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Biomedical subjects

E M Coutinho

Publications and source records attributed to E M Coutinho.

At least 19 recordsLinked to original sources
PubMed1997

Multicenter, double-blind, comparative clinical study on the efficacy and acceptability of a monthly injectable contraceptive combination of 150 mg dihydroxyprogesterone acetophenide and 10 mg estradiol enanthate compared to a monthly injectable contraceptive combination of 90 mg dihydroxyprogesterone acetophenide and 6 mg estradiol enanthate.

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.

Adolescent↗
PubMed1997

Polypectomy and endometrial resection in postmenopausal patients.

STUDY OBJECTIVE: To evaluate the therapeutic efficacy of polypectomy associated with endometrial resection for the treatment of polyps in postmenopausal women. DESIGN: Prospective study (Canadian Task Force classification II-2). SETTING: Private urban hospital with facilities for endoscopic surgery. PATIENTS: Sixty-six women with endometrial polyps. INTERVENTIONS: Sixty-four of the 66 patients underwent polypectomy followed by endometrial resection. One patient had hysterectomy because endometrial biopsy showed serous papillary carcinoma. MEASUREMENTS AND MAIN RESULTS: No major complications were associated with the procedure. Histopathology showed hyperplasia in most polyps. One patient had a papillary uterine carcinoma in the polyp that was not detected by preoperative endometrial biopsy. The women were followed with transvaginal sonography for 1 year after surgery. CONCLUSION: Polypectomy followed by endometrial resection is a very low-risk procedure for postmenopausal patients. There was no recurrence after the first year in women who completed follow-up.

Aged↗
PubMed1997

Administration of medroxyprogesterone acetate after endomyometrial resection.

STUDY OBJECTIVE: To assess the efficacy of endometrial resection for treatment of menorrhagia in women to whom no preoperative agent was given to prepare the endometrium. DESIGN: Retrospective analysis of patients' records for all endometrial resections in which medroxyprogesterone acetate was used postoperatively. SETTING: Hospital day surgery unit. PATIENTS: Seventy patients with menorrhagia. INTERVENTIONS: The women underwent transvaginal sonography, followed by hysteroscopy and endometrial biopsy. The endometrium was removed using the 27F resectoscope followed by coagulation with the rollerball. Medroxy-progesterone acetate was prescribed for 2 months after surgery. MEASUREMENTS AND MAIN RESULTS: All women achieved a reduction in menstrual flow and 50% reported amenorrhea after endometrial resection. In only two was hysterectomy necessary due to recurrence of menorrhagia. CONCLUSION: Preoperative endometrial preparation was unnecessary when endometrial resection was carried out for treatment of menorrhagia. However, the patients received medroxyprogesterone acetate postoperatively.

Adult↗
PubMed1996

Multicenter clinical trial on the efficacy and acceptability of a single contraceptive implant of nomegestrol acetate, Uniplant.

Uniplant, a single Silastic implant containing nomegestrol acetate, provides contraceptive efficacy for one year. Uniplant use for one year was studied in 1,803 healthy women of reproductive age, enrolled from 10 centers in 9 countries, after informed consent. Implants were placed subdermally either in the upper arm or in the gluteal region. Two-hundred-seventy-six subjects discontinued prior to completing one year of study. Cumulative discontinuation rate at 12 months was 15.72%. Medical reasons for discontinuation were principally menstrual-related. Fifteen pregnancies occurred during the one year study period, resulting in a 12-month net cumulative pregnancy rate of 0.94%. Approximately 56% of subjects using Uniplant had bleeding patterns similar to normal menstruation. Results from this study confirm that Uniplant is an efficient, well tolerated, 12-month contraceptive implant, with the advantage of easier insertion and removal of the single implant compared to other multiple implant methods.

Adult↗
PubMed1996

Evaluation of the endometrial cavity during menopause.

OBJECTIVE: To compare transvaginal sonography (TVS), hysteroscopy and suction curettage in the evaluation of uterine bleeding during the menopause. METHODS: Forty-seven patients who presented with either postmenopausal bleeding (31 cases) or sonographic endometrial abnormalities at menopause (16 cases) were evaluated using TVS, hysteroscopy, and curettage with a Karman curette. RESULTS: When endometrial thickness measured by TVS was < 4 mm, there was no endometrial pathology. However TVS could not differentiate accurately between hyperplasia, polyps or endometrial carcinoma. In these cases, endometrial thickness was invariably greater than 5 mm. CONCLUSIONS: Hysteroscopy proved superior to curettage in the diagnosis of endometrial polyps.

Adult↗
PubMed1996

Results of a user satisfaction study carried out in women using Uniplant contraceptive implant.

A study of the acceptability of Uniplant, a 12-month single implant of nomegestrol acetate, included 819 women from Africa, Latin America, and China, participating in a clinical trial of Uniplant. A standard, pre-coded questionnaire was specially designed for this purpose and applied at the moment of removal of implant, either at the end of 12 months of use or at the time of discontinuation for whatever reason. The level of satisfaction proved high when users' comparison with their previous contraceptive method, users' recommendation of Uniplant to others, users' intention to use the method in the future, and service satisfaction were taken into consideration. Uniplant was considered easy to use, safe (low risk of pregnancy), and also to cause fewer side effects than other methods. When asked about the least liked feature of Uniplant, almost half the respondents said that there was nothing that they disliked and about one-third mentioned the changes in their menstrual pattern. However, according to the clinical trial, over half of the Uniplant users have bleeding patterns similar to untreated cycles. The majority of respondents did not feel any discomfort during the procedure of insertion and removal of the implant. About 70% of patients in the study stated that they required contraception for more than one year and most of these women said that they did not mind having to change the implant every year.

Adult↗
PubMed1996

Hysteroscopy and transvaginal sonography in menopausal women receiving hormone replacement therapy.

STUDY OBJECTIVE: To evaluate the endometrial cavity of menopausal women with irregular bleeding while receiving hormone replacement therapy. DESIGN: Comparative evaluation of hysteroscopic and biopsy findings. SETTING: A center for reproductive studies. PATIENTS: Forty-one patients receiving different regimens of hormone replacement therapy. INTERVENTIONS: Hysteroscopy, endometrial biopsy, and transvaginal sonography were performed in all 41 women. In 10 patients, endometrial polyps were removed with the resectoscope. MEASUREMENTS AND MAIN RESULTS: Irregular bleeding during hormone replacement therapy was associated with atrophic endometrium whenever transvaginal sonography showed endometrial thickness to be less than 4 mm. In patients who developed increased endometrial thickness after hormone replacement therapy, hysteroscopy revealed the presence of endometrial polyps in the uterine cavity. Histopathologic examination of excised polyps revealed cystic or adenomatous hyperplasia confined to these lesions. CONCLUSIONS: Endometrial polyps can appear in menopausal women receiving hormone replacement therapy despite the presence of progestins to oppose the action of estrogens.

Atrophy↗
PubMed1995

Effects of an implant of nomegestrol acetate, a 19-nor-progesterone derivative, on thyroid function.

This study was undertaken to assess tri-iodothyronine (T3), thyroxine (T4), thyroid stimulating hormone (TSH), T3 uptake, free T3 and free T4 in nomegestrol acetate implant (Uniplant) users. A total of eighteen volunteers of reproductive age who wanted to avoid conception were enrolled in the study. All subjects were investigated before starting treatment. Blood samples for hormonal analysis were taken prior to insertion of the implant. Thereafter, blood samples were drawn at 3, 6, 12, 18 and 24 months of Uniplant use. All subjects had used non-hormonal contraceptives for at least 6 months prior to insertion of the implant. The results observed in this study showed that there was no significant difference in tri-iodothyronine (T3), thyroxine (T4) and thyroid stimulating hormone (TSH) during two years of Uniplant use. No significant difference was found in free T3 levels during two years of Uniplant use. A significant decrease was observed in T3 uptake (p < 0.05) in month 24 and in free T4 (p < 0.05) in month 3 of Uniplant use. All changes observed in this study were inconsistent and all levels were within the normal range.

Adult↗
PubMed1995

Comparative study on intermittent versus continuous use of a contraceptive pill administered by vaginal route.

A multicenter, international, randomized, comparative trial was conducted to assess the acceptability, efficacy and safety of two different schedules of a contraceptive pill, containing 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol, administered by the vaginal route. One schedule of daily administration for 21 days with a seven-day interruption to allow withdrawal bleeding was compared to daily administration without interruption for bleeding. A total of 900 women were recruited in three countries, Brazil, Egypt and China; 7,090 women-months of vaginal pill use were recorded (3,364 using the pills intermittently and 3,726 continuously). Four undesired pregnancies occurred, one in Egypt and three in China, all four in women using the pills intermittently. There was a statistically significant difference (p = 0.486) in pregnancy rate between the two groups. There were no other significant differences in discontinuation rates despite marked differences in bleeding patterns, amenorrhea predominating in the continuous use group. Hemoglobin levels increased significantly in the two groups but hematocrit was significantly higher in the continuous use group.

Administration, Intravaginal↗
PubMed1994

Contraceptive implants.

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.

Adolescent↗
PubMed1993

One year contraception with a single subdermal implant containing nomegestrol acetate (Uniplant).

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.

Adult↗
PubMed1993

Comparative study on the efficacy and acceptability of two contraceptive pills administered by the vaginal route: an international multicenter clinical trial.

The efficacy and acceptability of two widely used oral contraceptive tablets, one containing 250 mg levonorgestrel and 50 micrograms ethinyl estradiol and the other containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol, administered by the vaginal route were compared in 1055 women studied over 12,630 woman-months of vaginal contraceptive pill use. This multicenter clinical trial was performed in nine countries of the developing world by the "South to South Cooperation in Reproductive Health," an organization founded by scientists from the Third World working in the area of reproductive health, and the study was developed and coordinated by one of these centers. The findings of this study confirm the efficacy of both these tablets when administered by the vaginal route. Involuntary pregnancy rates at 1 year of 2.78 for subjects in the levonorgestrel group and 4.54 for subjects the desogestrel group showed no statistically significant difference between the two groups. However, total discontinuation rates of 47.01 for subjects in the levonorgestrel group and 56.33 for subjects in the desogestrel group showed a statistically significant difference between the two groups, and discontinuation rates attributable to prolonged bleeding of 0.6 for subjects in the levonorgestrel group and 3.2 for subjects in the desogestrel group were also significantly higher in the group of subjects using the desogestrel vaginal contraceptive pill. Blood pressure remained at admission values throughout treatment. A statistically significant weight increase from admission values occurred in both groups of subjects.

Administration, Intravaginal↗
PubMed1993

Comparative study on the efficacy, acceptability, and side effects of a contraceptive pill administered by the oral and the vaginal route: an international multicenter clinical trial.

The objective of this multicenter randomized clinical trial was to compare the efficacy, acceptability, and occurrence of side effects associated with the oral versus vaginal route of administration of contraceptive pills. Eight hundred nineteen healthy, parous women of reproductive age were recruited at family planning clinics and research centers, members of the South to South Cooperation in Reproductive Health, in seven countries of the developing world. These women were randomly assigned to use either oral or vaginal administration of the same contraceptive pill, which contained 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol. No statistically significant differences were found in discontinuation rates between the two groups after 1 year. Involuntary pregnancy rates after 1 year were not statistically significantly different between the two groups. The vaginal route of administration appears to be as acceptable and efficacious as the oral route.

Administration, Intravaginal↗
PubMed1992

Nutrition and acute schistosomiasis.

In northeast Brazil, nutritional deficiency diseases and schistosomiasis mansoni overlap. An experimental model, which reproduces the marasmatic clinical form of protein-energy malnutrition, was developed in this laboratory to study these interactions. Albino Swiss mice were fed with a food association ingested usually by human populations in northeast Brazil. This diet (Regional Basic Diet - RBD) has negative effects on the growth, food intake and protein utilization in infected mice (acute phase of murine schistosomiasis). Nitrogen balance studies have also shown that infection with Schistosoma mansoni has apparently no effect on protein intestinal absorption in well nourished mice. However, the lowest absorption ratios have been detected among RBD--fed infected animals, suggesting that superimposed schistosome infection aggravated the nutritional status of the undernourished host. The serum proteins electrophoretic pattern, as far as albumins are concerned, is quite similar for non-infected undernourished and infected well-fed animals. So, the significance of albumins as a biochemical indicator of the nutritional status of human populations residing in endemic foci of Manson's schistosomiasis, is discussable.

Acute Disease↗
PubMed1991

Effects of hydrocortisone acetate treatment on the small intestine of the lactent marsupial Didelphis albiventris.

When hydrocortisone acetate was administered subcutaneously to the lactent Brazilian white belly opossum, it induced precocious intestinal maturation. Histological features of the small intestine were reminiscent of those seen in human protein-caloric malnutrition. There were also indications that the glucocorticoid acted as an inducer of the differentiation of Paneth, goblet and granulomucous cells within the small intestinal epithelium. In the lactent opossum the small intestine is lined by an epithelium containing cells which exhibit intense endocytic activity (Krause et al. 1977; Santiago et al. 1983; H.B. Coutinho, Beck--unpublished) verified that subcutaneous injections of hydrocortisone acetate could determine intestinal closure in lactent opossums. Krause et al. and Santiago et al. have reported that in Didelphis virginiana and Didelphis albiventris, respectively, the goblet cells and Paneth cells differentiate lately in the development of pouch opossum young. Freitas et al. (1982) mentioned that the plasma cortisol level was very low in lactent white belly opossum, but preceding weaning there was an abrupt increase of the plasma cortisol reaching levels comparable to that obtained in adult animals. These facts suggested the need for investigations to clarify if cortisol could act as an inductive agent for the differentiation of goblet cells and Paneth cells in the lactent D. albiventris.

Animals↗
PubMed1990

Treatment of large fibroids with high doses of gestrinone.

Twenty-four women with large, myomatous uteri, measuring between 218.7 and 2,920 cm3 were treated with gestrinone, a tri-enic steroid with antiestrogen and antiprogesterone properties. In order to saturate the receptors of the large myomata, the doses used to treat these women were twice the recommended dosage of 2.5 mg, 3 times weekly, used to treat smaller tumors. The treatment lasted 6 months to 1 year. In all cases there was a reduction in uterine volume. In the 24 patients, the mean uterine volume of 724.9 cm3 on admission decreased to 450.73 cm3 at 6 months. For 14 patients treated for a full year, the mean uterine volume of 689.73 cm3 decreased to 329.22 cm3. Menstruation was suppressed in all patients by the end of the 2nd month of treatment. Episodic bleeding occurred in 6 patients but in only 1 did this last longer than 1 week. Other symptoms such as pelvic discomfort and dysuria disappeared or were significantly alleviated by the 2nd month of treatment. Side effects included seborrhea, acne, nervousness, myalgia and arthraglia, hoarseness and mild hirsutism but all these symptoms were promptly reversed following discontinuation. The mean increase in weight was 3.4 kg in 6 months. No menopausal symptoms such as hot flushes and depression developed during this trial. Six patients complained of excessive sweating. Blood glucose creatinine, blood urea nitrogen, alkaline phosphatase, pyruvic and glutamic transaminases remained within the normal range.

Adult↗