RESUMEN
Despite the low contraceptive prevalence among the Mayan population of Guatemala, past research has found interest in natural methods. A calendar rhythm method with a simple blanket rule would appear to be preferable to more complicated methods. Under a blanket rule, the number of days of abstinence is predetermined and all couples are instructed to abstain during the same interval of the menstrual cycle. However, regular menstrual cycles may be key to successful practice of a calendar method. A database of 880 cycles of 301 women of the Guatemalan highlands was analyzed to determine the length and regularity of menstrual cycles in this population.
PIP: This article reports on the irregular cycle incidence among Mayan women who reported regular cycles. Data from a research study of a blanket 9-19 calendar rhythm method were analyzed to assess the regularity of cycles among the subjects. The necklace method tested in this study is a natural family planning method utilizing the "blanket rule". Sexual abstinence starts on day 9 of the menstrual cycle until day 19. A necklace with 30 beads is used as a mnemonic device. Findings showed that the menstrual cycles of highland Guatemalan women may not be very regular, indicating that women interested in practicing a method with a standard rule of abstinence could be taking risks of getting pregnant. Pregnancies occurred during the course of the study, suggesting cycles of irregularity. Given these results, programs that teach fertility awareness methods should help Mayan women monitor the length of their cycles more closely.
Asunto(s)
Ciclo Menstrual , Métodos Naturales de Planificación Familiar , Detección de la Ovulación , Adolescente , Adulto , Femenino , Guatemala , Humanos , Ovulación , Probabilidad , Factores de TiempoRESUMEN
Healthy, regularly menstruating women, aged 14-38 years, were enrolled in a comparative, double-blind, phase III, clinical trial to evaluate the contraceptive efficacy and acceptability of a combination of 90 mg dihydroxyprogesterone acetophenide with 6 mg estradiol enanthate compared to the commercially available contraceptive combination of 150 mg dihydroxyprogesterone acetophenide with 10 mg estradiol enanthate. Subjects received the contraceptive combination intramuscularly, between the 7th and 10th day of each menstrual cycle, during 12 consecutive menstrual cycles. Approximately 60% of the subjects in both groups completed the study. Principal reasons for discontinuation were personal, nonmedical reasons. Principal medical reasons for discontinuation were menstrual-related, irregular bleeding being the most frequent. Differences in menstrual patterns between the two groups did not lead to differences in discontinuation rates. Three contraceptive failures occurred during the trial, one in Group A (90/6 mg) and two in Group B (150/10 mg), indicating that the lower dose formulation is at least as efficient as the higher dose.
Asunto(s)
Acetofenida de Algestona/efectos adversos , Anticonceptivos/efectos adversos , Estradiol/análogos & derivados , Menstruación/efectos de los fármacos , Congéneres de la Progesterona/efectos adversos , Hemorragia Uterina/inducido químicamente , Adolescente , Adulto , Acetofenida de Algestona/administración & dosificación , Peso Corporal , Brasil , Estudios de Cohortes , Anticonceptivos/administración & dosificación , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Estradiol/administración & dosificación , Estradiol/efectos adversos , Femenino , Humanos , Incidencia , Menstruación/fisiología , Aceptación de la Atención de Salud , Pacientes Desistentes del Tratamiento/estadística & datos numéricos , Congéneres de la Progesterona/administración & dosificación , Hemorragia Uterina/epidemiologíaRESUMEN
The efficacy of a low dose of mifepristone, 5 mg/day for the first 15 days of the menstrual cycle, followed by medroxy-progesterone acetate (MPA), 10 mg/day for the next 13 days, for inhibiting ovulation was assessed in ten volunteers who were treated for three successive cycles. Hormonal determinations in blood and urine samples, ovarian ultrasonography and an endometrial biopsy taken on day 21-24 of the third treatment cycle were used to monitor the cycles. Ovulation was confirmed in 11 of the 30 treated cycles and, in these 11, the LH peak and follicular rupture occurred during MPA treatment periods. Out of 19 anovulatory cycles, 16 had no increase in progesterone levels and another 3 developed a luteinized unruptured follicle. Progestin administration induced secretory changes in the endometrium, but irregular or delayed development was found. Regular withdrawal bleeding occurred in all subjects. These data indicate that the sequential regimen can suppress ovulation while maintaining regular bleeding but increased efficacy is needed for phase II clinical trials.
PIP: The efficacy of a low dose of mifepristone, 5 mg/day for the first 15 days of the menstrual cycle, followed by medroxyprogesterone acetate (MPA), 10 mg/day for the next 13 days, for inhibiting ovulation was assessed in 10 Chilean volunteers who were treated for 3 successive cycles. They were healthy, surgically sterilized women with a mean age of 36.6 years and mean weight of 58.6 kg. Hormonal determinations in blood and urine samples, ovarian ultrasonography and an endometrial biopsy taken on days 21-24 of the third treatment cycle were used to monitor the cycles. Treatment inhibited ovulation during the 3 treatment cycles in 5 women. The regimen was partially effective in 3 women and totally ineffective in another 2 women. Ovulation was confirmed in 11 of the 30 treated cycles, and, in these 11, the luteinizing (LH) peak and follicular rupture occurred during MPA treatment periods. Out of 19 anovulatory cycles, 16 had no increase in progesterone levels and another 3 developed a luteinized unruptured follicle. Among the anovulatory cycles, 3 cycles presented a biphasic hormonal profile. In these 3 cycles the luteal phase progesterone level were much lower than in baseline cycles and they were associated with unruptured follicles. The other 16 cycles had a monophasic hormonal profile with no increase in progesterone levels in spite of a delayed rise in LH level. Progestin administration induced secretory changes in the endometrium, but irregular or delayed development was found. Only 9 post-treatment cycles were followed and 5 of these were ovulatory, 1 of them without a detectable LH midcycle peak. Regular withdrawal bleeding occurred in all subjects. These data indicate that the sequential regimen can suppress ovulation while maintaining regular bleeding, but increased efficacy is needed for phase II clinical trials.
Asunto(s)
Endometrio/efectos de los fármacos , Hormonas/metabolismo , Acetato de Medroxiprogesterona/administración & dosificación , Mifepristona/administración & dosificación , Ovario/efectos de los fármacos , Adulto , Biopsia , Endometrio/fisiología , Estradiol/sangre , Femenino , Humanos , Hormona Luteinizante/sangre , Ciclo Menstrual/efectos de los fármacos , Folículo Ovárico/efectos de los fármacos , Folículo Ovárico/fisiología , Ovario/diagnóstico por imagen , Ovario/fisiología , Ovulación/efectos de los fármacos , Progesterona/sangre , Factores de Tiempo , UltrasonografíaRESUMEN
OBJECTIVE: Our purpose was to evaluate whether prolonged or irregular bleeding during Norplant implant use could be alleviated with the use of oral hormonal medication. STUDY DESIGN: One hundred fifty users of the Norplant levonorgestrel contraceptive implant with prolonged or frequent bleeding were enrolled in this prospective, randomized, comparative study and assigned to one of three treatment groups for 20 days: ethinyl estradiol 50 microg, an oral contraceptive (50 microg ethinyl estradiol and 250 microg levonogestrel), and placebo. Total days of bleeding during treatment and length of the bleeding-free interval were analyzed. RESULTS: Women treated with the levonorgestrel-ethinyl estradiol pill bled an average of 2.6 days during treatment compared with 5.4 and 12.3 days in the ethinyl estradiol and placebo groups, respectively. Differences between both hormonal groups and placebo were significant (p <0.00001); moreover, the combined pill was more effective than ethinyl estradiol along (p <0.0001). CONCLUSION: The combined pill proved to be an excellent palliative treatment and is a more practical approach because of availability at all clinic sites.
PIP: In the Dominican Republic, clinical researchers randomly assigned 150 users of the contraceptive implant Norplant who came to Profamilia's Family Planning Clinic in Santo Domingo complaining of bleeding irregularities to one of three treatment groups. They aimed to evaluate the effectiveness of a combined oral contraceptive (OC) with 250 mcg levonorgestrel and 50 mcg ethinyl estradiol (EE) and of 50 mcg EE alone in treating bleeding irregularities. Bleeding irregularities were defined as prolonged bleeding (i.e., 8 or more continuous days of bleeding or spotting) or irregular bleeding (i.e., current bleeding episode initiated after a bleeding-free interval of less than 15 days). Age, parity, duration of Norplant use, and length of bleeding episode before treatment were similar in all three groups (i.e., OC, EE, and placebo). The OC group was significantly more likely to experience ceased bleeding within three days than the two other groups (91% vs. 67% for EE group [p 0.01 from OC group] and 15% for placebo group [p 0.0005 from both treatments]). Bleeding lasting for at least one week occurred less often in the OC group than the two other groups (2% vs. 14% for EE group and 50% for placebo group [p 0.0005 for both treatments]). Duration of bleeding was significantly lower in the OC group than the other two groups (2.6 days vs. 5.4 days for EE group and 12.3 days for placebo group; p 0.0001). Even though women in both hormonal treatment groups were more likely to experience gastralgia or nausea than the placebo group (33-40% vs. 4%; p 0.005), the side effects rarely interrupted treatment. These findings suggested that the OC is a very good effective treatment for bleeding irregularities and is a practical treatment since it is available at all Profamilia clinic sites.
Asunto(s)
Anticonceptivos Femeninos/efectos adversos , Anticonceptivos Orales Combinados/uso terapéutico , Congéneres del Estradiol/uso terapéutico , Etinilestradiol/uso terapéutico , Levonorgestrel/efectos adversos , Hemorragia Uterina/tratamiento farmacológico , Adulto , Análisis de Varianza , Distribución de Chi-Cuadrado , Implantes de Medicamentos , Femenino , Humanos , Levonorgestrel/uso terapéutico , Estudios Prospectivos , Hemorragia Uterina/inducido químicamenteRESUMEN
PIP: In developing countries with high levels of malnutrition and iron deficiency, the menstrual blood loss sometimes associated with IUD use can represent a serious maternal health concern. To identify the IUD models associated with the least amount of bleeding, 365 clients of the Mexican Institute of Social Security's Volunteer Family Planning Program participated in a 12-month comparative study of 11 IUDs. Menstrual blood loss was measured before IUD insertion; at 1, 3, 6, 9, and 12 months; and 1, 2, and 3 months after removal. Mean menstrual blood loss at baseline was 43.6 +or- 6.3 ml. The greatest increase in bleeding (above 80 mg) was recorded among acceptors of the Lippes Loop-D and Copper T-380 devices; the Copper T-200 and 220C and Multiload 250 were in an intermediate position (below 80 mg), while the Copper 7 induced little change. In contrast, users of the 5 progestogen-releasing IUDs experienced a decline in menstrual bleeding that was proportional to the amount of steroids released or the progestational potency. This reduction was greatest (96%) for the IUD that released 8 mcg/day of levonorgestrel. However, this category of IUDs is more costly and necessitates earlier removal; in addition, many women discontinue use of hormone-releasing IUDs precisely because of the associated amenorrhea. Recommended, therefore, is promotion of the Copper T-220C, which can remain in place for 10 years. In selected cases, short-term treatment with nonsteroidal anti-inflammatory agents can reduce IUD-associated hypermenorrhea and promote contraception continuation.^ieng
Asunto(s)
Dispositivos Intrauterinos de Cobre , Dispositivos Intrauterinos Medicados , Bienestar Materno , Trastornos de la Menstruación , Américas , Anticoncepción , Países en Desarrollo , Enfermedad , Servicios de Planificación Familiar , Salud , Dispositivos Intrauterinos , América Latina , México , América del Norte , InvestigaciónRESUMEN
Available contraceptive implants appeal to women of diverse cultural and socioeconomic background because they offer long-term contraception, safety, effectiveness, reversibility and lack of estrogenic side-effects. Experience with Norplant I indicates that despite some side-effects the continuation rate is the highest for any reversible method of contraception. Disruption of the menstrual cycle is the main reason for discontinuation, hence research effort needs to focus on the mechanism of progestogen-induced endometrial bleeding and appropriate therapy. Implant service programs should have trained and skilled personnel who can provide adequate counseling that complements any public education effort and also provides effective services. Because contraceptive implants offer no protection against sexually transmitted infections, those who engage in high-risk sexual behavior should be encouraged to use condoms as well.
PIP: Women of diverse cultural and socioeconomic levels choose available contraceptive implants because of long-term contraception, safety, effectiveness, reversibility, and lack of estrogenic side effects. Norplant is a safe, effective method of reversible fertility regulation, as shown by studies in several countries with diverse sociocultural and demographic profiles. However, the major shortcoming is menstrual disorders, which cause about half of all discontinuations. Since the US Food and Drug Administration approved the use of Norplant in December 1990, acceptability among the diverse general population was largely dependent on the intensity of counseling. Removal rates of Norplant implants in adolescents were similar to those for mature women, and in general implant acceptability, continuation, and tolerance of side effects were high and comparable among adolescent and adult acceptors. Abnormal bleeding patterns still represent the most common complaint and reason for discontinuation among adolescents and adults. The insertion and removal of Norplant requires appropriate training of physicians and nonphysicians who plan to provide Norplant services. Norplant II consists of 2 silastic rods each containing 70 mg levonorgestrel. Phase III clinical trials in 1466 Indian women observed for 52,849 woman-months of use resulted in a method failure rate of 6.8 per 100 users and a continuation rate of 42.1 per 100 users at 5 years of use. Nomegestrol acetate implant is a second-generation single silastic implant containing 55 mg nomegestrol acetate with contraceptive effectiveness of 1-year duration. Implanon implant is a single ethylene vinyl acetate rod containing 60 mg 3-ketodesogestrel with more progestogenic and less androgenic activity than levonorgestrel and 2-year effectiveness. ST-1435 implant contains ST-1435, a synthetic progestin which inhibits ovulation when administered parenterally but not orally. If appropriate counseling is provided implants can be a popular method of contraception in different parts of the world.
Asunto(s)
Anticonceptivos/administración & dosificación , Implantes de Medicamentos , Megestrol , Adolescente , Adulto , Comportamiento del Consumidor , Seguridad de Productos para el Consumidor , Desogestrel , Implantes de Medicamentos/efectos adversos , Femenino , Humanos , Levonorgestrel , Trastornos de la Menstruación/inducido químicamente , NorpregnadienosRESUMEN
The clinical performance of the Copper T 380A (TCu 380A) and the Copper T 220C (TCu 220C) intrauterine devices (IUDs) were evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at four collaborating research sites located in two developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the TCu 220C IUD at 12 months (0.3 and 0.8, respectively), although this difference was not statistically significant (p > 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, personal reasons, medical reasons, or planned pregnancy. No statistically significant differences were observed in the frequency of experiencing menstrual disturbances (i.e., dysmenorrhea, intermenstrual pelvic pain or intermenstrual bleeding) between the two IUD groups. These data suggest that the TCu 380A and TCu 220C IUDs are both appropriate options for contracepting women. The TCu 380A IUD, however, may be a more appropriate option for those women wishing to space births over a longer period of time.
Asunto(s)
Países en Desarrollo , Servicios de Planificación Familiar , Dispositivos Intrauterinos de Cobre , Adolescente , Adulto , Femenino , Enfermedades de los Genitales Femeninos/etiología , Humanos , Infecciones/etiología , Inflamación/etiología , Dispositivos Intrauterinos de Cobre/efectos adversos , Trastornos de la Menstruación/etiología , México , Filipinas , EmbarazoRESUMEN
Sixty users of the IUD who complained of abnormal menstrual blood loss were evaluated by hysteroscopy, and the findings were compared with a matched group who had this investigation for "missing strings". Submucous fibroids and endometritis were more frequent in the study group whereas malposition of the IUD was commoner in the controls (p < 0.05).
PIP: Hysteroscopic findings in 60 Jamaican IUD users who complained of excessive bleeding revealed a high incidence of submucous fibroids and inflammatory lesions. Study subjects, recruited from the family planning clinic at the University of the West Indies, were using the Lippes Loop C or D; the average duration of use was 3.6 years. 60 matched controls undergoing hysteroscopic evaluation of missing IUD strings served as controls. Uterine abnormalities were detected in 42 of the 60 cases compared with only 26 of 60 controls (p 0.05). Submucous fibroids were identified in 16 cases and only 6 controls; endometriosis was present in 18 cases and 14 controls, while 4 cases and 2 controls had "suspicious" endometrium. Malposition of the IUD or penetration of the uterine wall was present in 14 cases compared to 36 controls. Until the levonorgestrel-releasing IUD (associated with reduced menstrual blood loss) becomes available in Jamaica, use of hysteroscopy is recommended to evaluate excessive bleeding in IUD users.
Asunto(s)
Histeroscopía , Dispositivos Intrauterinos/efectos adversos , Hemorragia Uterina/diagnóstico , Adulto , Estudios de Evaluación como Asunto , Femenino , Humanos , Hemorragia Uterina/etiologíaRESUMEN
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.
Asunto(s)
Implantes de Medicamentos , Megestrol , Norpregnadienos/farmacología , Congéneres de la Progesterona/farmacología , Adulto , Presión Sanguínea/efectos de los fármacos , Peso Corporal/efectos de los fármacos , Femenino , Humanos , Menstruación/efectos de los fármacosRESUMEN
Reported is the use of a simplified methodology for carrying out a community-based epidemiological assessment that is compatible with the goals of primary health care research. For this purpose, a current-status life table analysis of data from 1131 women who were served by community health workers in the State of México was used to determine the distributions of the duration of postpartum breast-feeding, amenorrhoea, and contraceptive use. The field methods used incorporated quality assurance procedures. At 1 month postpartum, 78% of the infants were still being breast-fed, at 5 months 50%, and at 12 months 25%. The level of amenorrhoea at 1 month postpartum was 85%, at 3 months 50%, and at 5 months 25%. Use of contraceptives was initiated at an early stage, with 42% of all users beginning during the first month postpartum. The simplified method described permitted the area's primary health care administrators to carry out research projects for programme development rapidly and was compatible with the locally available resources.
PIP: Reported here is the use of a simplified methodology for carrying out a community-based epidemiological assessment that is compatible with the goals of primary health care research. For this purpose, a current status life table analysis of data from 1131 women who were served by community healthworkers in the state of Mexico was used to determine the distributions of the duration of postpartum breastfeeding, amenorrhea, and contraceptive use. The field methods used incorporated quality assurance procedures. At 1 month postpartum, 78% of the infants were still being breastfed, at 5 months 50%, and at 12 months 25%. The level of amenorrhea at 1 month postpartum was 85%, at 3 months 50%, and at 5 months 25%. Use of contraceptives was initiated at an early stage, with 42% of all users beginning during the 1st month postpartum. The simplified method described permitted the area's primary health care administrators to carry out research projects for program development rapidly and was compatible with the locally available resources. (author's)
Asunto(s)
Amenorrea , Lactancia Materna , Adulto , Anticonceptivos Orales , Utilización de Medicamentos , Femenino , Humanos , Lactante , Tablas de Vida , México , Muestreo , Factores de TiempoRESUMEN
The safety and efficacy of a low-dose monophasic oral contraceptive (OC) containing a new progestogen, gestodene (GTD), combined with ethinyl estradiol (EE) is being investigated in two ongoing multicenter trails. In this interim analysis, the formulation was found to be effective and well tolerated. Subject compliance was excellent; no pills were missed in 91.2% of the cycles. The number of women who withdrew from the study was low (15%), indicating good subject acceptance. GTD + EE provided optimal cycle control. Of the total number of OC cycles analyzed, spotting occurred in 8.1%, breakthrough bleeding in 1.8%, and both spotting and breakthrough bleeding in 3.3%. The incidence of spotting decreased fairly steadily during OC administration. Amenorrhea occurred in 0.5% of the cycles. There were no unexpected or serious side effects. The incidence of side effects was low and declined with increased duration of OC use. There were no clinically significant changes in weight or blood pressure. Virtually all of the systolic and diastolic blood pressure readings were in the normal range. The results of this interim analysis indicate that the GTD + EE formulation is a safe and reliable contraceptive.
Asunto(s)
Etinilestradiol/farmacología , Ciclo Menstrual/efectos de los fármacos , Norpregnenos/farmacología , Adolescente , Adulto , Presión Sanguínea/efectos de los fármacos , Peso Corporal/efectos de los fármacos , Mama/efectos de los fármacos , Anticonceptivos Orales Combinados/efectos adversos , Anticonceptivos Orales Combinados/farmacología , Etinilestradiol/efectos adversos , Europa (Continente) , Femenino , Estudios de Seguimiento , Cefalea/inducido químicamente , Humanos , Conformación Molecular , Estructura Molecular , Estudios Multicéntricos como Asunto , Náusea/inducido químicamente , Norpregnenos/efectos adversos , Cooperación del Paciente , América del SurRESUMEN
A non-comparative study of the progestogen-only oral contraceptive, norgestrel 0.075 mg, in breast-feeding women was conducted at the Centro de Investigaciones Regionales, Merida, Yucatan, Mexico. The study was designed to evaluate the overall acceptability and contraceptive efficacy of norgestrel in breast-feeding women. This report includes a survey of 200 women, all of whom were less than 26 weeks postpartum at admission; 113 were interval patients and 87 were postpartum. Follow-up visits were scheduled at 2, 6 and 12 months after admission. Overall, women experienced an increase in intermenstrual bleeding, amenorrhea, vaginal discharge and breast discomfort. The discontinuation rate at 12 months was 32.5 and the corresponding lost to follow-up rate was 22.5; this is a measure of acceptability. The 12-month life-table rate for pregnancy was 3.4 with a standard error of 2.0. Three women discontinued use of the mini-pill due to accidental pregnancy. One pregnancy was attributed to user failure and the woman conceived 9 months after entering into the study; the other two were attributed to method failure, one woman conceived 3 months after admission and the other conceived 6 months after admission.
Asunto(s)
Lactancia/efectos de los fármacos , Norgestrel , Adulto , Servicios de Planificación Familiar , Femenino , Estudios de Seguimiento , Humanos , Norgestrel/efectos adversos , Norgestrel/farmacología , EmbarazoRESUMEN
A comparative clinical trial of two combined oral contraceptives (OCs) with equivalent estrogen content, but different amounts of progestogens, was conducted at the Centro Medico Especializado em Planejamento Familiar in Rio Clara, Brazil. The study was designed to determine the differences in discontinuation rates between Norinyl 1/35 (Syntex) and Brevicon (Syntex) as well as the frequency of selected side effects which might contribute to method discontinuation. Both OCs contain 0.035 mg of ethinyl estradiol; Brevicon contains 0.5 mg and Norinyl 1/35 contains 1 mg norethindrone. Three-hundred women enrolled in the study were randomly assigned to either the Norinyl 1/35 or Brevicon OCs and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Intermenstrual bleeding was reported by significantly more women in the Brevicon group than in the Norinyl group (p less than 0.05), and significantly more Brevicon users reported an increase in intermenstrual bleeding. At the end of the study period, no differences were found between the two OC groups in terms of discontinuation rates, but a large number of women in each group discontinued for menstrual problems. The total discontinuation rates at 11 months for both groups were extremely high: 68.2 for the Norinyl 1/35 group and 75.2 for the Brevicon users. The largest group of discontinuations were comprised of those discontinuing for menstrual problems, other personal reasons, planned pregnancy and side effects.
Asunto(s)
Anticonceptivos Hormonales Orales , Etinilestradiol , Mestranol , Noretindrona , Adulto , Ensayos Clínicos como Asunto , Anticonceptivos Orales Combinados/efectos adversos , Anticonceptivos Hormonales Orales/efectos adversos , Combinación de Medicamentos , Etinilestradiol/efectos adversos , Femenino , Humanos , Mestranol/efectos adversos , Noretindrona/efectos adversos , Factores SocioeconómicosRESUMEN
Four-hundred-twenty-six women, aged 18 to 36, completed a four-cycle comparative, randomized, single-blind (observer blind), multicenter study of a new graduated estrogen formulation with three constant-dosed combination oral contraceptives containing the same synthetic steroid compounds. The products studied were Loestrin 1/20, Loestrin 1.5/30, Norlestrin 1/50, and a new graduated estrogen product, Estrostep. A total of 1,850 cycles were completed and analyzed for efficacy, side effects, metabolic changes, and cycle control. Four pregnancies occurred during the course of the study. None of the pregnancies occurred in the group receiving Estrostep. The new formulation produced the lowest rate of breakthrough bleeding (BTB) compared with the other three products. All four combination oral contraceptives resulted in an increase in high-density lipoprotein cholesterol (HDL-C). The levels of HDL-C were greatest with Estrostep.
Asunto(s)
Etinilestradiol/farmacología , Noretindrona/análogos & derivados , Noretindrona/farmacología , Adolescente , Adulto , Amenorrea/inducido químicamente , HDL-Colesterol/metabolismo , LDL-Colesterol/metabolismo , Ensayos Clínicos como Asunto , Anticonceptivos Orales Combinados/efectos adversos , Anticonceptivos Orales Combinados/farmacología , Combinación de Medicamentos , Etinilestradiol/efectos adversos , Femenino , Humanos , Noretindrona/efectos adversos , Embarazo , Hemorragia Uterina/inducido químicamenteRESUMEN
Two formulations of polylactic and polyglycolic acid microcapsules containing 75 and 100 mg of NET respectively were studied for a 90-day period of anticipated contraceptive effect in two groups of five women. A 200 mg dose of NET preparation was also studied for a 180-day period of anticipated contraceptive effect in 19 women. Alteration in menstrual cycle, with tendency to short bleeding episodes, spotting days, and amenorrhea were the most important collateral effects. In the majority of cases, ovulation was inhibited. No cases of pregnancy were presented. The obtained NET circulating levels were very stable during the period of anticipated contraceptive effect.
PIP: At the Institute of Scientific Investigation of Juarez University of Durango State in Mexico, clinical researchers compared three delivery systems of norethisterone (NET) contraceptive microspheres (biodegradable polymers [e.g., polyglycolic or polylactic acid] containing micronized crystals of NET). In the 6-month system, they injected 800 mg of microspheres containing 200 mg NET intramuscularly into 19 women and then monitored the women for various effects and side effects. Soon after injection, the mean NET level in serum rose to a peak value of about 3 ng/ml and then fell gradually until it was below 0.5 ng/ml at 25 weeks. No pregnancies occurred during this period. Estradiol levels remained well below 100 pg/ml, suggesting inhibition of follicular activity. However, one patient showed an elevation in estradiol at week 16. By 24 weeks, 4 of the 19 women showed signs of the return of follicular activity. Rises in progesterone levels, indicative of ovulation, were not seen in most women during the 6-month period. However, 4 women showed progesterone peaks followed by menstruation in weeks 4, 7, 17, and 23, suggesting that their cycles had begun to return before the end of the 6-month period. 35% of women reported dizziness and nausea. 26% reported nausea. A more serious concern was the disruption seen in the menstrual pattern. 13 women had bleeding and spotting, which continued for 8-30 days in 8 women. In the 3-month system, microspheres containing either 75 or 100 mg NET were injected, each into 5 women. NET levels rose to between 1 and 2 ng/ml and fell to 0.5 ng/ml by week 15. At week 25, they were undetectable. Levels of estradiol remained low for at least 15 weeks as did serum progesterone. No pregnancies occurred. One woman ovulated in week 17. Although no headache, dizziness, and nausea were reported, many of the same disruptions in the menstrual cycle reported in the 6-month study were observed, particularly prolonged cycles, amenorrhea, and spotting. Based on these findings, the researchers deemed the 100 mg for 3 months to be the most safe and effective formulation.
Asunto(s)
Anticoncepción , Noretindrona/administración & dosificación , Estradiol/sangre , Femenino , Humanos , Inyecciones Intramusculares , Menstruación/efectos de los fármacos , Microesferas , Noretindrona/efectos adversos , Noretindrona/farmacología , Ovario/efectos de los fármacos , Ovario/fisiología , Embarazo , Progesterona/sangreRESUMEN
PIP: 3 groups of IUD users participated in a preliminary study to evaluate the effect of calcium lonazolac, a nonsteroid antiinflammatory agent, on excessive menstrual bleeding. All participants were parous women aged 20-30 years in good health. Multiload 250 IUDs were inserted in 15 women averaging 24.5 years of age. They were also supplied with calcium lonazolac tablets in 200 mg doses to be taken continuously 3 times daily. 15 women averaging 26.1 years also had multiload 250 IUDs inserted. They were given the same instructions but their medication was a placebo. A third group of 30 women averaging 26.2 years of age who had experienced heavy bleeding during 6-36 months of IUD use were given 200 mg tablets of calcium lonazolac to be taken 3 times daily. The 30 women used various types of IUDs. All 60 women were provided with sanitary pads to be returned at their regular clinic visits. Hemoglobin and hematocrit levels were also determined at each visit. The method of Hallberg and Nilsson was used to measure menstrual blood loss. There were no significant changes in the volume or duration of bleeding or hemoglobin or hematocrit levels in the 15 women given the drug. The 15 women given the placebo had a significant increase in the quantity of blood loss and a significant increase in the duration bleeding in the 3rd month. The 30 women with histories of heavy bleeding had significant decreases in volume and duration of bleeding. Modifications in hemoglobin were not especially significant, while the hematocrit levels increased in the 2nd and 3rd months. None of the women reported significant side effects except 1 woman with a prior history of gastritis. Her gastric distress was controlled by an antacid after meals for 1 week. Comparison of results between the treated and control groups suggests that calcium lonazolac gives good results. Its use should be evaluated at lower doses with consumption limited to days of bleeding only.^ieng
Asunto(s)
Dispositivos Intrauterinos/efectos adversos , Metrorragia/tratamiento farmacológico , Antagonistas de Prostaglandina/uso terapéutico , Pirazoles/uso terapéutico , Hemorragia Uterina/tratamiento farmacológico , Adulto , Evaluación de Medicamentos , Femenino , Humanos , Metrorragia/etiología , Hemorragia Uterina/etiologíaRESUMEN
PIP: Despite the existence of 2 government health centers in Mexico's San Francisco township, the use of herbal remedies for the treatment of reproductive health problems and the management of reproduction is almost universal. An ethnographic study conducted in 1980-1981 of 180 women and 126 women investigated use of specific herbal remedies in this highland area. The largest number of reproduction-related medicinal plants used San Francisco are for postpartum recovery. In fact, 80% of the women interviewed reported using only herbal remedies after their last delivery. These remedies are relied on to restore lost blood, heal the birth scar, and stop bleeding. Of the 40% of respondents who reported postpartum hemorrhaging, 70% used herbal remedies. Several of the plants used to treat menorrhagia and hemorrhaging are also used for infertility. The infertility remedies are believed to cleanse the blood and uterus, heal or strengthen the back so the fetus can adhere, help the womb retain the fetus, and cool the blood. Both infertility and miscarriage are attributed to incomplete postpartum recovery. Another large group of medicinal remedies is employed to speed labor or ease labor pains. These remedies are thought to stimulate blood flow or uterine contractions. An additional 15 plants are used to prevent or terminate pregnancy. The mechanism of action in these case is believed to be to both warm the blood to facilitate its flow and irritate the uterus so it will evacuate its contents. Reliance on these remedies derives from Chinantec ethnomedical understandings. Given the persistence of use of herbal remedies in many communities in the Third World, research is needed on their safety and efficacy.^ieng
Asunto(s)
Abortivos , Recolección de Datos , Servicios de Planificación Familiar , Infertilidad , Medicina Tradicional , Menorragia , Plantas Medicinales , Periodo Posparto , Embarazo , Autocuidado , Aborto Inducido , Américas , Atención a la Salud , Países en Desarrollo , Enfermedad , Salud , Servicios de Salud , América Latina , Medicina , Trastornos de la Menstruación , México , América del Norte , Reproducción , Investigación , Muestreo , TerapéuticaRESUMEN
PIP: 50 women undergoing tubal sterilization by the modified Pomeroy technique at a hospital in Toluca, Mexico, were selected at random and followed for 6 months postoperative to detect changes in menstrual patterns. The women had normal menstrual histories and had not used contraceptive medications for at least 3 months prior to operation. Analgesia was provided by peridural block with 2% lidocaine. There were 45 cases of interval and 5 of immediate postpartum sterilization. The women ranged in age from 25 to 44 years and averaged 34.5.16 women, or 32%, had altered menstrual patterns. There were 12 cases of hypermenorrhea and 1 each of oligomenorrhea, polymenorrhea, amenorrhea, and proiomenorrhea. Age at menarche, parity, and obstetric history were unrelated to menstrual changes. Changes in menstrual patterns after surgical tubal occlusion have been attributed to damage in the uterine and ovarian blood vessels leading to reduced blood supply and ultimately to abnormal maturation of ovarian follicles and hormonal changes. Psychogenic factors may play a role. The extent of surgical damage after various techniques of tubal occlusion and the materials used for suturing should be assessed as possible sources of local or regional inflammation that could have repercussions in blood perfusion and nervous function.^ieng
Asunto(s)
Trastornos de la Menstruación/etiología , Esterilización Tubaria/efectos adversos , Adulto , Femenino , Hormonas Esteroides Gonadales/biosíntesis , Humanos , Menorragia/etiología , Menorragia/fisiopatología , Trastornos de la Menstruación/fisiopatología , Persona de Mediana Edad , Ovario/irrigación sanguínea , Ovario/inervación , Útero/irrigación sanguíneaRESUMEN
PIP: A literature review was undertaken of clinical stuides to determine the frequency of menstrual alterations or various psychosocial effects after surgical tubal sterilization. The most frequently mentioned symptoms following bilateral salpingocalsy or salpingectomy are increased menstrual blood loss, dysmenorrhea, dispareunia, pelvic pain, oligemenorrhea, polymenorrhea, and preclimacteric syndrome in some cases. Uribe and colleagues attributed the high frequency of abdominal pain in tubal occlusions achieved with mechanical devices such as rings to the compression pain produced by uncut nerve edings, which do not occur with electrocoagulation or the Pomeroy technique. Alderman and colleagues found that only 6.5% of their patients experienced increased menstrual flow after sterilization, but Rioux found confirmation of menstrual changes to be difficlut and Chamberlain reported change in 2.6-51% of patients, perhaps related to previous use of contraceptives. Radwanska and colleagues found that patients sterilized by electrocoagulation or tubal ligation had a lower average level of serum progesterone in the midluteal cycle phase, 9.4 +or- 4.7 ng/ml compared to 17.4 +or- 7.1 ng/ml for controls. Donnez found that patients sterilized by electrofulguration had an average of 8.5 +or- 6 ng/ml of progesterone in the midluteal phase compared to 15.4 +or- 6.3 ng/ml for those sterilized using Hulka clips. The largest proportion of women with menstrual alterations or pain were younger, lower parity women who were sterilized for medical reasons. Menstrual changes and pelvic symptoms following sterilization are subjective and difficult to evaluate. Some authors cite the rarity of longterm sequelae of sterilization, but others used radioimmunoassay techniques to demonstrate changes in serum progesterone levels that may be linked to alterations in function of the ovaries or corpus luteum following sterilization. Other authors believe that most negative sequelae could be minimized or eliminated with better patient selection and counseling.^ieng
Asunto(s)
Trastornos de la Menstruación/etiología , Esterilización Tubaria/efectos adversos , Electrocoagulación/efectos adversos , Estradiol/análisis , Femenino , Humanos , Ligadura/efectos adversos , Progesterona/análisis , Prolactina/análisisRESUMEN
PIP: The insertion of intrauterine devices (IUDs) in nulliparous women is a controversial subject, with no unanimous opinion on whether or not to use this method. A study was undertaken to analyze retrospectively the complications of the TCu-200 IUD in nulliparous women compared to complications encountered in multiparous women using the same device. In 1982 and 1983, the Family Planning and Human Reproduction Clinic of the UFMG Medical School in Belo Horizonte, Brazil, inserted 114 IUDs in nulliparas. The principle characteristics of the study group were a low socioeconomic condition, regularity of menstrual flow, and absence of vaginal infection at the time of examination. The choice of method was the spontaneous decision of the women. It was noted that nulliparas requested IUD insertion after previous unsatisfactory experience with other contraceptive methods. 56% of the group were single and 38% married. For comparison, 300 records of multiparous TCU-200 IUD users were studied retrospectively. All insertions were made by the same clinic. The racial, social, and economical characteristics were typical of the users of any free family planning service. Among early complications, pain and lipothymia were encountered at an elevated incidence in nulliparous women when compared to multiparas (p0.01). Among late complications, the appearance of vaginal discharge and metrorrhagia were significant when compared to multiparas (p0.05). Pelvic infection and dysmenorrhea, although more frequent in nulliparas, were not statistically significant. The authors concluded that the IUD should not be used as the contraceptive method of 1st choice in nulliparous women, using it only in exceptional situations.^ieng