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Biomedical subjects

N R de Melo

Publications and source records attributed to N R de Melo.

9 recordsLinked to original sources

Hormone therapy following the Women's Health Initiative (WHI) study: perception of gynecologists in Brazil.

AIM: The objective of the present study was to evaluate the effects of the Women's Health Initiative (WHI) study on gynecologists in Brazil, with particular emphasis on knowledge, interpretation of the study and attitude regarding hormone therapy (HT). METHODS: A total of 806 gynecologists were evaluated through questionnaires. For the evaluation, questions regarding his/her degree of knowledge and interpretation of the WHI study, number of prescriptions written for HT and opinion regarding the ideal form of HT following the WHI study were analyzed. RESULTS: Physicians were found to have a good knowledge of the study (97.6%). The most common interpretation of the results of the WHI study referred to the single HT regimen used in the trial in patients with specific characteristics, this being the response of 66.3% of physicians. There was a reduction of 21.7% in the intention to prescribe HT, with 32.5% of gynecologists reporting changing to a different therapeutic regimen. After the WHI study, the gynecologists showed a preference for low doses of estrogens and progestogens. CONCLUSIONS: The WHI study had a relevant impact on the attitude of doctors in Brazil.

Brazil↗

Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial.

BACKGROUND: This trial was conducted to compare cycle control with vaginal ring a combined contraceptive vaginal ring, and a combined oral contraceptive (COC) delivering 30 mug ethinylestradiol (EE) and 150 mug levonorgestrel. METHODS: This open-label, randomized, multi-centre, Phase III study involved adult women from 11 countries. Subjects were treated with either vaginal ring or a COC for 13 cycles (12 months). RESULTS: A total of 1030 subjects (vaginal ring, n=512; COC, n=518) comprised the intention-to-treat (ITT) population. The percentage of women in the ITT population who completed the trial was 70.9% for vaginal ring and 71.2% for the COC group. The incidence of breakthrough bleeding and spotting over cycles 2-13, the primary efficacy parameter, was lower with vaginal ring (range 2.0-6.4%) than the COC (range 3.5-12.6%), and for cycles 2 and 9 the lower incidence with vaginal ring was confirmed as statistically significant (P=0.003 and P=0.002 respectively). The incidence of intended bleeding was significantly higher over all cycles with vaginal ring (58.8-72.8%) than with the COC (43.4-57.9%). CONCLUSIONS: Cycle control with vaginal ring was excellent and superior to that of a COC containing 30 mug EE.

Adult↗

A prospective open-label study to evaluate the effects of the oral contraceptive Harmonet (gestodene75/EE20) on body fat.

This open-label study evaluated the effects on body fat of the use of a low-dose oral contraceptive (gestodene75/EE20) in a group of 61 women (OC-U group) as compared to a nonuser group (OC-N group) of 51 women who did not receive an oral contraceptive. Weight, body mass index (BMI), waist-over-hip ratio and body composition data, obtained by bioelectrical impedance [percentages of body fat (%FAT), water (%TBW) and lean mass (%FFM)], were assessed before and after six treatment cycles. Baseline OC-U group weight, BMI, %FAT, %TBW and %FFM did not differ from the OC-N group, either at baseline or at the end of the study, and did not significantly change within each group during the study. Also, there was no modification of fat distribution in either group. Among women in the OC-U group, there was a slight increase in total cholesterol levels and a trend towards higher triglycerides levels. No changes were detected in blood pressure. In conclusion, this low-dose oral contraceptive did not affect weight or body composition. Thus, our data suggest that gestodene75/EE20 represents an appropriate OC choice and may enhance compliance of women who mistakenly believe that the use of oral contraceptives always leads to weight gain.

Adolescent↗

Latin american experience with two low-dose oral contraceptives containing 30 microg ethinylestradiol/75 microg gestodene and 20 microg ethinylestradiol/150 microg desogestrel.

The objective of this study was to compare cycle control, efficacy and tolerance of an oral contraceptive containing 20 microg ethinylestradiol and 150 microg desogestrel with a preparation containing 30 microg ethinylestradiol combined with 75 microg gestodene. This study involved 342 women and 4104 cycles use in Argentina, Brazil, Chile, and Mexico. Contraceptive efficacy was good with both formulations. Two pregnancies occurred in the desogestrel group but were not due to method failure. With respect to cycle control, the incidence of intermenstrual bleeding was higher during the first 3 cycles in the desogestrel group; it was significant (p <0.01) during the first 3 days of the cycle for a normal or heavy bleeding only in the Mexican group. Amenorrhea was not reported for any group, but the incidence of dysmenorrhea was significantly higher (p <0.01) in the Brazilian desogestrel group (13.8%) and was significantly lower (p <0.01) in the Mexican gestodene group (8.5%). Adverse events were similar in all the countries with headache, breast tension, and nausea, the most frequently reported symptoms. The range of mean increase in body weight varied from 0.2 kg in the Argentine group to 2.6 kg in the Chilean group (95% confidence limit, +/- 2.51) in the gestodene group, and 0.2 kg in the Argentine group to 2.5 kg in Brazilian group (95% confidence limit, +/- 2.36) in the desogestrel group. Fifteen women discontinued because of headache, but there were no significant differences between the groups regarding discontinuation for this and other medical or non-medical reasons. Both oral contraceptive preparations are reliable and well tolerated, and both have favorable effects on control cycle.

Adolescent↗

Efficacy and acceptability of two monophasic oral contraceptives containing ethinylestradiol and either desogestrel or gestodene.

OBJECTIVE: To assess the contraceptive efficacy, cycle control and acceptability of two monophasic oral contraceptives containing either 30 micrograms ethinylestradiol plus 150 micrograms desogestrel or 30 micrograms ethinylestradiol plus 75 micrograms gestodene. METHODS: In a randomized, open-label, six-cycle, group-comparative, multicenter study performed in Brazil, pregnancies, cycle-control parameters, incidence of side-effects and the presence and severity of acne vulgaris were assessed, and blood pressure and body weight were measured at pretreatment and after one, three and six cycles of oral contraceptive use. RESULTS: Of the 595 women enrolled, 274 (86.7%) in the desogestrel/ethinylestradiol group and 227 (81.4%) in the gestodene/ethinylestradiol group completed the six cycles, providing data for 1753 and 1487 treatment cycles, respectively. Two pregnancies occurred, one of which (in the desogestrel/ethinylestradiol group) was attributed to user failure, whilst the other (in the gestodene/ethinylestradiol group) was thought to result from method failure. Cycle control was observed to be excellent; the incidences of irregular bleeding and minor side-effects were low in both groups and decreased after an initial increase in the first cycle. Pre-existing acne improved in both groups, whereas blood pressure and body weight remained essentially unchanged. CONCLUSIONS: Both desogestrel/ethinylestradiol and gestodene/ethinylestradiol provide effective oral contraception with comparable cycle control and acceptability.

Acne Vulgaris↗

Mental health among perimenopausal women attending a menopause clinic: possible association with premenstrual syndrome?

BACKGROUND: Psychiatric symptoms are frequent in the perimenopause. They are similar to symptoms observed at different stages of a woman's life cycle, suggesting that there may be an association between mental disturbances of the perimenopause and those observed during premenstrual and postnatal periods. METHODS: This study aimed to determine the reliability of using a modified version of the Steiner premenstrual tension self-rating scale (PMTS) questionnaire for assessing retrospectively the presence of premenstrual complaints and to evaluate the association between previous premenstrual complaints and psychiatric symptoms at the time of the menopause. Forty-one perimenopausal women were selected to establish the reliability of the questionnaire to assess premenstrual symptoms retrospectively (4-8-week interval between measures); agreement between measurements was assessed using the kappa statistic. Ninety-six women were later recruited from a gynecological menopause outpatient clinic to study the association between premenstrual complaints and the presence of psychiatric symptoms at the time of the menopause (as measured by another self-reporting questionnaire, the SRQ-20); SRQ-20 total scores greater than 7 were considered to be indicative of psychiatric morbidity. RESULTS: All 36 PMTS items showed moderate to very good test-retest reliability (0.44 < kappa < 1.0). There was a significant correlation between total PMTS and SRQ-20 scores (Spearman correlation coefficient 0.75, p < 0.001), correlation coefficient and SRQ-20 total scores greater than 7 were found in 47.9% of patients. CONCLUSIONS: Premenstrual symptoms can be reliably measured in perimenopausal women. Women who report having experienced premenstrual dysphoria are more likely to present with psychiatric symptoms at the time of the menopause.

Adult↗

Oral estradiol-17 beta raises the level of plasma high-density lipoprotein in menopausal women by slowing down its clearance rate.

Plasma lipoprotein composition, plasma kinetics of autologous [125I]HDL and the metabolism of iv administered radioactively labelled artificial chylomicrons were studied in postmenopausal women during a control period and after 4 months of oral estradiol-17 beta treatment (1 mg/m2 body surface per day). Drug treatment significantly raised plasma HDL-cholesterol levels (19%) in the fasting state and total apolipoprotein A-I (16%), but did not interfere with triglyceride, VLDL, LDL or apolipoprotein-B values. As compared with the control period, estradiol-17 beta administration significantly slowed down plasma [125I]HDL clearance by about 82% and reduced the delipidation index of the injected artificial chylomicrons by 47% as a consequence of impaired plasma lipolytic activity.

Administration, Oral↗