Brazilian Postmenopausal Women Research Articles

Association Between Tooth Loss and Bone Mineral Density in Brazilian Postmenopausal Women

BackgroundTo evaluate oral health in postmenopausal women and verify whether there is a correlation between tooth loss according to index of decayed, missing, filled teeth (DMFT) and bone mineral density (BMD).MethodsA cross-sectional study was conducted with 100 women. The DMFT and its associations with lumbar and femoral BMD (T-score and g/cm2) were assessed. Analysis of covariance and multiple logistic regression were applied and the mean and standard deviation, absolute and relative frequencies (percentages) were obtained.ResultsThe analysis of covariance (ANCOVA) revealed significant association between the DMFT index and bone mass (T-score), compared to the young adult in L2-L4 (P = 0.0252) and in bone mass in L2-L4 (below average) in g/cm2 and in the DMFT index (P = 0.0332), and for women with bone mass below the average index DMFT was higher. Between L2-L4 below average (g/cm2) and extracted component (P = 0.0483) association was also significant because women with bone mass below the average had a greater extracted component.ConclusionsPostmenopausal women with poor oral health may present reduced bone mass. There was significant association between BMD and DMFT at the L2-L4 site. Women must be advised that their good oral health, amount and quality of bone mass should also be matters of concern.KeywordsBone mineral density; Post-menopausal; Osteoporosis; Tooth loss

Associations between healthy eating patterns and indicators of metabolic risk in postmenopausal women.

BackgroundSince human diets contain many components that may work synergistically to prevent or promote disease, assessing diet quality may be informative. The purpose of this study was to investigate the association between quality diet, by using Healthy Eating Index (HEI), and metabolic risk indicators in postmenopausal women.MethodsThis cross-sectional study included a total of 173 Brazilian women, aged 45-75 years, seeking healthcare at a public outpatient center. Food consumption assessed by 24 h-recall food inquiry was used to calculate HEI scores: >80 implied diet good, 80-51 diet "needed improvement", and <51 diet poor. Anthropometric data included: body mass index (BMI = weight/height2), waist-circumference (WC), body fat (%BF) and lean mass (%LM). Data on total cholesterol (TC), high density lipoprotein cholesterol (HDLC), low density lipoprotein cholesterol (LDLC), and triglycerides (TG) were also collected. Fisher's Exact test, and logistic regression method (to determine odds ratio, OR) were used in the statistical analysis.ResultsOverweight and obesity were observed in 75.7% of the participants. Excessive %BF (> 35%) was observed in 56.1%, while %LM was reduced (< 70%) in 78.1%. WC was elevated (≥88 cm) in 72.3%. Based on HEI values, diet quality was good in 3% (5/173), needed improvement in 48.5% (84/173), and was poor in 48.5% (84/173) of the cases. In this group, 75% of women had high intakes of lipids (> 35%), predominantly saturated and monounsaturated fat. On average, plasma TC, LDLC, and TG levels were higher than recommended in 57.2%, 79.2% and 45.1% of the women, respectively, while HDLC was low in 50.8%. There was association between HEI scores and the %BF that it was higher among women with HEI score < 80 (p = 0.021). There were not observed significant risk associations between HEI and lipid profile.ConclusionAmong the Brazilian postmenopausal women attending a public outpatient clinic, diet was considered to need improvement or to be of poor quality, attributed to high saturated fat ingestion, which probably caused a negative impact on metabolic risk indicators, namely body composition.

Assessment of risk factors for low bone mineral density in Brazilian postmenopausal women

Objective. To assess risk factors associated with low bone mineral density (BMD) in postmenopausal women.Methods. In this cross-sectional study, a total of 412 Brazilian postmenopausal women, aged 40–75 years, with BMD measured using central dual-energy X-ray absorptiometry, were included. The clinical risk factors assessed were: age, time since menopause, smoking, physical activity, use of hormone therapy (HT) or corticosteroids, personal fracture history, maternal history of fracture, and body mass index (BMI, weight/height2). Low BMD was considered when total spine and/or femoral neck T-score values were ≤ −2.0 standard deviations. Logistic regression was used to determine the odds ratio (OR) for low BMD in the presence of the influential variables analyzed.Results. Low BMD, which occurred in 36.6% (151/412) of the participants, was observed in 22.4% of women aged 40–49 years, in 34.2% of those aged 50–59 years, and in 60.5% of those > 60 years (p < 0.001). Similarly, low BMD was observed in 21.9% of women with menopause duration ≤ 5 years, in 39.5% with a duration of 6–10 years, and in 57.7% with menopause duration of > 10 years (p < 0.001). Seventy percent of women with BMI < 20 kg/m2 were osteopenic/osteoporotic (p < 0.001). The percentage of HT users was 37.4%; 27.7% took regular physical activity and 24.5% were smokers. The risk for low BMD detection increased significantly with age (OR 1.08; 95% confidence interval (CI) 1.02–1.14), time since menopause (OR 1.12; 95% CI 1.04–1.20), smoking (OR 3.43; 95% CI 1.67–6.96), fracture history (OR 2.05; 95% CI 1.11–3.78), and maternal history of fracture (OR 2.16; 95% CI 1.14–4.09). Physical activity, diet, corticotherapy and thyropathies did not influence risk. Contrarily, use of HT (OR 0.38; 95% CI 0.24–0.60) and high BMI (OR 0.89; 95% CI 0.84–0.96) reduced risk (p < 0.05).Conclusion. In postmenopausal women, age, time since menopause, smoking, and personal or maternal history of fracture were strong clinical indicators of risk for low BMD, whereas the use of hormone therapy and high BMI were shown to be protective factors.

Effect of abrupt discontinuation versus gradual dose reduction of postmenopausal hormone therapy on hot flushes

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 χ2 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.

Hormone therapy in Brazilian postmenopausal women with chronic hepatitis C: a pilot study

Objective To evaluate liver function and hemostatic parameters in postmenopausal women who have chronic infection with the hepatitis C virus and climacteric symptoms and are undergoing hormone therapy (HT) (standard dose of transdermal continuous combined hormone therapy).Design Fifty out of 336 postmenopausal patients with chronic infection with the hepatitis C virus were selected. The non-inclusion criteria were other chronic or systemic liver diseases, severe vascular diseases, autoimmune diseases or malignant tumors. The patients were randomized into two groups: the HT group with 25 patients to be given transdermal hormone therapy (50 μg estradiol plus 170 μg norethisterone/day) and the control group with the other 25 patients (no medication). Hepatic tests (alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, total alkaline phosphatase, albumin, serum bilirubin) and hemostatic parameters (prothrombin time, factor V, fibrinogen) were evaluated at baseline and at 1, 4, 7 and 9 months of treatment.Results No significant changes in parameters were found in the comparison between the treated group and the controls, except for a decrease in total alkaline phosphatase (p = 0.002), presumably due to changes in bone remodelling.Conclusions There were no changes in liver function after a 9-month treatment with transdermal estradiol plus norethisterone in symptomatic postmenopausal patients with hepatitis C.

Application of Osteorisk to postmenopausal patients with osteoporosis.

Identification of women at risk of bone fracture is becoming less dependent on evaluating bone mineral density through placing greater value on clinical risk factors. The aim of this study was to evaluate the sensitivity of the Osteorisk clinical tool for identifying Brazilian postmenopausal women with osteoporosis, compared with bone densitometry. Cross-sectional observational study at Faculdade de Medicina do ABC. Information on 812 postmenopausal osteoporotic women was retrospectively evaluated from medical records. The women were divided into the age groups 50-59, 60-69, 70-79 and over 80 years. The results from the Osteorisk clinical tool, which uses only age and weight, were compared with bone densitometry T-scores. There were significant correlations between the results from the Osteorisk clinical tool and from bone densitometry, in relation to the lumbar spine (P = 0.027) and hip (P < 0.001), thus showing a non-arbitrary relationship. The overall sensitivity of Osteorisk for identifying women with "high risk of osteoporosis" was 86.5%, and it was higher for hip osteoporosis alone (97.2%) than for lumbar spine osteoporosis (85.8%). The sensitivity was better among older women. Osteorisk seems to present good sensitivity for identifying postmenopausal women at risk of osteoporosis. It should be used when bone densitometry is not easily available or as a means of selecting individuals for referral for bone densitometry.

Hormone therapy in Brazilian postmenopausal women with chronic hepatitis C: a pilot study

Hormone therapy in Brazilian postmenopausal women with chronic hepatitis C: a pilot study

Metabolic syndrome and its associated risk factors in Brazilian postmenopausal women

Objective To evaluate the prevalence of metabolic syndrome (MetS) and its associated risk factors in Brazilian postmenopausal women.Methods In this cross-sectional study, a total of 368 postmenopausal women, aged 40–– 75 years, seeking health care at a public outpatient center in Southeastern Brazil, were included. According to the US National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines, MetS was diagnosed in subjects with three or more of the following: waist circumference ≥88 cm, blood pressure ≥130/85 mmHg, triglycerides ≥150 mg/dl, high density lipoprotein cholesterol <50 mg/dl and glucose ≥110 mg/dl. Data on past medical history, tobacco use, anthropometric indicators, and values of C-reactive protein (CRP) were collected. Multivariate analysis, using a logistic regression model (odds ratio, OR) was used to evaluate the influence of various simultaneous MetS risk factors.Results The prevalence of having at least three, four and five MetS diagnostic criteria were met in 39.6%, 16.8% and 3.8% of the cases, respectively. The most prevalent risk factor was abdominal obesity, affecting 62.5% of women. The risk of MetS increased with a personal history of diabetes (OR 5.95, 95% confidence interval (CI) 2.82–12.54), hypertension (OR 4.52, 95% CI 2.89–7.08), cardiovascular disease (OR 2.16, 95% CI 1.18–3.94) and high CRP (>1 mg/dl) (OR 3.35, 95% CI 1.65–6.79). Plasma CRP levels increased with the number of MetS components present. Age, time since menopause and smoking had no influence, while hormone therapy reduced MetS risk (OR 0.64, 95% CI 0.42–0.97).Conclusion Metabolic syndrome was highly prevalent among Brazilian postmenopausal women seeking gynecologic health care. Abdominal obesity, diabetes, hypertension and high CRP were strong MetS predictors and hormone therapy appeared to play a protective role for this condition.

Breast arterial calcification is a predictive factor of cardiovascular disease in Brazilian postmenopausal women

Objective The objectives of this study were to evaluate the association between cardiovascular disease (CVD) and breast arterial calcification (BAC), as well as the prevalence rates of these conditions in Brazilian postmenopausal women.Methods A cross-sectional study was performed in 307 women over 40 years of age who were receiving care at the gynecology clinic of the Center for Women's Integrated Healthcare (CAISM), ABC School of Medicine. All these women had been amenorrheic for at least 12 months and had undergone mammography in the preceding 12 months. Cardiovascular disease and its subtypes were evaluated, as well as its association with BAC. Means and standard deviations, absolute frequencies and percentages were calculated, and univariate analysis and multiple logistic regression were performed.Results The mean age of the patients was 55.2 ± 6.8 years; age at menopause was 48.5 ± 4 years. Time since menopause was 80.2 ± 75.4 months; 96.1% of the patients were non-smokers and 46.3% were using hormone therapy. Of the patients, 33.6% had systemic arterial hypertension, 4.9% had diabetes mellitus and 5.2% had hypercholesterolemia. The mean body mass index was 27.3 ± 4.3 kg/m2. CVD was found in 6.8% and BAC in 8.5% of the women. Significantly more women with BAC had CVD compared to the women who did not have this condition (23.1% vs. 5.3%, p = 0.0006). BAC was associated with an odds ratio of 8.13 (95% confidence interval 2.68–24.64) for predicting CVD.Conclusions In postmenopausal women, breast arterial calcification may represent a higher likelihood of cardiovascular disease.

Lack of effects of isoflavones on the lipid profile of Brazilian postmenopausal women

Objective To evaluate the effects of soy isoflavone supplementation on profile lipid and endogenous hormone levels. Methods In this double-blind, placebo-controlled study, 47 postmenopausal women 47–66 y of age received 40 mg of isoflavone ( n = 25) or 40 mg of casein placebo ( n = 22). Cardiovascular risk factors were assessed by evaluating lipid profile at baseline and after 6 mo of treatment. To examine the effects of this regime on endogenous hormone levels, follicle-stimulating hormone and β-estradiol were measured. Urinary isoflavone concentrations (genistein and daidzein) were measured as markers of both compliance and absorption using high performance liquid chromatography. Baseline characteristics were compared by the unpaired Student's t-test. Within-group changes were determined by paired Student's t-test and comparison between the isoflavone and casein placebo groups were determined by analysis of variance. Results Lipid levels (low-density lipoprotein and total cholesterol) similarly decreased in both groups. High-density lipoprotein increased significantly in both groups and cannot thus be attributable to treatment; the reason for such variation is unknown and can be attributed to chance or to bias (even that of a real placebo effect in both groups or perhaps in spontaneous changes in exercise and dietary habits of patients after their inclusion). Furthermore, in both groups very low-density lipoprotein and triacylglycerol levels increased in a non-significant manner. Conclusion The results of the present study do not support any biologically significant estrogenic effects of isoflavone on the parameters assessed. Further research will be necessary to definitively assess the safety and efficacy of isoflavone.

Relationship Between Nutrient Intake and Vitamin D Status in Osteoporotic Women

Vitamin D is essential for maintaining calcium homeostasis and optimizing bone health. Its inadequacy is related to many factors including dietary intake. The aim of the present study was to evaluate serum 25(OH)D and its relationship with nutrient intakes in postmenopausal Brazilian women with osteoporosis. This cross-sectional study comprised 45 free-living and assisted elderly at São Paulo Hospital. Three-day dietary records were used to assess dietary intakes. Bone mineral density was measured with a dual-energy X-ray absorptiometer (DXA). Blood and urine sample were collected for analysis of biochemical markers of bone and mineral metabolism. Insufficiency of vitamin D was observed in 24.4% of the women and optimal levels (> or = 50 nmol/L) were observed in 75.6%. Parathyroid hormone was above the reference range in 51% of the participants. The mean calcium (724 mg/day) and vitamin D (4.2 microg/day) intakes were lower than the value proposed by The Food and Nutrition Board and sodium intake was more than two-fold above the recommendation. Higher levels of serum 25(OH)D were inversely associated with sodium intake. Dietary strategies to improve serum vitamin D must focus on increasing vitamin D intake and should take a reduction of sodium intake into consideration.

Lack of Association Between Vitamin D Receptor Genotypes and Haplotypes With Fat-Free Mass in Postmenopausal Brazilian Women

The relationship between vitamin D receptor (VDR) ApaI, CDX2, BsmI, FokI, and TaqI polymorphisms and fat-free mass (FFM) were examined in 191 postmenopausal Brazilian women (mean age 67.87 +/- 5.22 years). Participants underwent FFM measurements by dual-energy x-ray absorptiometry (DEXA). Whole-blood-extracted genomic DNA was genotyped to the aforementioned polymorphisms and to ancestry-informative markers through minisequencing, using the SNaPshot Multiplex System. Association between VDR polymorphisms and FFM variables was assessed by analysis of covariance. Haplotypes were estimated, and regression-based, haplotype-specific association tests were carried out with the studied phenotypes. No departure from Hardy-Weinberg equilibrium was detected for any polymorphism. None of the investigated VDR allelic variations, individually or analyzed as haplotypes, was associated with FFM phenotypes. The inclusion of individual African genomic ancestry was used as an attempt to correct for population stratification. Further studies in larger sample population are required to confirm these findings.

Physical Activity, Cdx-2 Genotype, and BMD

The present study investigated the interaction between Cdx-2 polymorphism and physical activity level over bone mineral density (BMD) variation in Brazilian postmenopausal women. One hundred and ninety women volunteered to participate in the study (66.6 +/- 5.3 years, 64.58 +/- 11.74 kg and 151.94 +/- 6.36 cm). Physical activity level (PAL) was assessed using the international physical activity questionnaire (IPAQ). Lumbar spine (L2 - L4), femoral neck, great trochanter and Wards' triangle bone mineral density (BMD) were measured by dual-energy X-ray absorptiometry (DXA). The Cdx-2 polymorphism was genotyped by minisequencing, using the SNaPshottrade mark Multiplex System (Applied Biosystems, Foster City, CA, USA). Overall, no significant association was found between Cdx-2 polymorphism and adjusted BMD at any site. However, the results revealed a significant interaction between PAL and Cdx-2 genotype on adjusted femoral neck and Wards' triangle BMD. Active women carrying the Cdx-G/G genotype showed higher adjusted femoral neck and Wards' triangle BMD than inactive women carrying the same genotype, thus suggesting a larger chronic response to physical activity. These results suggest that, in postmenopausal women, the Cdx-2 polymorphism does not influence BMD by itself; however, it seems to affect the BMD response to physical activity since only the Cdx-G/G genotype carriers presented significant differences between active and inactive.

Hormone replacement therapy and hemostasis: Effects in Brazilian postmenopausal women

Objective To evaluate the impact that administration of transdermal estradiol gel combined with medroxyprogesterone acetate (MPA) has on hemostasis. Methods In this open prospective longitudinal study, thirty postmenopausal women received transdermal estradiol gel (1 mg/day) continuously combined with oral MPA (5 mg/day) for 12 days/month. The following parameters were determined: prothrombin time (PT), activated partial thromboplastin time (aPTT), factors VII, X, and XII activity, fibrinogen levels, thrombin-antithrombin complex levels, protein C and S antigen, antithrombin activity, plasminogen activator inhibitor type 1 (PAI-1) antigen, tissue-type plasminogen activator (t-PA) antigen, plasminogen activity and fibrin degradation products (FbDP) antigen. They were evaluated before and after 6 months of treatment. Results There was a significant decrease in factor VII activity ( P = 0.001), factor X activity ( P = 0.016), protein C antigen ( P = 0.022), antithrombin activity ( P = 0.025), plasminogen activity ( P = 0.023), t-PA antigen ( P = 0.043) and FbDP antigen ( P = 0.048) compared with baseline values. Conclusion The results suggest that the treatment with transdermal estradiol gel combined with MPA avoids any major activation of coagulation and does not produce any overall effect on fibrinolysis. Therefore, this treatment might provide interesting effects on hemostasis in postmenopausal Brazilian women.

To What Extent Is Bone Mineral Density Determined By Body Composition In Brazilian Postmenopausal Women?

2051 Previous study of the relative importance of fat mass (FM) and Fat Free Mass (FFM) as a determinant of bone mineral density (BMD) have yielded discordant results. Additionally, Aloia et al. (1995) reported that bone mass may be partially influenced by race. PURPOSE: The aim of this study was to determine to what extent bone mineral density (BMD) is determined by body mass (BM), FM, and FFM in healthy Brazilian postmenopausal women. METHODS: Total body composition and regional bone mass were measured in 97 sedentary, healthy postmenopausal women recruited from the general community. The mean age was 66.41 ± 4.82 years, range 60–79. Total body composition (fat and lean tissue) and regional bone density in the lumbar spine and femur were measured by dual energy X-ray absorptiometry (DXA) on a Lunar DPX-IQ. The participants were screened for medical conditions that may alter BMD, and were excluded from the study if they had been on hormone-replacement therapy (HRT). Contraindications also included: cigarette smoking and alcohol abuse. The relationship of BM, FM and FFM with BMD were first generated separately using linear regression (bivariate). Multiple linear regression then was used to determine the relative contribution of BM, FM and FFM to the variance in BMD. RESULTS: Total BM was more strongly correlated with femur and lumbar spine BMD (r = 0.54 and 0.37, respectively) than FM (r = 0.30 and 0.19) and FFM (r = 0.44 and 0.26). CONCLUSION: Both fat and lean tissue mass are related to femur bone mass in postmenopausal women, however the relationship being strongest for body weight. FM shows weaker correlations for both femur and lumbar BMD. In view of the direction and magnitude of changes in body composition and bone mineral after the menopause, body weight and muscularity are more likely to be determinants of peak bone mass of postmenopausal Brazilian women.

To What Extent Is Bone Mineral Density Determined By Body Composition In Brazilian Postmenopausal Women?

2051 Previous study of the relative importance of fat mass (FM) and Fat Free Mass (FFM) as a determinant of bone mineral density (BMD) have yielded discordant results. Additionally, Aloia et al. (1995) reported that bone mass may be partially influenced by race. PURPOSE: The aim of this study was to determine to what extent bone mineral density (BMD) is determined by body mass (BM), FM, and FFM in healthy Brazilian postmenopausal women. METHODS: Total body composition and regional bone mass were measured in 97 sedentary, healthy postmenopausal women recruited from the general community. The mean age was 66.41 ± 4.82 years, range 60–79. Total body composition (fat and lean tissue) and regional bone density in the lumbar spine and femur were measured by dual energy X-ray absorptiometry (DXA) on a Lunar DPX-IQ. The participants were screened for medical conditions that may alter BMD, and were excluded from the study if they had been on hormone-replacement therapy (HRT). Contraindications also included: cigarette smoking and alcohol abuse. The relationship of BM, FM and FFM with BMD were first generated separately using linear regression (bivariate). Multiple linear regression then was used to determine the relative contribution of BM, FM and FFM to the variance in BMD. RESULTS: Total BM was more strongly correlated with femur and lumbar spine BMD (r = 0.54 and 0.37, respectively) than FM (r = 0.30 and 0.19) and FFM (r = 0.44 and 0.26). CONCLUSION: Both fat and lean tissue mass are related to femur bone mass in postmenopausal women, however the relationship being strongest for body weight. FM shows weaker correlations for both femur and lumbar BMD. In view of the direction and magnitude of changes in body composition and bone mineral after the menopause, body weight and muscularity are more likely to be determinants of peak bone mass of postmenopausal Brazilian women.

Apolipoprotein E isoforms are apparently not related to lipid profile modification in brazilian postmenopausal women

Apolipoprotein E isoforms are apparently not related to lipid profile modification in brazilian postmenopausal women

Evaluation of skin tolerability in patients on a 7-day regimen of a new matrix transdermal estradiol delivery system: an open-label study

The incidence and severity of local skin reactions, as well as the impact on the local bacteriologic profile, in a 7-day regimen of a matrix transdermal estradiol delivery system compared with placebo (a piece of adhesive tape for sensitive skin of approximately the same shape and area) were assessed in healthy postmenopausal Brazilian women in an open-label study. The matrix estradiol and placebo patches were applied to different sites of the abdominal area, worn for 7 consecutive days, and then replaced according to an established rotation schedule, until 5 weeks of treatment were completed. The rotation schedule was adopted to provide an assessment of skin reaction as related to (1) interval between two consecutive placements at the same application site; (2) number of repetitions; and (3) abdominal region (upper, middle, and lower). A skin reaction score was obtained at each site before the application of each patch, 30 minutes after patch removal, and 7 days after patch removal. Skin swabs were obtained for bacteriologic cultures immediately before patch application and immediately after patch removal. Twenty-seven women were enrolled and completed the study; 270 skin observations were made with the estradiol patch and 162 with placebo. Skin reactions 30 minutes after patch removal included erythema (23.7%), erythema with induration (4.1%), and erythema with induration and vesicles (1.1%). Seven days after patch removal, skin reactions had decreased to erythema (2.2%) and erythema with induration (0.4%); no erythema with induration and vesicles was seen. This reduction in incidence and severity was statistically significant. Thirty minutes after placebo removal, 2.5% of skin observations detected erythema; no erythema was observed 7 days later. No other severe reactions were observed, and no clinically significant alteration in skin flora was detected. The results of this study indicate an acceptable level of local skin responses to this 7-day estradiol patch application. In addition, 96.3% of patients rated the estradiol patch as good or very good in its acceptability.