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Biomedical subjects

J C Colau

Publications and source records attributed to J C Colau.

At least 19 recordsLinked to original sources
PubMed2000

Clinical equivalence of intranasal and oral 17beta-estradiol for postmenopausal symptoms.

OBJECTIVE: The aim of this study was to demonstrate clinical equivalence between a novel intranasal estradiol formulation and a reference oral drug. STUDY DESIGN: In this multinational, double-blind, parallel-group study 659 postmenopausal women with moderate to severe postmenopausal symptoms were randomly assigned to receive either 300 microg/d intranasal 17beta-estradiol (S21400) or 2 mg/d oral micronized estradiol, plus the appropriate placebo, for 24 weeks. All patients also received 10 mg/d dydrogesterone for 14 days per 28-day cycle. Adjustment of intranasal dosage was permitted from week 14 on. The primary efficacy criterion was the Kupperman index at week 14, with a predefined limit of equivalence of 4. RESULTS: Kupperman index scores improved similarly in the 2 groups, from 28.4 +/- 6.2 to 10.0 +/- 8.6 (mean +/- SD) for S21400 and from 28.1 +/- 6.0 to 8.9 +/- 8.0 for oral therapy, with a difference between groups at week 14 of 1.1 +/- 0.6 (90% confidence interval, 0. 0 to 2.2). This was below the predefined equivalence limit of +4 for statistical noninferiority (P <.001). The daily number and intensity of hot flushes decreased similarly in the two treatment groups. Withdrawal bleeding was 20% less frequent with intranasal therapy (90% confidence interval, 12.5 to 27.6). Severe mastalgia was less frequent in the S21400 group (1.0%) than in the group with oral therapy (5.2%; P <.01). Triglyceride and angiotensinogen levels increased significantly with oral therapy but not with S21400. The same number of patients required dose adaptation in the 2 groups (approximately 20%). CONCLUSION: Intranasal administration of 300 microg/d estradiol was at least as effective as oral administration of 2 mg/d estradiol in alleviating postmenopausal symptoms, with less frequent mastalgia and uterine bleeding and without the metabolic consequences of the first-pass effect.

Administration, Intranasal↗
PubMed2000

Local spermicidal contraception: a comparative study of the acceptability and safety of a new pharmaceutical formulation of benzalkonium chloride, the vaginal capsule, with a reference formulation, the pessary.

OBJECTIVE: To evaluate comparatively the acceptability and safety of a new pharmaceutical form of benzalkonium chloride, the vaginal capsule, with the pessary form. METHODS: Eighty-nine women were randomized to receive either a benzalkonium chloride vaginal capsule or a benzalkonium chloride pessary prior to sexual intercourse according to an open cross-over design over a 2-month study period. RESULTS: The discomfort caused by delayed leakage or discharge was mild. The mean scores for subjective signs (burning, itching, vulvar pruritus) were also mild and were comparable for the two formulations. The capsule appeared to be slightly superior to the pessary regarding discomfort caused by immediate discharge or leakage, ease of use and acceptance by the woman's partner. Local safety was generally good. Adverse events consisted chiefly of vulvar pruritus and a vaginal or vulvar burning sensation, with a higher incidence being associated with the pessary than the capsule. All symptoms regressed spontaneously after the end of treatment. CONCLUSIONS: This study demonstrated good acceptability and good local safety for the benzalkonium chloride vaginal capsule. It is essential to take these parameters into consideration in the evaluation of any local spermicidal contraceptive, since they play a large part in compliance with, and thus in the efficacy of, the product under assessment.

Administration, Intravaginal↗
PubMed2000

[Contraception].

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Cardiovascular Diseases↗
PubMed1999

[An MRI study of the normal pelvis in the immediate postpartum period].

PURPOSE: To describe the MR findings of the pelvis in the early post-partum period, after vaginal delivery or cesarean section. MATERIALS AND METHODS: Fifteen asymptomatic patients were imaged using a 1.5 Tesla MR unit between 1 and 7 days following delivery. Eight patients had a vaginal delivery, and seven patients had a cesarean section. RESULTS: The following items were evaluated: uterus size, architecture, and contents; uterine and abdominal wall scars; parametrium; peritoneal cavity; ovarian veins. CONCLUSION: MRI provided a good evaluation of the pelvic changes related to pregnancy and delivery. Knowledge of the normal findings should improve diagnosis of early post-partum complications.

Abdominal Muscles↗
PubMed1996

Maternal serum human chorionic gonadotropin level at fifteen weeks is a predictor for preeclampsia.

OBJECTIVE: Our purpose was to study the correlation between maternal serum human chorionic gonadotropin levels measured at 15 to 18 weeks of amenorrhea and pregnancy-induced hypertension, preeclampsia, and small-for-gestational-age neonates. STUDY DESIGN: Prospective trisomy 21 human chorionic gonadotropin screening data from 5776 patients were examined in a retrospective investigation of the relationship between human chorionic gonadotropin and pregnancy-induced hypertension (234 cases), preeclampsia (34 cases), and small-for-gestational-age neonates (238 cases). RESULTS: Maternal serum human chorionic gonadotropin (multiples of the median) was higher in the three populations with pathologic disorders. This difference was statistically significant in patients with small-for-gestational-age neonates (p < 0.0163) and preeclampsia (p < 0.0001) but not in those with pregnancy-induced hypertension. In the preeclampsia subgroup, with a cutoff value of 2 multiples of the median, specificity was 32% and sensitivity was 10%; with a cutoff value of 1 multiples of the median, specificity was 100% and sensitivity was 50%. CONCLUSION: High maternal serum human chorionic gonadotropin levels at 15 weeks are related to a risk for preeclampsia. Depending on the human chorionic gonadotropin cutoff value, 32% or 100% of preeclampsia patients would be selected. The usefulness of preventive aspirin treatment from the fifteenth week needs more investigation in a larger multicenter study of preeclampsia.

Biomarkers↗
PubMed1996

[Influence of nomegestrol acetate on the improvement of the quality of life induced by estrogen therapy in menopausal women].

Estrogen replacement therapy in postmenopausal women is followed by several benefits including a prompt improvement of quality of life. Due to uterine proliferation induced by prolonged estrogen intake, progestogens are usually associated, on a cyclical basis, in hormonal replacement therapy prescribed to non-hysterectomized women. Persistence of the beneficial effect of estrogen on quality of life, during progestogens intake, was never investigated. We evaluated, through a specific and previously validated questionnaire, the changes in quality of life observed in 351 women recently menopaused, after 6 months of hormonal replacement therapy associating 24 days of estrogens and 12 days of administration of a non androgenic progestogen: nomegestrol acetate. Patients were randomized within two therapeutic groups in which evaluation of quality of life was performed either during the administration of estrogen alone or during administration of estrogen and progestogen. In the two groups, hormonal replacement therapy was followed by a significant improvement (P < 0,001) in quality of life and no significant difference was observed between the changes observed during estrogen or estrogen-progestogen administration. Quality of life indices measured after 6 months of hormonal replacement therapy are within the same range than values previously described in eugonadal women. We conclude that improvement of quality of life induced by estrogen replacement therapy remains unchanged during cyclical administration of nomegestrol acetate.

Drug Therapy, Combination↗
PubMed1996

[Krukenberg tumors. Analysis of a series of 28 cases].

We report a retrospective series of 28 patients with Krukenberg tumors treated at the Gustave Roussy Institute from 1973 to 1990. Mean age of these women was 42 years. The patients were classed into two groups: depending on whether the ovarian metastasis (group 1) or the primary cancer (group 2) was discovered first. The primary tumor was identified in 20 cases (18 cases of linitis, 1 tumor of the cecum, 1 tumor of the appendix). The primary tumor remained unknown in 8 cases. Twenty-seven patients underwent radical total hysterectomy or bilateral adnexectomy. Gastrectomy was possible for 11 of the 18 cases of linitis; hemicolectomy and appendectomy were performed for the cecal and appendicular tumors respectively. Diagnosis of a primary tumor of the appendix was made after systematic appendectomy and of two Krukenberg tumors after systematic bilateral adnexectomy. In the first group of patients, both localizations were treated in 6 cases, one in 12 including 4 because gastrectomy was not initially possible and in 8 because the primary tumor was unknown. In the second group, the two localizations were treated in 7 cases, and one in 2 cases because gastrectomy was not possible. Surgery was not performed in one patient due to diffuse carcinosis. Bilateral ovarian metastases were seen in 26 out of the 28 cases and 26/28 had chemotherapy without any appreciable effect. Bone metastasis predominated (9 cases), followed by pleuropulmonary (5 cases) and liver (3 cases) metastasis. Overall median survival was 20 months; 14 months in the first group and 29 months in the second. Appendectomy and exploration of the colon and the stomach were performed in all cases in which the Krukenberg tumor was discovered intraoperatively. An endosonographic exploration of the stomach is recommended if the primary tumor is not localized. Bilateral adnexectomy should always be performed in patients with linitis whatever the age. Surgical treatment of the two localizations is not always sufficient for cure.

Adult↗
PubMed1995

[Study of amniotic fluid bacterial colonization sampled by amniocentesis in cases with premature rupture of membranes. Prospective multicenter study].

OBJECTIVE: To determine the relationship between bacterial colonization of the amniotic fluid sampled by amniocentesis and premature rupture of the membranes. METHODS: A prospective multicentric study conducted over a one year period in 6 maternity wards in the suburban area of Paris. Thirty-six women with premature rupture of the membranes were studied. RESULTS: There were 11 patients (30%) with contaminated fluid at the first amniocentesis. Twenty-five patients had sterile fluid. In 7 patients with prolonged rupture for more than one week, repeated amniocentesis. Twenty-five patients had sterile fluid. In 7 patients with prolonged rupture for more than one week, repeated amniocenteses were used to follow bacterial colonization. In one patient, Proteus mirabilis in the amniotic fluid was eradicated by adapted antibiotic therapy. In patients with sterile amniotic fluid, there was no secondary colonization. In the 11 cases with colonized liquid, the vaginal swab could only be considered as positive in 4 cases. Amniocentesis was able to discover 7 bacterial colonizations of the amniotic fluid in patients with an indeterminant vaginal swab. Likewise, C-reactive protein levels were raised only in 26% of the cases with a colonized amniotic fluid.

Amniocentesis↗
PubMed1995

[Parvovirus B19 infection and pregnancy].

Parvovirus B19 was identified in 1975. It causes infections megalerythemia in adults associated with skin eruptions and joint pain (about 50% of the adult population is immunized). The risk of contamination in case of an epidemia is high in school teachers and school personnel. In 1984, the parvovirus B19 was implicated as the cause of fetal anasarca. The risk of transplacental contamination is estimated at 33% in case of maternal infection. Pregnant women with parvovirus B19 infection and confirmed serology should have an echography every 15 days. Fetal anasarca can be complicated by in utero fetal death related to erythroid stem-cell anaemia. The diagnosis of fetal infection is based on PCR techniques on fetal blood. Symptomatic antenatal treatment with in utero transfusion was proposed as early as 1988. This method does not however appear to be necessary in all cases as the outcome in several reports of untreated fetuses was delivery of a normal child. There is the possibility of myocardial damage caused by parvovirus B19 which would make in utero transfusion difficult and limit its beneficial effect. Finally associated thrombopenia is often severe and increased fetal risk.

Erythema Infectiosum↗
PubMed1995

[Pregnancy after diagnosis of menopause].

Menopause is a probability diagnosis. Menopause does not mean permanent infertility, particularly in the case of premature menopause. We have realised a national enquiry in order to precise the pregnancy phenomenon after diagnosis of menopause. We found 116 pregnancy cases, which occurred 2.4 years (average) after menopause diagnosis. Pregnancies occur more often in the case of premature menopause and seem to be favoured by hormonal replacement therapy.

Adult↗
PubMed1994

[Gynecology and obstetrics in ancient Egypt].

We analyzed scriptural and archeologic sources of information concerning gynaecology and obstetrics as practiced in ancient Egypt. Knowledge of anatomy was rudimentary but precocious diagnosis of pregnancy was practiced. An obstetrical chair had been used since the VIth dynasty. The Egyptians were the first to describe prolapsus of the genital organs. The pessary was a known treatment. Spermicidal mixtures were used for contraception.

Delivery, Obstetric↗