RESUMO
Data from a large, international, multicenter, randomized trial were analyzed to compare the acceptability of two nonoxynol-9 spermicide preparations. Women who wished to use a spermicide for contraception were randomly assigned to use either a foaming tablet (n = 383) or a nonoxynol-9 film (n = 382) for 28 weeks as their only method of contraception. Participants completed questionnaires about acceptability of the assigned product 4 weeks after admission and at discontinuation. Women in both groups had very favorable opinions of the spermicide. The proportion of women who said that they liked their assigned product very much was 50% in the tablet group and 55% in the film group. Significantly more women in the film group rated the spermicide difficult to insert and stated that the product stuck to the finger during insertion. More women in the tablet group said that the product was messy and that, at least once, it did not dissolve. In both groups, liking the product was significantly associated with consistency of use, but not with subsequent pregnancy. Participants' male partners had little influence on participants' opinions about, or use of, the spermicides. Although previous analyses showed that both spermicides are associated with high pregnancy rates, they are both highly acceptable to most women.
PIP: This study compares the acceptability of two nonoxynol-9 spermicide preparations in Mexico, Ecuador, Guatemala, Ghana and the US. A total of 765 women (383 using a foaming tablet and 382 using nonoxynol-9 film for 28 weeks) were enrolled. Participants completed a questionnaire about acceptability of the assigned product, 4 weeks after admission and at discontinuation. Result of the trial revealed that women in both groups had very favorable opinions of the spermicide. The proportion of women who said that they liked their assigned product very much was 50% in the tablet group and 55% in the film group. Significantly more women in the film group rated the spermicide difficult to insert and stated that the product stuck to the finger during insertion. More women in the tablet group expressed that the product was messy and that, at least once, it did not dissolve. In both groups, liking the product was significantly associated with consistency of use, but not with subsequent pregnancy. Participants' male partners had little influence on participants' opinions about, or use of, the spermicides. Although previous analysis showed that both spermicides were associated with high pregnancy rates, they were both highly acceptable to most women.
Assuntos
Nonoxinol/administração & dosagem , Satisfação do Paciente , Espermicidas/administração & dosagem , Adolescente , Adulto , Equador , Escolaridade , Feminino , Gana , Guatemala , Humanos , Masculino , Estado Civil , México , Inquéritos e Questionários , Comprimidos , Estados UnidosRESUMO
This study measured short-term female condom acceptability among 51 female sex workers in San José, Costa Rica. Each woman was trained in use of the female condom and was asked to use the device if clients refused to use male condoms during a 2-week study period (male condoms were also distributed). Two follow-up visits with short interviews were scheduled, including questions on general reaction to the female condom by the participants and their clients, ease and comfort of use, and preferences for male or female devices. At the first follow-up visit, 51% of the women reported they "liked the female condom very much" and 45% reported they "liked it somewhat." Similar results were reported after the second follow-up phase. Sixty-seven percent of the participants preferred the female condom over the male condom, and, according to the the women, over half of their clients liked the female condom "very much" or "somewhat." The most common problems during the first phase were difficulty to insert (61%) and discomfort (43%). However, during the second study phase a reduction in these problems (22% and 25%, respectively) and other use-related problems were noted. Although this new method is not yet available throughout Costa Rica, these results should encourage sexually transmitted diseases and HIV service organizations to make this method accessible to women.
PIP: Costa Rica has an estimated population of 3.2 million people. Contraceptive prevalence in the country was 75% in 1993, 99% of married or cohabiting women have heard about male condoms, and 96% know where to get them, but only 16% use them. Other barrier methods are either not widely used or are unavailable. Barrier contraceptive methods, however, are the only type of contraceptives which can be used to reduce the risk of contracting sexually transmitted diseases, including HIV. Even though female condoms are not yet widely available throughout Costa Rica, a study was conducted to assess short-term female condom acceptability among 51 female prostitutes in San Jose, Costa Rica. Each woman was trained how to use the female condom and asked to use it if clients refused to use male condoms during the 2-week study period. At the first of 2 scheduled follow-up visits, 51% of the women reported that they were thoroughly satisfied with the female condom, while 45% reported liking it somewhat. Similar results were reported after the second follow-up visit. 67% of the participants preferred the female condom over the male condom and the women reported that more than half of their clients liked the female condom either very much or somewhat. The most common problems encountered during the first phase of the study were difficulty in inserting the condom (61%) and discomfort (43%). However, the levels of these problems fell to 22% and 25%, respectively, during the second phase of study, while other use-related problems were noted. Study findings highlight the need to make female condoms more widely available in Costa Rica.
Assuntos
Síndrome da Imunodeficiência Adquirida/prevenção & controle , Preservativos Femininos , Comportamento do Consumidor/estatística & dados numéricos , Doenças Profissionais/prevenção & controle , Trabalho Sexual , Infecções Sexualmente Transmissíveis/prevenção & controle , Adulto , Atitude Frente a Saúde , Preservativos , Costa Rica , Feminino , Humanos , Inquéritos e QuestionáriosRESUMO
The objective of this study was to evaluate women's acceptance of and ability to self-administrate the injectable contraceptive Cyclofem using prefilled UniJect devices. A total of 102 women were invited to participate in the study. Fourteen women (13.7%) refused to participate. Of the remaining 88 women, 32 women (31.4%) consented to participate and were trained using oranges but were still afraid of the procedure and ultimately refused to self-administer the injections. Only 56 women (55%) ultimately self-injected Cyclofem with UniJect. They performed a total of 144 injections, all of them on the ventral side of the thigh. When nurses evaluated women's ability to activate the devices, they found that more than 80% were successful in both the group of women that later self-administered the injections and the group that did not. The evaluation of the self-administered injection technique showed that more than 90% of the women correctly self-administered the contraceptive using UniJect. With respect to the opinion of the women about the self-administration of the contraceptive, more than 50% (32 of 56) of women who self-injected preferred to self-administer the injection and said that they wished to continue with the self-administration, one-third (17) reported that they were afraid, and seven women (12.5%) expressed the opinion that the injection in the thigh was more painful than the administration in the buttocks or arm. In conclusion, our study showed that women can be trained to successfully self-administer the monthly injectable contraceptive Cyclofem and generally respond positively to UniJect.
PIP: Women's capability to self-administer the monthly injectable contraceptive, Cyclofem, through use of prefilled UniJect devices was evaluated in 88 volunteers recruited from three Brazilian health clinics. After training in self-injection in which oranges were used for practice, only 56 of these women (55%) elected to continue with the study. They performed a total of 144 injections on the ventral side of the thigh. When nurses evaluated women's ability to activate the UniJect device, they found more than 80% of women trained in the method and 93% of those who actually performed self-injection used the technique correctly in an angle of 90 degrees. 32 (57.1%) of the 56 women who self-injected indicated they preferred this method and wished to continue to self-inject at home, another 17 (30.4%) reported they liked the method but were afraid to perform it on their own, and seven (12.5%) complained of pain associated with injection in the thigh compared with the buttocks or arm. Self-administration of injectable contraception, a popular method in Latin American countries, has the potential to increase contraceptive coverage as well as reduce costs associated with transportation to a source of contraception. If women are to perform self-injection at home rather than at a clinic, they will require reminders about the dates of reinjection and the importance of aseptic procedures and proper disposal of injecting equipment.
Assuntos
Anticoncepcionais Femininos/administração & dosagem , Estradiol/análogos & derivados , Acetato de Medroxiprogesterona/administração & dosagem , Autoadministração , Brasil , Anticoncepcionais Orais Combinados/administração & dosagem , Combinação de Medicamentos , Estradiol/administração & dosagem , Estudos de Avaliação como Assunto , Feminino , Humanos , Injeções , Satisfação do Paciente , Fatores de TempoRESUMO
A study of the acceptability of Uniplant, a 12-month single implant of nomegestrol acetate, included 819 women from Africa, Latin America, and China, participating in a clinical trial of Uniplant. A standard, pre-coded questionnaire was specially designed for this purpose and applied at the moment of removal of implant, either at the end of 12 months of use or at the time of discontinuation for whatever reason. The level of satisfaction proved high when users' comparison with their previous contraceptive method, users' recommendation of Uniplant to others, users' intention to use the method in the future, and service satisfaction were taken into consideration. Uniplant was considered easy to use, safe (low risk of pregnancy), and also to cause fewer side effects than other methods. When asked about the least liked feature of Uniplant, almost half the respondents said that there was nothing that they disliked and about one-third mentioned the changes in their menstrual pattern. However, according to the clinical trial, over half of the Uniplant users have bleeding patterns similar to untreated cycles. The majority of respondents did not feel any discomfort during the procedure of insertion and removal of the implant. About 70% of patients in the study stated that they required contraception for more than one year and most of these women said that they did not mind having to change the implant every year.
Assuntos
Megestrol/análogos & derivados , Satisfação do Paciente , Congêneres da Progesterona , Adulto , Implantes de Medicamento , Feminino , Humanos , Entrevistas como Assunto , Megestrol/administração & dosagem , Megestrol/efeitos adversos , Satisfação do Paciente/estatística & dados numéricos , Congêneres da Progesterona/administração & dosagem , Congêneres da Progesterona/efeitos adversos , Inquéritos e QuestionáriosRESUMO
The frequency of bleeding complaints during the first year of use and their influence on removal rate were analyzed in a retrospective cohort study of 491 Norplant implants acceptors. Removal rates were significantly higher in women having menstrual complaints (1.98% and 29.23% in the first and fourth trimester) than in those who did not mention them (0.79 and 5.07% in the same periods). In all periods of observation, most women who mentioned menstrual problems decided to continue using the method. Two possible explanations for this are that 1) the complaints did not persist for very long, and 2) the most frequent complaint mentioned was bleeding irregularity, which was not as strongly associated with removals as increased or decreased bleeding. The authors conclude that bleeding problems are the most important factor limiting the acceptability of Norplant implants, either being the main reason for removal (3.9 per 100 women) or influencing the rate of removal for other reasons. Adequate counseling appears to be critical for reducing the impact of bleeding problems on removal rates, and thereby increasing the acceptability of the method. The importance of research aimed at preventing or treating menstrual problems to improve the acceptability of the method is emphasized.
Assuntos
Levanogestrel/efeitos adversos , Hemorragia Uterina/induzido quimicamente , Adulto , Estudos de Coortes , Implantes de Medicamento , Feminino , Humanos , Levanogestrel/administração & dosagem , Satisfação do Paciente , Estudos RetrospectivosRESUMO
Uniplant, a single Silastic implant containing nomegestrol acetate, provides contraceptive efficacy for one year. Uniplant use for one year was studied in 1,803 healthy women of reproductive age, enrolled from 10 centers in 9 countries, after informed consent. Implants were placed subdermally either in the upper arm or in the gluteal region. Two-hundred-seventy-six subjects discontinued prior to completing one year of study. Cumulative discontinuation rate at 12 months was 15.72%. Medical reasons for discontinuation were principally menstrual-related. Fifteen pregnancies occurred during the one year study period, resulting in a 12-month net cumulative pregnancy rate of 0.94%. Approximately 56% of subjects using Uniplant had bleeding patterns similar to normal menstruation. Results from this study confirm that Uniplant is an efficient, well tolerated, 12-month contraceptive implant, with the advantage of easier insertion and removal of the single implant compared to other multiple implant methods.
Assuntos
Anticoncepcionais Femininos/administração & dosagem , Megestrol , Norpregnadienos/administração & dosagem , Adulto , Anticoncepcionais Femininos/efeitos adversos , Implantes de Medicamento , Feminino , Humanos , Norpregnadienos/efeitos adversos , Gravidez , Congêneres da Progesterona/administração & dosagem , Congêneres da Progesterona/efeitos adversos , Hemorragia Uterina/induzido quimicamenteRESUMO
A multicenter, international, randomized, comparative trial was conducted to assess the acceptability, efficacy and safety of two different schedules of a contraceptive pill, containing 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol, administered by the vaginal route. One schedule of daily administration for 21 days with a seven-day interruption to allow withdrawal bleeding was compared to daily administration without interruption for bleeding. A total of 900 women were recruited in three countries, Brazil, Egypt and China; 7,090 women-months of vaginal pill use were recorded (3,364 using the pills intermittently and 3,726 continuously). Four undesired pregnancies occurred, one in Egypt and three in China, all four in women using the pills intermittently. There was a statistically significant difference (p = 0.486) in pregnancy rate between the two groups. There were no other significant differences in discontinuation rates despite marked differences in bleeding patterns, amenorrhea predominating in the continuous use group. Hemoglobin levels increased significantly in the two groups but hematocrit was significantly higher in the continuous use group.
PIP: 900 healthy women 16-42 years old were recruited in Brazil, China, and Egypt for a multicenter, randomized, comparative clinical trial to determine the acceptability, efficacy, and safety of two different schedules of a contraceptive pill with 250 mcg levonorgestrel and 50 mcg ethinyl estradiol administered vaginally. The two schedules were: 1) daily vaginal use of the pill for 21 days, followed by withdrawal for regular bleeding, and restarted 7 days later, and 2) use of the pill by the vaginal route nonstop for one year. There were no significant difference in cumulative discontinuation rates between the two groups (total, 15.5 for intermittent group and 14.64 for continuous group), except for unwanted pregnancy. The only unwanted pregnancies occurred to 4 women in the intermittent group (1.04%) (p = 0.0486). Women in the continuous use group were more likely than those in the intermittent group to have spotting at least once (20.6% vs. 4.4%; p 0.001). Women in the continuous group were more likely than those in the intermittent group to have amenorrhea. For example, the mean number of bleeding/spotting days during all time intervals was lower for the continuous group than for the intermittent group (p 0.001; last interval, 0.97 vs. 12.83). Hemoglobin levels increased considerably in both groups between baseline and one year of use (11.61 vs. 11.9 g/dl for intermittent group and 11.54 vs. 11.81 g/dl for continuous use; p 0.001). The mean value of hematocrit at 12 months for the continuous group was higher than that at baseline (38.8% vs. 38.2%; p = 0.011). It did not increase in the intermittent group, however. Women in both groups gained weight during the 12 months of pill use. The weight gain was significant for the continuous group only. These findings suggest that continuous use of vaginal contraceptive pills may be more advantageous than intermittent use oral contraceptives and may benefit anemic women and those who bleed heavily during menstruation.
Assuntos
Anticoncepcionais Femininos/administração & dosagem , Congêneres do Estradiol/administração & dosagem , Etinilestradiol/administração & dosagem , Levanogestrel/administração & dosagem , Administração Intravaginal , Adolescente , Adulto , Brasil , China , Anticoncepcionais Femininos/efeitos adversos , Anticoncepcionais Femininos/normas , Formas de Dosagem , Relação Dose-Resposta a Droga , Combinação de Medicamentos , Egito , Contagem de Eritrócitos , Congêneres do Estradiol/efeitos adversos , Congêneres do Estradiol/normas , Etinilestradiol/efeitos adversos , Etinilestradiol/normas , Feminino , Hematócrito , Hemoglobinas/análise , Humanos , Cooperação Internacional , Levanogestrel/efeitos adversos , Levanogestrel/normas , Fatores de TempoRESUMO
PIP: Results are presented of a clinical study of Norplant subdermal implants in Colombian adolescents. Implants have been used by 365 adolescents, of whom 174 have completed 2 years of follow-up. Study participants were monitored at months 1, 3, 6, 12, 18, and 24 postinsertion. Among the 174 women, 14% were 14-17 years old and 87% were 17-19. 21% were single, 30% married, and 49% in consensual unions. 38.5% were nulliparous, 56% had 1 child, and 5.7% had 2. 14.3% had a history of abortion. There were no pregnancies in the 2 years. 47.9% of users experienced menstrual irregularities at least once during the 2 years, with 9.3% reporting spotting or staining, 21.2% bleeding, and 19.3% amenorrhea. 6.4% reported nausea, 4.3% headache, 4.3% weight alterations, 2% acne, and 1.4% hair loss. There were 12 removals in the 2 years, 3 each because of menstrual and weight alterations, 2 for headaches, and 4 because of desire for pregnancy. 91.4% declared themselves satisfied with the method. The continuation rate was 93.2% at 2 years. The results suggest that Norplant is a good contraceptive choice for adolescents, but a prolonged study over 5 years is needed to confirm the findings.^ieng
Assuntos
Adolescente , Aceitação pelo Paciente de Cuidados de Saúde , Pesquisa , Fatores Etários , América , Colômbia , Anticoncepção , Comportamento Contraceptivo , Demografia , Países em Desenvolvimento , Serviços de Planejamento Familiar , América Latina , População , Características da População , América do SulRESUMO
PIP: The women's health movement is developing an increasing number of negative campaigns against various contraceptive methods based on three assumptions: 1) user-controlled methods are better for women than provider-controlled methods, 2) long-acting methods are undesirable because of their susceptibility to abuse, and 3) systemic methods carry unacceptable health risks to women. While these objections have sparked helpful debate, criticizing an overreliance on such methods is one thing and calling for bans on the provision of injectables and implants and on the development of vaccine contraceptives is another. Examination of the terms "provider-controlled," "user-controlled," and "long-acting" reveals that their definitions are not as clear-cut as opponents would have us believe. Some women's health advocates find the methods that are long-acting and provider-controlled to be the most problematic. They also criticize the near 100% contraceptive effectiveness of the long-acting methods despite the fact that the goal of contraception is to prevent pregnancy. It is wrong to condemn these methods because of their link to population control policies of the 1960s, and it is important to understand that long-acting, effective methods are often beneficial to women who require contraception for 20-22 years of their lives. Arguments against systemic methods (including RU-486 for early abortion and contraceptive vaccines) rebound around issues of safety. Feminists have gone so far as to create an intolerable situation by publishing books that criticize these methods based on erroneous conclusions and faulty scientific analysis. While women's health advocates have always rightly called for bans on abuse of various methods, they have not extended this ban to the methods themselves. In settings where other methods are not available, bans can lead to harm or maternal deaths. Another perspective can be used to consider methods in terms of their relationship with the user (repeated application). While feminists have called for more barrier and natural methods, most people in the world today refuse to use condoms even though they are the best protection from infection. Instead science should pursue promising new methods as well as continue to improve existing methods and to fill important gaps. Feminists should be advocates for women and their diverse needs rather than advocates against specific contraceptive methods.^ieng
Assuntos
Anticoncepção , Estudos de Avaliação como Assunto , Feminismo , Injeções , Aceitação pelo Paciente de Cuidados de Saúde , Pesquisa , Segurança , Tempo , Comportamento Contraceptivo , Demografia , Economia , Serviços de Planejamento Familiar , Saúde , População , Dinâmica Populacional , Saúde Pública , Tecnologia , Fatores de TempoRESUMO
Compared with other contraceptive methods such as sterilization and oral contraceptives, the prevalence of IUD use in Latin American countries is relatively low. This study evaluated the clinical performance of the TCu 380A IUD in six Latin American clinics to determine whether its performance was a determining factor in its low prevalence, and to provide efficacy and safety data based on local data sets to Latin American service providers. The 12-month unintended pregnancy rate ranged from 0.0 to 1.7 per 100 women and the 12-month discontinuation rates for all reasons, from 3.3 to 21.0 per 100 women. Statistically significant differences in discontinuation rates were observed among clinics, and could be explained, in part, by the different sociodemographic and clinical characteristics of women attending the clinics. The overall performance and acceptability of the TCu 380A IUD was considered satisfactory and comparable to those reported from other countries. Thus, the low prevalence of IUD use in Latin America is probably related to barriers to its use rather than its clinical performance.
PIP: Although the IUD is one of the most widely used contraceptive methods in the world, only 4.1% of reproductive aged married women in Latin America currently use it. Chile, Colombia, and Ecuador are among the few countries in the region where more than 10% of such women report its use. The authors report their findings from a clinical evaluation of the performance of the TCu 380A IUD at six clinic sites in Chile, Mexico, El Salvador, Peru, and Venezuela. Data were analyzed for two sites in Mexico. The study investigated whether the performance of the IUD was a determining factor in its low prevalence and provided efficacy and safety data based upon local data sets to Latin American service providers. The twelve-month unintended pregnancy rate among the 854 subjects ranged from 0.0-1.7 per 100 women, while the twelve-month discontinuation rates for all reasons ranged 3.3-21.0 per 100 women. The statistically significant differences in discontinuation rates observed among clinics may be partly explained by the different sociodemographic and clinical characteristics of women attending the clinics. Overall, the performance and acceptability of the TCu 380A IUD were found to be satisfactory and comparable to those reported from other countries. The low prevalence of IUD use in Latin America is therefore probably related to barriers to its use instead of to its clinical performance.
Assuntos
Dispositivos Intrauterinos de Cobre , Adulto , Feminino , Humanos , Dispositivos Intrauterinos de Cobre/efeitos adversos , América Latina , Distúrbios Menstruais/etiologia , Dor , GravidezRESUMO
PIP: Researchers are exploring ways of increasing the effectiveness and acceptability of the diaphragm. According to one Brazilian study, women tend to continue use of the diaphragm, with a higher rate of effectiveness, when it is used alone without spermicides. This may be due to convenience and cost. The retrospective study comparing 441 women who used diaphragms in conjunction with spermicides to 215 who used diaphragms alone demonstrated a significantly higher failure rate in the former group (9.8 per 100) than in the latter (2.8 per 100). There were also significantly more discontinuations for vaginal discharge and other medical reasons in the first group. The Coletivo Feminista Sexualidade e Saude in Sao Paulo, Brazil reports a high diaphragm acceptance rate with a high 1-year continuation rate (72%) among its clients. The clinic emphasizes adequate training of its clients in the use of the diaphragm, including follow up visits, which is important to the success of the method. Studies show that diaphragms used with spermicides also provide significant protection against sexually transmitted diseases. Women using this method are less likely (p .05) to have cervical gonorrhea (relative risk = .32) or trichomoniasis (relative risk = .24), or to be hospitalized for pelvic inflammatory disease.^ieng
Assuntos
Anticoncepção , Dispositivos Anticoncepcionais Femininos , Educação , Gonorreia , Doenças Parasitárias , Aceitação pelo Paciente de Cuidados de Saúde , Doença Inflamatória Pélvica , Estudos Retrospectivos , Infecções Sexualmente Transmissíveis , Espermicidas , América , Brasil , Comportamento Contraceptivo , Anticoncepcionais , Países em Desenvolvimento , Doença , Serviços de Planejamento Familiar , Infecções , América Latina , América do SulRESUMO
PIP: The 832 women who accepted Norplant implants at three hospitals in Peru between December 1988 and February 1991 participated in a study of Norplant method acceptability and user characteristics. The women were seen 1, 3, and 6 months after insertion and every 6 months thereafter. They ranged in age from 18 to 40 years and averaged 28. Nearly 78% had completed secondary school or had higher education. The average number of children was 2.1, and 87% had 3 or fewer children. 30.1% of the women had had 1 abortion, 13.0% had had 2, 2.2% had had 3, and 1.1% had had 4 or more. 47.3% of the women had previously used oral contraceptives or IUDs, 13.1% had used rhythm, 11.2% had used condoms or vaginal methods, 4.9% had used injectables, 1.6% had used other methods, and 21.9% had used no method. 47.9% stated they wanted no future pregnancies, 37.4% wanted to wait at least 3 years, and 6.3% were uncertain. Menstrual problems were the major side effect reported. 22 of the 71 removals were motivated by headaches, 18 by menstrual problems and 13 by medical problems. The continuation rate at 12 months was 88.75%. No pregnancies occurred.^ieng
Assuntos
Aceitação pelo Paciente de Cuidados de Saúde , Estudos Prospectivos , América , Anticoncepção , Comportamento Contraceptivo , Países em Desenvolvimento , Serviços de Planejamento Familiar , Planejamento em Saúde , América Latina , Peru , Pesquisa , América do SulRESUMO
Subdermal implantable contraception has been the most important addition to contraceptive technology in the past 2 decades. The Norplant system is only the first of a new family of long acting methods of high effectiveness, high acceptability, and prompt reversibility. The main advantage of the second generation implant systems, to be available soon, is the reduction in the number of implants, which greatly facilitates insertion and removal. However, great improvement in bleeding control is not to be expected. Large and carefully designed epidemiological studies have contributed to clear the main objections to the US Food and Drug Administration (FDA) approval of depot medroxyprogesterone acetate (DMPA) as an injectable contraceptive. New progestin-only, long acting injectables are being tested, but significant improvements over existing methods are difficult to foresee, although every alternative is welcome. Monthly combined injectables have been in great demand, at least in China and Latin America, because of better bleeding control. Improved combined monthly injectables, less estrogenic and more progestin dominated, have been developed and are being introduced in several countries and should soon replace the old monthly injectables. Contraceptive implants and injectables have shown to be an important addition to the contraceptive options available to women throughout both the developing and developed world.
Assuntos
Anticoncepcionais Femininos/administração & dosagem , Ensaios Clínicos como Assunto , Preparações de Ação Retardada , Implantes de Medicamento , Feminino , Humanos , Injeções Intramusculares , Levanogestrel/administração & dosagem , Acetato de Medroxiprogesterona/administração & dosagem , Microesferas , Aceitação pelo Paciente de Cuidados de Saúde , Vigilância de Produtos ComercializadosRESUMO
The objective of this multicenter randomized clinical trial was to compare the efficacy, acceptability, and occurrence of side effects associated with the oral versus vaginal route of administration of contraceptive pills. Eight hundred nineteen healthy, parous women of reproductive age were recruited at family planning clinics and research centers, members of the South to South Cooperation in Reproductive Health, in seven countries of the developing world. These women were randomly assigned to use either oral or vaginal administration of the same contraceptive pill, which contained 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol. No statistically significant differences were found in discontinuation rates between the two groups after 1 year. Involuntary pregnancy rates after 1 year were not statistically significantly different between the two groups. The vaginal route of administration appears to be as acceptable and efficacious as the oral route.
PIP: The objective of this multicenter randomized clinical trail was to compare the efficacy, acceptability, and occurrence of side effects associated with the oral versus vaginal route of administration of contraceptive pills. This study started in June, 1987, and data collection extended up to April, 1992, at family planning clinics and research centers, members of the South to South Cooperation in Reproductive Health, in seven countries of the developing world. The 819 subjects were from 17 to 39 years of age, had already had at least one pregnancy, had had regular menstrual cycles for 3 months before, were exposed to the risk of pregnancy, and were not using any other method of contraception. 424 were randomly assigned to use the pills orally (which contained 250 mcg levonorgestrel and 50 mcg ethinyl estradiol), whereas 395 inserted the pills vaginally. 625 subjects completed at least 6 months of use, 326 used the pills orally and 299 used the pills vaginally. 385 subjects completed 1 year of pills use, 201 in the oral group and 184 in the vaginal group. The 1-year discontinuation rate per 100 subjects per year for the oral group was 34.71 +or- 2.42, while it was 36.35 +or- 2.53 for the vaginal group. This difference was not statistically significant. The only single reason of statistically significant difference for discontinuation was "desire for pregnancy" (p = 0.444). Paired value analysis of subjects completing 12 months of study showed that women in the oral group had a statistically significant increase in weight, from a mean of 55.8 kg at admission to a mean of 56.9 kg at 6 months (p 0.05) and 57.3 kg at 1 year (p = 0.05). The mean weight of the vaginal group increased from 56.52 kg to 57.22 kg (p = 0.036) at 12 months. Significantly more complaints of vaginal discharge were recorded in women using the pills by the vaginal route (p = 0.001). However, only one subject discontinued the pills because of vaginal discharge.
Assuntos
Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Orais Hormonais , Administração Intravaginal , Adolescente , Adulto , Anticoncepcionais Femininos/efeitos adversos , Anticoncepcionais Orais Hormonais/efeitos adversos , Países em Desenvolvimento , Feminino , Humanos , Cooperação do PacienteRESUMO
The experience of 670 diaphragm users from three Brazilian clinics was retrospectively reviewed. Most of the subjects (441) followed the traditional method (TM) of using the diaphragm, only at the time of sexual intercourse and with spermicide. One third (215) used the diaphragm continuously (CU), without spermicide, removing it only at the time of their daily shower to wash it, with immediate re-insertion. The total pregnancy rate was 7.0 per 100 women-years for the whole group. Patient and total failure rate were significantly lower in the CU (0.6 and 2.8), in comparison with the TM sub-group (6.5 and 9.8). The discontinuation rate for urinary infection or other medical reasons was not greater in the CU group. Logistic regression analysis, including age, parity, number of abortions and of living children, years of schooling, whether living with a partner, presence of mild cystocele or retroverted uterus, and form of use of diaphragm (TM or CU), showed that only the TM of diaphragm use was positively associated to patients' and total failure rate.
PIP: In Brazil, a retrospective review of clinical records of diaphragm users from the Sexuality and Health Women's Collective in central Sao Paulo, the family planning clinic at the State University of Campinas, and a private practice in Belo Horizonte was performed to compare data on 215 women continuously using it without spermicide, except to clean it during a shower, with data on 441 women using it with spermicide only during sexual intercourse to determine diaphragm effectiveness. The patients' failure rate stood considerably higher among women using the diaphragm with spermicide (6.5 vs. 0.61; p .05). The method failure rate was just slightly higher in the diaphragm with spermicide users' group (3.53 vs. 2.2). 71.47% of all women continued use for 12 months, especially women continuously using the diaphragm without spermicide (84.84 vs. 63.28%; p .05). Women who used the diaphragm with spermicide were more likely to discontinue for vaginal discharge and for other medical and personal reasons than were those who continuously used it without spermicide (p .05). They were also more likely to be lost to follow up (16.4% vs. 6.43%; p .05). The logistic regression analysis indicated that diaphragm with spermicide use was positively linked to patients' and total failure (p = .042). These findings suggested that the messiness of diaphragm use with spermicide, its interference with sexual intercourse, and perhaps spermicide cost contributed to its high discontinuation and failure rates. The findings should raise interest in identifying means to improve acceptance of and use effectiveness of the diaphragm.
Assuntos
Dispositivos Anticoncepcionais Femininos , Adulto , Feminino , Humanos , Análise de Regressão , Estudos Retrospectivos , EspermicidasRESUMO
A comparative multicenter clinical trial of two combined oral contraceptives (OCs) was conducted at clinics located in the Sudan, Sri Lanka, Chile, the Dominican Republic and Ecuador. The trial was designed to determine if there were differences in efficacy, safety and acceptability between a triphasic and a low-dose monophasic OC. This report includes analysis of 1088 women. At each center, subjects were randomly allocated to one of the two OCs. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. There were two accidental pregnancies attributed to user failure reported during the study period; one in the triphasic group and one in the monophasic group. Adverse experiences were mainly minor with headaches and dizziness being the most common complaints; frequency of reports was similar in both groups. Cycle control was good in both groups with women in the triphasic group reporting fewer complaints of intermenstrual bleeding. Both OCs were safe and effective.
PIP: Researchers compared the efficacy, safety, and acceptability of a triphasic oral contraceptive (OC), Triquilar, with those of a monophasic OC, Lo-Femenal, among 1088 women attending clinics in Chile, the Dominican Republic, Ecuador, Sri Lanka, and the Sudan. Both OCs contained levonorgestrel and ethinyl estradiol. 90% of women in each group exhibited good user compliance. Only 1 unplanned pregnancy occurred in each group, and both pregnancies were attributed to user failure. The gross cumulative efficacy rates at 11 months were 0.3/100 woman-years for the triphasic OC and 0.2/100 woman-years for the monophasic OC. The continuation rate at 11 months was lower for Lo-Femenal than it was for Triquilar (80.8% vs. 84.6%), but the difference was not significant. The leading side-effect-related reason for discontinuation in both groups was headache. Another key reason for OC discontinuation in both groups was personal reasons, such as planning a pregnancy. Most women in both groups did not have menstrual complaints (78.8% for the Triquilar group and 77.1% for the Lo-Femenal group). Intermenstrual bleeding rates were low (7.6% for the Triquilar group and 9% for the Lo-Femenal group). Significant intercenter differences for women reporting intermenstrual bleeding and side effects (e.g., headaches) existed (p .05). Women from both groups at the clinic in the Sudan always had lower reports of intermenstrual bleeding than those at the other clinics. In fact, no woman discontinued OC use because of intermenstrual bleeding in the Sudan. Women in Sri Lanka reported fewer side effects than those in other countries, suggesting they could better tolerate OCs than the other women. This multicenter study's findings indicates that both Triquilar and Lo-Femenal are effective and safe. In addition, they exhibit good cycle control.
Assuntos
Anticoncepcionais Orais Combinados , Adolescente , Adulto , Chile , Anticoncepcionais Orais Combinados/administração & dosagem , Anticoncepcionais Orais Combinados/efeitos adversos , República Dominicana , Equador , Etinilestradiol/administração & dosagem , Etinilestradiol/efeitos adversos , Combinação Etinil Estradiol e Norgestrel , Feminino , Humanos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Norgestrel/administração & dosagem , Norgestrel/efeitos adversos , Gravidez , Sri Lanka , SudãoRESUMO
NORPLANT is the newest contraceptive system to be introduced world-wide, with nearly a million current users. It consists of six Silastic capsules containing levonorgestrel (LNg), which are inserted under the skin in the arm. Release of the steroid commences immediately so that, after several weeks, circulating levels of LNg stabilize between 0.3 and 0.4 ng/ml of plasma, and they persist elevated with a minor decline for over 5 years. The gross cumulative pregnancy rate at 5 years is 2.6 per 100 woman-years. In the majority of women it produces no abnormalities in a variety of clinical chemistry, metabolic, haematological and coagulation parameters. The most common side-effect is disruption of the menstrual bleeding pattern; this is reported by two-thirds of the users in the first months and by one-third by the fifth year. Because it is the most disturbing side-effect for many users, counselling prior to insertion is of paramount importance. NORPLANT exerts varying degrees of gonadotrophin and ovarian inhibition, including anovulation and luteal insufficiency. Endometrial development is irregular and, irrespective of oestrogen levels, cervical mucus is thick and scanty at all times due to the strong antioestrogenic effect of LNg. Inhibition of sperm penetration fully accounts for the antifertility effect of NORPLANT in ovulatory cycles. The high contraceptive efficacy, lack of serious side-effects, reversibility and the convenience of long-term unattended use explain the high acceptability of NORPLANT.
Assuntos
Levanogestrel , Peso Corporal , Implantes de Medicamento , Feminino , Antebraço , Humanos , Levanogestrel/efeitos adversos , Ciclo Menstrual/fisiologia , Distúrbios Menstruais/etiologia , GravidezRESUMO
PIP: The choice of the most appropriate contraceptive method, when its use is begun, and the motivation of adolescents to use it, are significant factors in adolescent contraceptive continuation. The contraceptive method must suit the personality of the adolescents, who are insecure in most cases, less stable emotionally, rebellious, and uninformed. This pattern can induce constant changes of partners, and accidental and unpredictable sexual activity. Since adolescence is a period of biological and psychological transformation, the contraceptive must be highly effective, safe, and well-tolerated, so that its side effects should not prejudice the continuation of its use. The behavioral contraceptive methods, coitus interruptus, ovulation, and sympto-thermal methods, are contraindicated for adolescents because of their low effectiveness and the requirement of a great deal of discipline. The condom, diaphragm, and spermicides can prevent sexually transmitted diseases, thus they are optimal for adolescents. Their effectiveness is higher than that of behavioral methods but could be better, and they require a certain discipline, which limits sexual spontaneity. The IUD is contraindicated in adolescents and in women who have never given birth, because of the possibilities of pelvic inflammation resulting in pain and bleeding and expulsion of the IUD. The use of hormonal contraception is recommended only two years after the first menstruation, for fear of interference in the biological development of the adolescent. Recent studies have shown that modern low-dose oral contraceptives (OCs) do not exert harmful effects on the adolescent organism. While paying heed to contraindications, OCs can be indicated for this age group. Hormonal contraceptives are effective, safe, and well-tolerated by the majority of patients. They regulate menstruation, and provide beneficial effects such as the reduction of dysmenorrhea and the protection against pelvic inflammatory diseases, benign diseases of the breast, and even uterine and ovarian cancer.^ieng
Assuntos
Adolescente , Anticoncepção , Anticoncepcionais Orais , Serviços de Planejamento Familiar , Dispositivos Intrauterinos , Aceitação pelo Paciente de Cuidados de Saúde , Fatores Etários , América , Brasil , Comportamento Contraceptivo , Demografia , Países em Desenvolvimento , América Latina , População , Características da População , América do SulRESUMO
One single silastic capsule containing nomegestrol acetate, Uniplant, was inserted subcutaneously in 100 women of reproductive age who desired to avoid conception. Insertions and removals of the capsules were made in the gluteal region following intracutaneous local anesthesia with 2% procaine. Eighty women completed one year of use. Eleven women bore the implant for 6-11 months. A total of 1,085 women-months were recorded. One pregnancy occurred, resulting in a Pearl Index of 1.1. Bleeding episodes similar to menstruation occurred in all women but the degree of regularity varied from subject to subject. Amenorrhea developed in the range of 14-18% during the first six months of use but declined to less than 10% during the last six months. Menorrhagia likewise was higher in the first six months (18% in the first month) but fell to less than 10% during the last six months. Spotting was 5% or less. Of the twenty women who did not complete one year of use, nine discontinued because they found other methods were either more practical or less revealing. Three discontinued because of bleeding irregularities, three desired to become pregnant, one became pregnant. Other complaints included dizziness, headache, increased blood pressure, loss of libido, painful breasts and nausea. Over half of the women indicated their desire to continue using the single implant as a contraceptive.
Assuntos
Implantes de Medicamento , Megestrol , Norpregnadienos/farmacologia , Congêneres da Progesterona/farmacologia , Adulto , Pressão Sanguínea/efeitos dos fármacos , Peso Corporal/efeitos dos fármacos , Feminino , Humanos , Menstruação/efeitos dos fármacosRESUMO
The efficacy and acceptability of two widely used oral contraceptive tablets, one containing 250 mg levonorgestrel and 50 micrograms ethinyl estradiol and the other containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol, administered by the vaginal route were compared in 1055 women studied over 12,630 woman-months of vaginal contraceptive pill use. This multicenter clinical trial was performed in nine countries of the developing world by the "South to South Cooperation in Reproductive Health," an organization founded by scientists from the Third World working in the area of reproductive health, and the study was developed and coordinated by one of these centers. The findings of this study confirm the efficacy of both these tablets when administered by the vaginal route. Involuntary pregnancy rates at 1 year of 2.78 for subjects in the levonorgestrel group and 4.54 for subjects the desogestrel group showed no statistically significant difference between the two groups. However, total discontinuation rates of 47.01 for subjects in the levonorgestrel group and 56.33 for subjects in the desogestrel group showed a statistically significant difference between the two groups, and discontinuation rates attributable to prolonged bleeding of 0.6 for subjects in the levonorgestrel group and 3.2 for subjects in the desogestrel group were also significantly higher in the group of subjects using the desogestrel vaginal contraceptive pill. Blood pressure remained at admission values throughout treatment. A statistically significant weight increase from admission values occurred in both groups of subjects.
PIP: Efficacy and acceptability of 2 combined oral contraceptive pills administered vaginally are summarized. This is the 1st collaborative trial published by the South to South Cooperation in Reproductive Health. 1055 women participated in 12,630 cycles, in 9 countries, from June 1988 to May 1991. The pills were commercially available tablets containing 50 mcg ethinyl estradiol and 250 mg levonorgestrel (Schering AG, Sao Paulo, Brazil), or 30 mcg ethinyl estradiol and 15 mcg desogestrel (Organon, Sao Paulo, Brazil). Subjects were aged 17-39 younger and of lower parity from Mexico and Dominican Republic and older from Egypt and China. All had at least 1 pregnancy. 675 participated for 6 months, 470 for 1 year, 364 for 18 months, and 210 for 2 years. The 1-year discontinuation rate averaged 47.01% for the levonorgestrel group and 56.33% for the desogestrel group (p = 0.0061); 2-year discontinuation rates were 48.01% and 69.36, respectively, explained in part by higher involuntary pregnancy rates and prolonged bleeding rates in the desogestrel group. The most common medical reasons for stopping contraception were unplanned pregnancy, vaginal or vulval irritation, nausea, vaginal discharge and headache. Vaginal irritation was reported by 1%, 9 in each group. There were 32 pregnancies, 14 in the levonorgestrel and 18 in the desogestrel group. 17 were in missed pill cycles and the rest were method failures, 6 in the levonorgestrel group and 9 in the desogestrel group. The Pearl index varied from 0 in Nigeria to 12.24 in Mexico, and was 2.45 for levonorgestrel vs. 3.74 for desogestrel. There was a wide variation in discontinuation rates by center: Brazil and China had few, while many women from Dominican Republic, Mexico and Zambia left the study. Bleeding problems were common complaints, more so in the desogestrel group. There were 363 women with intermenstrual bleeding (only once in 80%), 148 with spotting (only twice in 65%). Bleeding duration was significantly less in pill cycles than baseline, pressure. Women gained an average of 1 kg over 2 years, more in the desogestrel group. The pregnancy rate of 2.78 is within the range reported for levonorgestrel rings.