RESUMO
OBJECTIVE: To evaluate the influence of estrogen therapy and estrogen-progestin therapy on homocysteine and C-reactive protein levels in postmenopausal women. METHODS: In total, 99 postmenopausal women were included in this double-blind, randomized clinical trial and divided into three groups: Group A used estrogen therapy alone (2.0 mg of 17ß-estradiol), Group B received estrogen-progestin therapy (2.0 mg of 17 ß-estradiol +1.0 mg of norethisterone acetate) and Group C received a placebo (control). The length of treatment was six months. Serum measurements of homocysteine and C-reactive protein were carried out prior to the onset of treatment and following six months of therapy. RESULTS: After six months of treatment, there was a 20.7% reduction in homocysteine levels and a 100.5% increase in C-reactive protein levels in the group of women who used estrogen therapy. With respect to the estrogen-progestin group, there was a 12.2% decrease in homocysteine levels and a 93.5% increase in C-reactive protein levels. CONCLUSION: Our data suggested that hormone therapy (unopposed estrogen or estrogen associated with progestin) may have a positive influence on decreasing cardiovascular risk due to a significant reduction in homocysteine levels.
Assuntos
Proteína C-Reativa/metabolismo , Terapia de Reposição de Estrogênios/métodos , Estrogênios/uso terapêutico , Homocisteína/sangue , Pós-Menopausa/sangue , Progestinas/uso terapêutico , Fatores Etários , Brasil , Doenças Cardiovasculares/prevenção & controle , Método Duplo-Cego , Combinação de Medicamentos , Estradiol/administração & dosagem , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Pessoa de Meia-Idade , Noretindrona/administração & dosagem , Noretindrona/análogos & derivados , Acetato de Noretindrona , Pacientes Desistentes do Tratamento , Estudos ProspectivosRESUMO
OBJECTIVE: To evaluate the influence of estrogen therapy and estrogen-progestin therapy on homocysteine and C-reactive protein levels in postmenopausal women. METHODS: In total, 99 postmenopausal women were included in this double-blind, randomized clinical trial and divided into three groups: Group A used estrogen therapy alone (2.0 mg of 17β-estradiol), Group B received estrogen-progestin therapy (2.0 mg of 17 β-estradiol +1.0 mg of norethisterone acetate) and Group C received a placebo (control). The length of treatment was six months. Serum measurements of homocysteine and C-reactive protein were carried out prior to the onset of treatment and following six months of therapy. RESULTS: After six months of treatment, there was a 20.7% reduction in homocysteine levels and a 100.5% increase in C-reactive protein levels in the group of women who used estrogen therapy. With respect to the estrogen-progestin group, there was a 12.2% decrease in homocysteine levels and a 93.5% increase in C-reactive protein levels. CONCLUSION: Our data suggested that hormone therapy (unopposed estrogen or estrogen associated with progestin) may have a positive influence on decreasing cardiovascular risk due to a significant reduction in homocysteine levels. .
Assuntos
Feminino , Humanos , Pessoa de Meia-Idade , Proteína C-Reativa/metabolismo , Terapia de Reposição de Estrogênios/métodos , Estrogênios/uso terapêutico , Homocisteína/sangue , Pós-Menopausa/sangue , Progestinas/uso terapêutico , Fatores Etários , Brasil , Doenças Cardiovasculares/prevenção & controle , Método Duplo-Cego , Combinação de Medicamentos , Estradiol/administração & dosagem , Seguimentos , Estudos Longitudinais , Noretindrona/administração & dosagem , Noretindrona/análogos & derivados , Pacientes Desistentes do Tratamento , Estudos ProspectivosRESUMO
OBJECTIVE: To compare the effects of the abrupt discontinuation of postmenopausal hormone therapy (HT) and reduction of the daily dosage of the hormone on climacteric symptoms. METHODS: The study included Brazilian postmenopausal women who were using estrogen-progestogen hormone therapy in full doses previously prescribed for vasomotor symptoms. The patients were randomized to receive one of three treatments: placebo for 6 months; estradiol (E2) 1 mg/day + norethisterone acetate (NETA) 0.5 mg/day for 2 months, followed by placebo for 4 months; or E2 1 mg/day + NETA 0.5 mg/day for 4 months, followed by placebo for 2 months. The climacteric symptoms were assessed by the Blatt-Kupperman Menopausal Index at baseline and at 2, 4 and 6 months. Statistical evaluation was performed using the chi(2) or Fisher's test for categorical data, the Kruskal-Wallis test for numerical data, and ANOVA for time and group relationship with the Blatt-Kupperman Menopausal Index. RESULTS: We randomized 60 women (20 in each group), and 54 completed the study. It was observed that both the full Blatt-Kupperman Menopausal Index and the hot flush score did not change significantly in the HT group during low-dose therapy compared with baseline; however, the evaluation performed at 2 months after low-dose-HT cessation showed that the full Blatt-Kupperman Menopausal Index and the hot flush score were similar to those of the group who stopped HT abruptly and significantly higher than at baseline (hot flush scores: p < 0.001 for all three groups at months 2, 4 and 6, respectively, vs. baseline). CONCLUSION: Discontinuation of HT by reducing the daily dose of estrogen for a period of 2 or 4 months did not differ in its effect from that of abrupt cessation with regard to vasomotor symptoms.
Assuntos
Estradiol/administração & dosagem , Terapia de Reposição de Estrogênios/métodos , Fogachos/epidemiologia , Feminino , Fogachos/tratamento farmacológico , Humanos , Pessoa de Meia-Idade , Noretindrona/administração & dosagem , Noretindrona/análogos & derivados , Acetato de Noretindrona , Placebos , Fatores de TempoRESUMO
STUDY OBJECTIVE: To compare in a regular non-clinical trial experience the efficacy, acceptability, and continuation rates of an injectable contraceptive containing 50 mg norethisterone enanthate plus 5mg estradiol valerate (IC) and an oral contraceptive containing 0.15 mg levonorgestrel plus 0.03 mg ethinyl estradiol (OC), among adolescent users. DESIGN: A total of 251 adolescents ages 14-19 were followed during 12 months. The IC group (124 subjects) was studied for 1044 cycles and the OC group (127 subjects) was studied for 1368 cycles. The users were not assigned in a random selection. Information was collected from clinical records. Groups were compared using Pearson chi-square, odds ratio (95% confidence interval), t-test, and proportion difference test. RESULTS: The IC group had significant differences in baseline social risk, confidence, psychiatric problems, consumption of alcohol, and number of sexual partners. At 12 months, the IC group showed significant decrease in weight and increase in hypermenorrhea. In the OC group, dysmenorrhea decreased, and hypomenorrhea and regular cycles were significantly more frequent. One pregnancy occurred in the OC group (Pearl Index: 0.88). Final continuation rates at 12 months were 41.9% and 37.8% for IC and OC, respectively. CONCLUSIONS: The monthly injectable is a recommended contraceptive option for adolescents, especially for those facing psychosocial risk factors.
Assuntos
Anticoncepcionais Orais Combinados/administração & dosagem , Estradiol/análogos & derivados , Adesão à Medicação , Noretindrona/análogos & derivados , Adolescente , Instituições de Assistência Ambulatorial , Anticoncepcionais Orais Combinados/efeitos adversos , Esquema de Medicação , Combinação de Medicamentos , Estradiol/administração & dosagem , Estradiol/efeitos adversos , Etinilestradiol/administração & dosagem , Etinilestradiol/efeitos adversos , Feminino , Humanos , Injeções Intramusculares , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Noretindrona/administração & dosagem , Noretindrona/efeitos adversos , Satisfação do Paciente , Estudos Prospectivos , Adulto JovemRESUMO
OBJECTIVES: To determine the effects of low-dose transdermal hormone therapy (HT) on systolic (SBP) and diastolic (DBP) blood pressure (BP) evaluated by 24-h ambulatory blood pressure monitoring (ABPM) in hypertensive postmenopausal women. METHODS: The study was conducted on 24 hypertensive postmenopausal women aged, on average, 54 years and under treatment with enalapril maleate (10-20 mg/day) combined or not with hydrochlorothiazide (25 mg/day). Thirteen women used a transdermal adhesive containing estradiol and norethisterone (25 and 125 mug active substance/day, respectively) and 11 did not receive HT. ABPM, lipid profile, and climacteric symptoms were evaluated before and 3 and 6 months after treatment. RESULTS: After 3 and 6 months of follow-up, there was a statistically significant reduction of the Blatt-Kupperman menopausal index in the treated group (19.6+/-8.3 vs. 9.6+/-5.9 vs. 9.7+/-7.0; P=0.01). No significant difference in any of the ABPM variables (areas under the systolic and diastolic curves, mean SBP and DBP, SBP and DBP loads and wakefulness-sleep variation) or in the lipid profile was observed between or within groups at the three time points studied. CONCLUSION: Low-dose transdermal HT administered for 6 months was effective in improving climacteric symptoms and did not change BP values or circadian pattern in postmenopausal women with mild-to-moderate arterial hypertension taking antihypertensive medications.
Assuntos
Anti-Hipertensivos/uso terapêutico , Estradiol/administração & dosagem , Terapia de Reposição de Estrogênios , Hipertensão/tratamento farmacológico , Noretindrona/administração & dosagem , Administração Cutânea , Monitorização Ambulatorial da Pressão Arterial , Estudos de Casos e Controles , Estudos de Coortes , Relação Dose-Resposta a Droga , Interações Medicamentosas , Estradiol/efeitos adversos , Feminino , Humanos , Menopausa , Pessoa de Meia-Idade , Noretindrona/efeitos adversos , Projetos PilotoRESUMO
OBJECTIVE: To evaluate the correlation between homocysteine levels and carotid vascular resistance in menopausal women submitted to estrogen and estrogen-progestogen therapy. METHODS: Eighty-six women with a mean age of 52 years were enrolled in a prospective, randomized, double-blind, 6-month study. Patients were allocated to use one of three oral therapies: placebo (n = 26), micronized estradiol 2 mg/day (n = 30) or micronized estradiol 2 mg/day plus norethisterone acetate 1 mg/day (n = 30). Evaluation of homocysteine levels and Doppler sonography of the common carotid artery, used to calculate pulsatility index (PI), were carried out prior to initiating therapy and at the end of the study. The correlation between these two parameters was evaluated using Pearson's coefficient of correlation. RESULTS: There was a significant reduction in homocysteine levels in the groups treated with estrogen alone or estrogen combined with norethisterone. PI was significantly lower only in users of estrogen alone; however, no significant correlation was found between homocysteine measurements and PI. CONCLUSION: No significant correlation was found between homocysteine levels and carotid vascular resistance following hormone therapy.
Assuntos
Artéria Carótida Primitiva/fisiologia , Estradiol/administração & dosagem , Homocisteína/sangue , Menopausa , Noretindrona/análogos & derivados , Artéria Carótida Primitiva/diagnóstico por imagem , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Noretindrona/administração & dosagem , Acetato de Noretindrona , Placebos , Estudos Prospectivos , Fluxo Pulsátil , Ultrassonografia , Resistência VascularRESUMO
PURPOSE: This prospective noncomparative observational study evaluated the clinical symptoms, body weight and blood pressure of 38 adolescents receiving a monthly injectable contraceptive containing estradiol valerate 5 mg and norethisterone 50 mg. METHODS: The volunteers, aged 16-19 years, were examined monthly during 1 year and asked about the following symptoms at baseline: dysmenorrhea, headache, breast tenderness, leg pain and irritability. RESULTS: There was a constant and gradual decline in each of the above symptoms over time, and there was a statistically significant difference between symptoms reported at the first visit and subsequent appointments. Body weight and blood pressure did not change significantly during the 1-year period. No pregnancies were observed. CONCLUSION: These findings suggest that monthly injectable contraception with estradiol valerate 5 mg/norethisterone 50 mg represents a highly effective and well-tolerated contraceptive for teens.
Assuntos
Anticoncepcionais Femininos/administração & dosagem , Estradiol/análogos & derivados , Noretindrona/administração & dosagem , Adolescente , Serviços de Saúde do Adolescente , Peso Corporal , Brasil , Anticoncepcionais Femininos/efeitos adversos , Esquema de Medicação , Estradiol/administração & dosagem , Estradiol/efeitos adversos , Feminino , Humanos , Injeções Intramusculares , Noretindrona/efeitos adversos , Estudos ProspectivosRESUMO
BACKGROUND: Arterial hypertension and postmenopausal reduction of estrogen levels may be involved in modifications of the stiffness of large arteries. OBJECTIVES: To evaluate the pulse-wave velocity (PWV) and indirectly the arterial stiffness in hypertensive postmenopausal women submitted to hormone therapy with estradiol alone or combined with norethisterone acetate. SUBJECTS: Forty-five hypertensive postmenopausal women were double-blindly, randomly assigned to three arms of treatment: placebo (group I); estradiol 2 mg/day (group II); or estradiol 2 mg/day and norethisterone acetate 1 mg/day (group III). METHODS: Arterial stiffness was assessed from PWV measurements of the common carotid and femoral arteries (CF-PWV) and the common carotid and radial arteries (CR-PWV) obtained using the automatic Complior(R) device, taken at baseline and after 12 weeks of treatment. RESULTS: After the 12-week treatment, values of CF-PWV and CR-PWV were not significantly different (p = 0.910 and p = 0.736, respectively) among the groups. Systolic blood pressure showed a positive correlation with CF-PWV in groups II and III (p = 0.02 and p < 0.001, respectively). CONCLUSIONS: PWV and arterial stiffness in postmenopausal hypertensive women did not reduce over a 12-week treatment with estradiol alone compared with the same period of treatment with estradiol combined with norethisterone acetate.
Assuntos
Velocidade do Fluxo Sanguíneo/efeitos dos fármacos , Estradiol/farmacologia , Hipertensão/fisiopatologia , Noretindrona/análogos & derivados , Pós-Menopausa/efeitos dos fármacos , Pulso Arterial , Pressão Sanguínea/efeitos dos fármacos , Artérias Carótidas/fisiopatologia , Método Duplo-Cego , Combinação de Medicamentos , Estradiol/administração & dosagem , Feminino , Humanos , Hipertensão/sangue , Pessoa de Meia-Idade , Noretindrona/administração & dosagem , Noretindrona/farmacologia , Acetato de Noretindrona , Placebos , Pós-Menopausa/sangue , Resistência Vascular/efeitos dos fármacosRESUMO
OBJECTIVE: The objective of this descriptive study was to compare bone mineral density (BMD) between users of two kinds of once-a-month combined injectable contraceptives (CICs) and control subjects. SUBJECTS AND METHODS: This cross-sectional descriptive study included 97 women aged between 20 and 45 years using CICs containing either 25 mg of medroxyprogesterone acetate and 5 mg of estradiol cypionate for 12-82 months or 50 mg of norethindrone enanthate and 5 mg of estradiol valerate for 12-60 months, matched by age (+/-1 year) and body mass index (BMI; kg/m(2)) (+/-1) with users of the TCu 380A intrauterine device as control subjects. BMD was evaluated at the midshaft of the ulna and at the distal section of the radius of the nondominant forearm using double X-ray absorptiometry. RESULTS: There was no difference in BMD between users of either CIC and nonusers at either section of the forearm studied. There was also no difference in BMD between users of the two CICs at either section of the forearm. CONCLUSIONS: Women aged between 20 and 45 years, currently using one of these two kinds of CICs, presented BMDs similar to those of control subjects paired by age and BMI.
Assuntos
Densidade Óssea , Anticoncepcionais Femininos/administração & dosagem , Absorciometria de Fóton , Adulto , Índice de Massa Corporal , Estudos Transversais , Estradiol/administração & dosagem , Estradiol/análogos & derivados , Feminino , Humanos , Injeções , Acetato de Medroxiprogesterona/administração & dosagem , Noretindrona/administração & dosagem , Noretindrona/análogos & derivados , Rádio (Anatomia) , UlnaRESUMO
PURPOSE: This prospective observational study evaluated the bleeding patterns of adolescents receiving a monthly injectable contraceptive containing norethisterone enanthate 50 mg plus estradiol valerate 5 mg. MATERIALS AND METHODS: The study enrolled 73 volunteers aged between 14 and 19 years; of these patients, 38 (52%) recorded their menstrual cycles during 1 year. RESULTS: After 1 year of using the contraceptive, most of the 38 women (71.1%) had adequate menstrual patterns (two to four bleeding episodes; none lasting 10 days or longer; with a range of bleeding-free intervals not exceeding 17 days), 23.7% reported prolonged bleeding episodes, 2.6% had irregular bleeding and 2.6% had amenorrhea. Only 1 of the 38 teenagers is known to have discontinued the method due to bleeding. Among these 38 adolescents, dissatisfaction with bleeding patterns was not a frequent reason given for discontinuation of the monthly injectable contraceptive.
Assuntos
Anticoncepcionais Femininos/administração & dosagem , Estradiol/análogos & derivados , Menstruação/efeitos dos fármacos , Noretindrona/análogos & derivados , Adolescente , Adulto , Anticoncepcionais Femininos/efeitos adversos , Combinação de Medicamentos , Estradiol/administração & dosagem , Feminino , Humanos , Injeções Intramusculares , Distúrbios Menstruais/induzido quimicamente , Noretindrona/administração & dosagem , Cooperação do Paciente , Estudos ProspectivosRESUMO
OBJECTIVE: To evaluate changes in mammographic density and (99m)Tc-sestamibi scintimammographic uptake in postmenopausal women on hormone replacement therapy (HRT). METHODS: Seventy-five postmenopausal women were prospectively studied and allocated into three groups: 50 women were randomized to either Group 1 (G1, n=25), which received 2mg of 17beta-oestradiol continuously combined with 1mg of norethisterone acetate (E2/NETA, Kliogest, Medley) or Group 2 (G2), which received 2.5mg/day of tibolone (Livial, Organon). The remaining 25 women, who were asymptomatic and had no desire to undergo HRT, constituted the control group (G3). Each patient was submitted to both mammography and scintimammography at baseline and after six months. Mammographic density was evaluated by using the BI-RADS classification system. The classification system of Barros et al. was used in the interpretation of scintimammography. For statistical analysis, the Chi-square test, ANOVA and Pearson's correlation were used. RESULTS: At six months, increased mammographic density was observed in 48% of G1, 12% of G2 and 16% of G3 patients (p<0.001). The increase in sestamibi uptake was 56% in G1, 28% in G2 and 24% in G3 (p<0.001). Increases in both density and uptake were significantly higher in the group on E2/NETA than among tibolone users and the controls. CONCLUSION: In postmenopausal women, HRT with E2/NETA was associated with increased mammographic density and increased (99m)Tc-sestamibi scintimammographic uptakes, suggesting greater mithochondrial activity in the cells of the mammary duct. This was not observed in users of 2.5 mg of tibolone, demonstrating that the effects on the breast were reduced. The same was observed in the control group.
Assuntos
Mama/efeitos dos fármacos , Estradiol/farmacologia , Moduladores de Receptor Estrogênico/farmacologia , Terapia de Reposição de Estrogênios/métodos , Noretindrona/análogos & derivados , Norpregnenos/farmacologia , Mama/diagnóstico por imagem , Distribuição de Qui-Quadrado , Estradiol/administração & dosagem , Moduladores de Receptor Estrogênico/administração & dosagem , Feminino , Seguimentos , Humanos , Mamografia , Pessoa de Meia-Idade , Noretindrona/administração & dosagem , Noretindrona/farmacologia , Acetato de Noretindrona , Norpregnenos/administração & dosagem , Pós-Menopausa , Estudos Prospectivos , CintilografiaRESUMO
The objectives of this study were to compare effects of medroxyprogesterone acetate 25 mg + estradiol cypionate 5 mg (Cyclofem) and norethisterone enanthate (NET-EN) upon the menstrual pattern and determine changes in lipoprotein parameters after 12 months of use. One-hundred females were included and 87 (45 with Cyclofem and 42 with NET-EN) women completing 12 months were evaluated. Menstrual changes were the leading complaint among users. At the end of 12 months, 20/45 (44.4%) and 18/41 (43.9%) Cyclofem and NET-EN users, respectively, had normal menstrual pattern. Irregular and infrequent bleeding were the two most important changes that occurred. The discontinuation rate at 12 months due to menstrual disturbances did not show any significant differences between the two preparations, but showed lower incidence compared to other studies. Total cholesterol, high-density, low-density and very low-density lipoprotein cholesterol and triglyceride levels decreased at 12 months in both groups and these changes were statistically significant.
Assuntos
Anticoncepcionais Femininos/efeitos adversos , Anticoncepcionais Orais Combinados/efeitos adversos , Estradiol/análogos & derivados , Estradiol/efeitos adversos , Lipídeos/sangue , Acetato de Medroxiprogesterona/efeitos adversos , Distúrbios Menstruais/induzido quimicamente , Noretindrona/análogos & derivados , Noretindrona/efeitos adversos , Adolescente , Adulto , Colesterol/metabolismo , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Orais Combinados/administração & dosagem , Combinação de Medicamentos , Estradiol/administração & dosagem , Feminino , Humanos , Injeções Intramusculares , Acetato de Medroxiprogesterona/administração & dosagem , Distúrbios Menstruais/prevenção & controle , Pessoa de Meia-Idade , Noretindrona/administração & dosagemRESUMO
Muitas investigações relatam maior prevalência na Doença Cardiovacular (DCV), no período após a menopausa, e dentre as DCV está a hipertensão arterial (HA). O aumento crônico da pressão arterial e as flutuações nas concentrações séricas dos estrogênios exercem importante impacto sobre a parede arterial resultando em perturbação, na elasticidade e rigidez arterial (RA). Por isso, avaliou-se a rigidez arterial, em 45 mulheres hipertensas após menopausa / High prevalence of Cardiovascular Disease (CVD) has been frequently reported in postmenopausal women, among the CVDs is the arterial hypertension. It is well know that chronic high arterial pressure (AP) and the fluctuation in estrogen serum levels exert a critical impact on the arterial wall, resulting in disturbances in elasticity and stiffness. Therefore, the goal of this study was to evaluate the arterial stiffness (AS) ,in 45 hypertensive postmenopausal women...
Assuntos
Humanos , Feminino , Doenças Cardiovasculares/patologia , Estradiol/administração & dosagem , Pós-Menopausa , Hipertensão/patologia , Morbidade , Noretindrona/administração & dosagem , Placebos/administração & dosagem , Pressão ArterialRESUMO
OBJECTIVE: To determine the effects of hormone replacement therapy on plasma concentrations of free and total insulin-like growth factor (IGF)-I, IGF binding protein (BP)-1, and IGFBP-3. DESIGN: Clinical study. SETTING: Gynecologic clinic at a university hospital. PATIENT(S): Seventy-one postmenopausal women. INTERVENTION(S): Six cycles of four different hormonal replacement therapy regimens: oral conjugated estrogens, transdermal estradiol, oral conjugated estrogens and norethisterone, and transdermal estradiol and norethisterone acetate. MAIN OUTCOME MEASURE(S): Blood samples were collected before and after treatment for measurement of free and total IGF-I, IGFBP-1, and IGFBP-3. RESULT(S): Conjugated estrogen replacement therapy is associated with a decrease in plasma concentration of total IGF-I and increase in concentrations of free IGF-I and IGFBP-1. Transdermal estrogens have no effect on total and free IGF-I and IGFBP-1 concentrations. Oral norethisterone plus conjugated estrogens increased free IGF-I and IGFBP-1 concentrations but did not change IGF-I concentrations. Transdermal conjugated estrogens plus norethisterone acetate increased free IGF-I concentrations but not total IGF-I or IGFBP-1 concentrations. The plasma concentration of IGFBP-3 did not change in any group. CONCLUSION(S): Alterations in total IGF-I concentration can occur depending on the route of hormone replacement therapy administration. Free IGF-I concentrations were elevated in all study groups except that treated with transdermal estrogens.
Assuntos
Terapia de Reposição de Estrogênios/efeitos adversos , Proteína 1 de Ligação a Fator de Crescimento Semelhante à Insulina/sangue , Proteína 3 de Ligação a Fator de Crescimento Semelhante à Insulina/sangue , Fator de Crescimento Insulin-Like I/análise , Pós-Menopausa , Administração Cutânea , Administração Oral , Glicemia/análise , Estrogênios/administração & dosagem , Estrogênios Conjugados (USP)/administração & dosagem , Feminino , Humanos , Insulina/sangue , Noretindrona/administração & dosagemRESUMO
OBJECTIVE: This randomized, double-blind, multicenter study was planned to compare the efficacy and tolerance of a novel oral regimen containing estradiol (2.0 mg) sequentially combined with trimegestone, at a daily dose of either 0.25 mg or 0.5 mg, with a standard hormone replacement therapy containing estradiol and norethisterone acetate (E2 + NETA) in the treatment of climacteric symptoms. METHODS: The study was conducted over 13 cycles, each of 28 days, and involved 487 subjects, of whom 349 completed the study. RESULTS: All three treatments were equally effective in alleviating hot flushes and showed a progressive and significant reduction in the value of the Kupperman index. The treatments diminished equally effectively urogenital signs and symptoms. All treatments were well tolerated and the incidences of adverse events associated with each treatment were similar across the treatment groups. The duration of expected withdrawal bleeding was shorter in the estradiol + trimegestone 0.5 mg group than in the estradiol + trimegestone 0.25 mg or E2 + NETA group. CONCLUSION: All treatments were effective and well tolerated, providing significant relief from climacteric symptoms. Treatment with estradiol + trimegestone 0.5 mg provided the most favorable bleeding pattern.
Assuntos
Estradiol/uso terapêutico , Terapia de Reposição de Estrogênios , Fogachos/tratamento farmacológico , Noretindrona/análogos & derivados , Noretindrona/uso terapêutico , Promegestona/uso terapêutico , Hemorragia Uterina/fisiopatologia , Argentina , Método Duplo-Cego , Endométrio/efeitos dos fármacos , Endométrio/patologia , Estradiol/administração & dosagem , Estradiol/farmacologia , Europa (Continente) , Feminino , Humanos , Pessoa de Meia-Idade , Noretindrona/administração & dosagem , Noretindrona/farmacologia , Acetato de Noretindrona , Satisfação do Paciente , Promegestona/administração & dosagem , Promegestona/análogos & derivados , Promegestona/farmacologia , Resultado do TratamentoRESUMO
Introducción. La 5Ó-Noretisterona (5Ó-NET) es un metabolito sintético que tiene alta afinidad por el receptor de progesterona e inhibe la acción de este esteroide natural. En conejas gestantes se demostró que la administración de este compuesto durante los primeros días post-coito inhibe tanto la implantación del ovocito como la actividad del Factor de Embarazo Temprano (FET), dicho factor es producido por el ovocito una vez que se ha llevado a cabo la fertilización. Sin embargo, en éstos trabajos no desmuestran si este compuesto ejerce acciones deletéreas sobre el ovocito en desarrollo, previas a la implantación. Objetivo. Analizar el efecto in vitro e in vivo de 5Ó-NET sobre el desarrollo del ovocito desde la etapa post-fertilización hasta la formación de la mórula. Material y métodos. Los gametos fueron obtenidos de ratones hembras de la cepa Balb/C y de machos C57BL/6J. La fertilización se llevó a cabo tanto in vitro como in vivo utilizando técnicas previamente descritas, con algunas modificaicones. Una vez que se observó la formación de los cuerpos polares, se inició la administración de 5Ó-NET a diferentes dosis al medio de cultivo y se incubaron a 37ºC, 5 por ciento CO2 y 95 por ciento aire. Los cambios en la estructura y morfología fueron analizados a diferentes tiempos de incubación por microscopio de luz (400x). Un total de 153 ovocitos fueron analizados en el modelo in vivo y de 142 en los experimentos in vitro. En ambos casos el análisis estadístico se hizo mediante la prueba de x2 con Ó=0.05. Resultados. El análisis estadístico en ambos modelos muestra que la presencia de 5Ó-NET en el medio de cultivo ejerce efectos deletéreos sobre el desarrollo y morfología de los ovocitos fertilizados, reflejándose en la destrucción de los blastómeros y la aparición de granulaciones en su interior
Assuntos
Animais , Gravidez , Ratos , Blastômeros , Desenvolvimento Fetal/efeitos dos fármacos , Mórula , Noretindrona/administração & dosagem , ProgestinasRESUMO
OBJECTIVE: Oral contraceptives (OC) are the most efficient method of contraception and it is the most prescribed by doctors in developing countries. Therefore we studied the effects of combination pill and mini-pill on calcium and phosphorus in milk of breast-feeding mothers at different stages of lactation. METHODS: Fifty-four breast-feeding mothers made up three study groups: 33 mothers who had been advised by their doctors to use either combination pill (12), or mini-pill (21), as well as a control group of 21 mothers that used no hormonal contraceptives. All mothers completed a questionnaire and provided samples of milk before and after a measured period of observation. Mean duration of study was 76, 120, and 101 days, respectively for users of mini-pill, combination pill, and controls. Determination of calcium and phosphorus was done by inductively coupled plasma-atomic absorption spectrometry. RESULTS: Overall the decrease in milk concentrations of phosphorus (6%) and calcium (26.3%) during the study period was not influenced by OC treatment. Regression analyses which took into consideration length of treatment, socioeconomic status, number of children, duration of previous lactation, type of contraceptive, and age of mothers and repeated measurements (before and after OC) showed that milk calcium was significantly affected by stage of lactation (p=0.0013). CONCLUSION: The use of hormonal contraceptive such as the combination pill (levonorgestrel 0.15 mg+ethynilestradiol 0.03 mg) and mini-pill (norethindone 0.35 mg) does not seem to affect the secretion of calcium and phosphorus in milk of mothers.
PIP: This article is based on a study of the effects of oral contraceptives (OCs) on the concentration of calcium and phosphorus in breast milk among 54 lactating Brazilian women. Confounding constitutional variables were considered which include maternal age, previous lactation, length of breast-feeding, and variables associated with contraception, such as type and length of use. The subjects were divided into 3 groups: 12 using combination pills, 21 using mini-pills, and a control group of 21 mothers that used no hormonal contraceptives. Milk was sampled before and after a measured period of observation. The mean durations of study were 76, 120, and 101 days, respectively, for users of mini-pills, combination pills, and controls. The determination of calcium and phosphorous was done by inductively coupled plasma-atomic absorption spectrometry. The results indicate that a mean stage of lactation at start of treatment for the 3 groups ranged from 2.5 to 4 months. Both calcium and phosphorous declined in concentration with time, confounded with OC treatment. There was no significant difference for calcium concentration due to OC treatment, only stage of lactation, per se, was a significant source of variation for calcium concentration. As lactation progressed, the calcium and phosphorous concentration decreased for all mothers. Therefore, short-term use of OCs containing estrogen do not affect calcium and phosphorous concentrations in breast milk.
Assuntos
Cálcio/análise , Anticoncepcionais Orais/efeitos adversos , Lactação , Leite Humano/química , Fósforo/análise , Adolescente , Adulto , Anticoncepcionais Orais Combinados/efeitos adversos , Etinilestradiol/administração & dosagem , Etinilestradiol/efeitos adversos , Feminino , Humanos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Noretindrona/administração & dosagem , Noretindrona/efeitos adversos , Análise de RegressãoRESUMO
Injectable contraceptives are a valid option in every family planning program. Contraceptives which are administered every 2 or 3 months, containing only progestogen agents (DepoProvera, Noristerat) have proven efficacious and do not show long-term safety problems. They differ from other contraceptives in their long lasting action and by not presenting the contraindications of the estrogens. Their most prominent side-effect is the irregularity of cyclic bleeding. Although bleeding irregularities are not life threatening, many users stop the treatment for that reason. Monthly contraceptives comprising progestogens and estrogens, maintain or improve the high efficacy of the earlier forms and have the added benefit of allowing bleeding to resemble the physiologic one. This increases acceptability and the continuation rate. There is no long-term inconvenience. At this point, the greatest experience is with the formulation known as Topasel or Perlutal. Other formulations (Cyclofem, Mesigyna) are beginning to be commercialized and their characteristics must still be confirmed through daily use. Indications, contraindications, precautions and warnings for the use of monthly injectable contraceptives are basically identical to those of the combined oral contraceptives, as are the side-effects. Efficacy, though, proves to be superior, which can be correlated to a simpler method of use and less risk of error when using it. Main motivation factors are: efficacy, simplicity in usage, reversibility and confidentiality.
Assuntos
Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Feminino , Humanos , Injeções Intramusculares , Acetato de Medroxiprogesterona/administração & dosagem , Acetato de Medroxiprogesterona/efeitos adversos , Distúrbios Menstruais/induzido quimicamente , Noretindrona/administração & dosagem , Noretindrona/efeitos adversos , Noretindrona/análogos & derivados , GravidezRESUMO
A 24 weeks, randomized, two-period, placebo controlled study was conducted to compare the effects of continuous transdermal 17 beta-estradiol replacement therapy (0.05 mg/day once a week) with placebo on systemic hemodynamics and blood pressure in postmenopausal women. Twenty-nine postmenopausal women (47-62 years) free of hormone replacement therapy were randomized in two groups; group 1 received estradiol patches for the first 12 weeks and placebo patches for the second, and group 2 received the same treatments in the reverse order. The effect of combined estradiol plus oral norethisterone acetate (NETA) 1 mg was also evaluated in the subset of women with intact uteri (n = 24). Crossover analysis showed that stroke volume and cardiac output were significantly higher (P < 0.05) and blood pressure was significantly lower (P < 0.05) with estradiol, irrespective of the order in which the treatments were administered. Although correlations between plasma estradiol levels during active treatment and hemodynamic changes were not significant, hemodynamic changes were significantly greater above 63 pg/ml than below this level (P < 0.05). Oral norethisterone acetate administration either during transdermal placebo or estradiol arms tended to modify systemic hemodynamics in the same direction than estradiol but the changes did not attained statistical significance. In summary compared with placebo, transdermal 17 beta-estradiol, replacement to postmenopausal women, increased cardiac output and decreased blood pressure. Although the average magnitude of changes was small, the results suggest that plasma estradiol levels could be a source of individual variability in the hemodynamic response. Oral NETA administration tended to enhance rather than reverse the estradiol-induced changes.
Assuntos
Estradiol/farmacologia , Terapia de Reposição de Estrogênios , Hemodinâmica/efeitos dos fármacos , Noretindrona/farmacologia , Pós-Menopausa/fisiologia , Congêneres da Progesterona/farmacologia , Administração Cutânea , Administração Oral , Pressão Sanguínea/efeitos dos fármacos , Pressão Sanguínea/fisiologia , Débito Cardíaco/efeitos dos fármacos , Estudos Cross-Over , Estradiol/administração & dosagem , Terapia de Reposição de Estrogênios/métodos , Feminino , Coração/efeitos dos fármacos , Coração/fisiologia , Frequência Cardíaca/efeitos dos fármacos , Frequência Cardíaca/fisiologia , Hemodinâmica/fisiologia , Humanos , Pessoa de Meia-Idade , Noretindrona/administração & dosagem , Pós-Menopausa/efeitos dos fármacos , Congêneres da Progesterona/administração & dosagem , Volume Sistólico/efeitos dos fármacosRESUMO
For some time the anti-ovulatory activity of certain estrogen/progestagen preparations was the main approach in fertility control. Up to date a drastic dosage reduction of both steroid hormones has been accomplished ameliorating the side effects on the one hand, and being active compounds as contraceptives, in the other. Currently, there are a wide variety of oral contraceptives available with a variety of estrogen doses combined with different progestagens. The estrogen content is a high as 80 micrograms and as low as 20 micrograms, moreover, such formulations are prescribed beginning the 1st or the 5th day of the menstrual cycle. By studying plasma and endometrial samples simultaneously obtained from chronic oral contraceptive users taking either 30 micrograms or 50 in such pills; a 17-beta-estradiol pattern was attained as that seen during follicular maturation in the ovulatory cycle only women under the lower dose of synthetic estrogen. However, in the endometrium such a cyclicity did not take place; in parallel circulating progesterone in both groups never reach levels greater than 5.0 ng/ml. Results offer to find a local critical period during the ovulatory menstrual cycle to achieve with much lower hormonal dosages a different approach in future methods of contraception.