a orientação para pesquisa e uso de técnicas de meios de preservação dos ovários.

INTRODUCTION: Systemic lupus erythematosus (SLE) is an autoimmune disease that affects fertile-age women and of which treatment includes immunosuppressive agents that can affect the gonads. OBJECTIVE: To evaluate the frequency of menstrual alterations in lupus patient treated with immunosuppressive agents (ISA). PATIENTS AND METHODS: A totalof 87 patients, aged < 40 years, were studied. The patients were followed by outpatient management and the treatment used was verified. Only organic causes of menstrual alterations were excluded from the study. The menstrual alterationswere correlated with the type and time of use of different ISA. RESULTS: Age varied from 14 to 38 years, with a mean age of 28.01 ± 5.81 years; the mean age at menarche was 13.12 ± 1.77 years and the diagnosis of SLE was at 21.40 ±5.75 years. Corticoids were used as single therapy by 63.2 percent of them, for a mean time of 6.11 ± 5.14 years and the use of other immunosuppressive agents occurred with a mean time of 5.60 ± 3.59 years. Menstrual alterations occurred in 37.9 percent and amenorrhea in 11.5 percent. There was an association between menstrual alterations with the use of ISA (P = 0.034). CONCLUSION: The frequency of menstrual alterations was higher than that found in the general population, similar to what was observed in other publications on lupus treatment. The higher frequency of menstrual alterations in thesepatients was significantly associated with the use of ISA. The results justify caution when prescribing these medications,research indication and the use of techniques for ovarian preservation means.

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

Extended regimens of the vaginal contraceptive ring: cycle control.

BACKGROUND: Oral contraceptives used for extended periods of time have been extensively studied because of their potential benefits; however, there have been few publications on extended regimen of vaginal rings. The aim of this study was to compare the bleeding patterns of women using extended regimens of the vaginal ring or oral contraceptives. STUDY DESIGN: Prospective cohort involving 150 women: 75 used vaginal rings that release 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily, and 75 took oral contraceptives containing ethinyl estradiol 0.3 mcg and desogestrel 150 mcg. Both groups used their respective contraceptive method over continuous periods of 84 days, followed by a 7-day pause, during 1 year. RESULTS: The total number of scheduled bleeding and spotting days decreased significantly during the 1-year period of the study for both methods (p=.001), and this decrease was significantly higher for oral contraceptive users. Similarly, during the study period, there was a significant reduction in the total number of unscheduled bleeding and spotting days for both methods (p=.01), but this decrease was significantly higher among vaginal ring users (p=.003). CONCLUSION: Vaginal ring used on an extended regimen is a contraceptive method that offers good cycle control.

Insertion and 3-year follow-up experience of 372 etonogestrel subdermal contraceptive implants by family physicians in Granada, Spain.

BACKGROUND: User profile, continuation rate, reasons for discontinuation, problems during insertion and removal, and effectiveness of an etonogestrel subdermal contraceptive implant (ESCI) were assessed. STUDY DESIGN: A follow-up of 372 women 3 years after insertion of an ESCI performed by family physicians in Granada, Spain, by means of consultations, examination of medical records and telephone interviews. RESULTS: Data were available for 356 (95.7%) women. The average age was 27.2 years, and 159 (42.7%) were nulliparous. Continuation rates were 91.0% at 1 year, 74.7% at 2 years and 65.1% at 2 years and 9 months. The main reasons for discontinuation were excessive bleeding (44, 12.4%), wish to become pregnant (44, 12.4%) and side effects not related to menstruation (21, 5.9%). However, 141 (39.6%) received a second implant when the first one expired. No pregnancy occurred in 893.4 women-years. CONCLUSIONS: Family physicians can achieve excellent results with the ESCI. It should be included in the range of contraceptives offered by primary care physicians.

Bleeding patterns of adolescents using a combination contraceptive injection for 1 year.

PURPOSE: This prospective observational study evaluated the bleeding patterns of adolescents receiving a monthly injectable contraceptive containing norethisterone enanthate 50 mg plus estradiol valerate 5 mg. MATERIALS AND METHODS: The study enrolled 73 volunteers aged between 14 and 19 years; of these patients, 38 (52%) recorded their menstrual cycles during 1 year. RESULTS: After 1 year of using the contraceptive, most of the 38 women (71.1%) had adequate menstrual patterns (two to four bleeding episodes; none lasting 10 days or longer; with a range of bleeding-free intervals not exceeding 17 days), 23.7% reported prolonged bleeding episodes, 2.6% had irregular bleeding and 2.6% had amenorrhea. Only 1 of the 38 teenagers is known to have discontinued the method due to bleeding. Among these 38 adolescents, dissatisfaction with bleeding patterns was not a frequent reason given for discontinuation of the monthly injectable contraceptive.

Menstrual pattern and lipid profiles during use of medroxyprogesterone acetate and estradiol cypionate and NET-EN (200 mg) as contraceptive injections.

The objectives of this study were to compare effects of medroxyprogesterone acetate 25 mg + estradiol cypionate 5 mg (Cyclofem) and norethisterone enanthate (NET-EN) upon the menstrual pattern and determine changes in lipoprotein parameters after 12 months of use. One-hundred females were included and 87 (45 with Cyclofem and 42 with NET-EN) women completing 12 months were evaluated. Menstrual changes were the leading complaint among users. At the end of 12 months, 20/45 (44.4%) and 18/41 (43.9%) Cyclofem and NET-EN users, respectively, had normal menstrual pattern. Irregular and infrequent bleeding were the two most important changes that occurred. The discontinuation rate at 12 months due to menstrual disturbances did not show any significant differences between the two preparations, but showed lower incidence compared to other studies. Total cholesterol, high-density, low-density and very low-density lipoprotein cholesterol and triglyceride levels decreased at 12 months in both groups and these changes were statistically significant.

Two-year performance of a Nestorone-releasing contraceptive implant: a three-center study of 300 women.

A 2-year trial of a single Nestorone (NES) rod implant was conducted at three Latin American centers, each enrolling 100 women. We studied the safety, effectiveness and acceptability of this progestin-releasing contraceptive implant. Three pregnancies occurred, the last at 18 months of use. Because no pregnancies were expected in the first 18 months, the trial was halted. At that time, 224 women had completed at least 18 months of use, and 99 women had used the implant for more than 24 months. Few participants used adjunctive contraception between the time the study was halted and the time they had their implant removed. No additional pregnancies occurred before the removal of the last implant. The 2-year cumulative pregnancy rate was 1.7 per 100 with a Pearl index of 0.6 per 100 for the 2-year period. The 1-year and 2-year continuation rates were 80.5 and 66.7 per 100, respectively. Menstrual and medical disturbances were the principal reasons for discontinuation, followed by planned pregnancy. Headache and weight gain frequently led to discontinuation. The NES implant had little important effect on most clinical chemistry and lipid parameters. Over the study course, the mean change in hemoglobin was <1%. Slight modification of the design of this single 2-year implant, restoring features previously examined in clinical trials, is likely to improve its effectiveness. A single NES implant appears to provide acceptable contraception for women.

Percepçäo do sangramento mensal entre usuárias de contraceptivos hormonais orais combinados / Perception of monthly bleeding between hormonal contraceptive users

Avaliar a percepçäo de usuárias de contraceptivos hormonais orais combinados (COCs) acerca do sangramento de privaçäo durante o uso da pílula. Estabelecer o percentual de mulheres que utilizam pílulas sem pausa, incluindo as justificativas para tanto, além da preferência quanto ao padräo de sangramento durante o uso de contraceptivos orais. Foram estudadas 231 mulheres, usuárias de COCs, com idade média de 27,4 ñ 6,9 anos, separadas em 3 grupos: pacientes, médicas e estudantes de medicina. As participantes responderam a questionário pré-estabelecido, contendo questöes sobre a necessidade ou näo de sangramento durante a pausa contraceptiva, incluindo as razöes que justificassem o sangramento mensal, além da possibilidade de uso de contraceptivos sem pausa e, ainda, sobre a periodicidade ideal do sangramento na vigência do uso de COC. O sangramento durante a pausa contraceptiva foi considerado necessário por 58,4 por cento das mulheres entrevistadas, com tendência decrescente entre pacientes (68,8 por cento), estudantes (50 por cento) e médicas (29 por cento), com significância estatística ao se compararem pacientes e médicas (OR=5,4; IC 95 por cento=2,14-13,92). A principal justificativa para o sangramento mensal foi a tentativa de se aproximar do natural, sem diferença entre os grupos. O uso sem pausa de contraceptivos foi referido por 36 por cento da amostra, sendo o maior percentual observado entre as médicas (67,8 por cento), também com diferença significativa em relaçäo ao grupo de pacientes. Ao se questionar sobre o padräo de sangramento ideal na vigência do uso de COC, 61,5 por cento das mulheres entrevistadas preferiram ter o sangramento a cada 3, 6, 12 meses ou mesmo nunca; 38,5 por cento preferiram o sangramento mensal. Pode-se observar a influência do conhecimento sobre os COCs como fator preponderante na percepçäo do sangramento mensal durante o uso da pílula. Aproximadamente um terço das pacientes estudadas já utilizaram pílulas sem pausa na tentativa de suprimir o sangramento mensal. Ainda, a maior parte das mulheres avaliadas näo preferiu o sangramento mensal durante o uso do contraceptivo.

Effect of counseling to improve compliance in Mexican women receiving depot-medroxyprogesterone acetate.

This study purported to determine the effect of pretreatment counseling upon discontinuation of 150 mg depot-medroxyprogesterone acetate (Depo-Provera) given for contraception. A total of 350 Mexican women participated: 175 received detailed structured pretreatment counseling about the hormonal effects of the injectable vs. routine counseling upon duration of use and efficacy of the method. Study termination rates were significantly lower in the structured counseling group than in the control group. Cumulative life table discontinuation rates were 17% (30/175) and 43.4% (76/175), respectively (p <0.05). The most common reasons for terminating DMPA were menstrual changes (8.6 and 32% for counseling and control group, respectively). The findings suggest that pretreatment counseling on expected side effects increases the continuation rates of DMPA users.

Current status of injectable hormonal contraception, with special reference to the monthly method.

Injectable contraceptives are a valid option in every family planning program. Contraceptives which are administered every 2 or 3 months, containing only progestogen agents (DepoProvera, Noristerat) have proven efficacious and do not show long-term safety problems. They differ from other contraceptives in their long lasting action and by not presenting the contraindications of the estrogens. Their most prominent side-effect is the irregularity of cyclic bleeding. Although bleeding irregularities are not life threatening, many users stop the treatment for that reason. Monthly contraceptives comprising progestogens and estrogens, maintain or improve the high efficacy of the earlier forms and have the added benefit of allowing bleeding to resemble the physiologic one. This increases acceptability and the continuation rate. There is no long-term inconvenience. At this point, the greatest experience is with the formulation known as Topasel or Perlutal. Other formulations (Cyclofem, Mesigyna) are beginning to be commercialized and their characteristics must still be confirmed through daily use. Indications, contraindications, precautions and warnings for the use of monthly injectable contraceptives are basically identical to those of the combined oral contraceptives, as are the side-effects. Efficacy, though, proves to be superior, which can be correlated to a simpler method of use and less risk of error when using it. Main motivation factors are: efficacy, simplicity in usage, reversibility and confidentiality.

Clinical performance of a new two-rod levonorgestrel contraceptive implant: a three-year randomized study with Norplant implants as controls.

In a randomized three-year clinical trial at seven clinics, the performance of levonorgestrel rod (LNG ROD) implants used by 600 women was compared with that of soft tubing NORPLANT implants used by 598 women. No pregnancies occurred in either group of women and, accordingly, body weight did not affect the efficacy of either type of implant. There were neither statistically significant nor important differences in termination rates for any reason over the three years. Complaint and illness rates during use of either of the two implant types were statistically indistinguishable and were attributable to the same set of conditions. Seventy-one per 100 of the women using each implant regimen continued to the three-year point, for an average annual continuation rate of 89 per 100. Removals of LNG ROD implants were accomplished in about half the time required for removal of Norplant capsule implants (p < 0.001).

Introductory study of the once-a-month, injectable contraceptive Cyclofem in Brazil, Chile, Colombia, and Peru.

An introductory trial with the injectable contraceptive Cyclofem was carried out in Brazil, Chile, Colombia, and Peru, with participation by 3,183 women. Women were followed-up for up to 2 years of use and the data were evaluated by life table analysis. A total of 29,676 women-months were accumulated for up to 2 years. No pregnancies were observed in the 2 years. The discontinuation rates for amenorrhea in the first year ranged from 3.4 in Brazil to 8.1 in Colombia, and for menstrual disturbances from 5.1 in Chile to 9.2 in Brazil. The discontinuation rates for other medical reasons ranged from 7.8 in Brazil to 26.3 in Colombia, and for personal reasons from 17.2 in Chile to 23.5 in Brazil. Continuation rates ranged from 42.3 in Colombia to 52 in Chile. In the second year of observation the rates of discontinuation were lower than those observed in the first year, with the exception of personal reasons in Brazil, which were the same as those observed in the first year. Continuation rates ranged from 19.4 in Brazil to 36.8 in Chile. The comparison of reasons for discontinuation in selected clinics showed that the rate for amenorrhea in one clinic in Chile was more than three times that in others and in Peru was seven times more in one clinic than in another. Regarding menstrual disturbances, in Peru one clinic presented a rate three times higher than the others. The main reasons for discontinuation due to other medical reasons were headache and weight gain. In conclusion, Cyclofem presented a high contraceptive efficacy and an acceptable rate of continuation and discontinuation for up to 2 years in the four countries.

PIP: The performance of the monthly injectable contraceptive, Cyclofem, was evaluated in an introductory trial involving 3183 women recruited from family planning centers in Brazil, Chile, Colombia, and Peru. A total of 29,676 women-months of use were accumulated during up to 2 years of follow-up. No pregnancies occurred during the study period. Discontinuation rates per 100 women in the first year ranged from 3.4 in Brazil to 8.1 in Colombia for amenorrhea and from 5.1 in Chile to 9.2 in Brazil for menstrual disturbances. The discontinuation rate for other medical reasons (primarily headache, weight gain, and acne) ranged from 7.8 in Brazil to 26.3 in Colombia and for personal reasons from 17.2 in Chile to 23.5 in Brazil. First-year continuation rates ranged from 42.3 in Colombia to 52.0 in Chile. In the second year of use, continuation rates ranged from 19.4 in Brazil to 36.8 in Chile. Upon receiving these results, national regulatory authorities in the 4 participating countries approved Cyclofem registration. Acceptance of injectable contraception, which currently entails administration of the method by a service provider and travel to a clinic, could be improved in developing countries by training in self-administration.