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The aim of this study was to evaluate the effects of transdermal hormone replacement therapy on some biological cardiovascular risk factors, specifically the thromboxane B2 levels, plasma viscosity and the lipid profile. Furthermore, we investigated the Doppler flow modifications at the level of the uterine artery, the internal carotid, the ophthalmic and the bladder wall arteries, and we finally evaluated whether there were significant differences in the examined parameters between normal and overweight postmenopausal women. Forty-five postmenopausal women (mean age+/-standard deviation, 53.5+/-3.8 years) participated in the study and were divided into two groups (27 with a body mass index of < 25 kg/m2 and 18 with a body mass index of > 25 kg/m2). Patients were treated with a continous estradiol transdermal supplement and a 12-day course of medroxyprogesterone acetate every 2 months, and were studied at baseline and after 6 months (in the estrogen-only phase of the second cycle). Our results showed a beneficial effect of hormone substitution on plasma viscosity, thromboxane B2 levels and lipid profile after 6 months of therapy and significant improvements of Doppler flow parameters in the examined vessels. Furthermore, we observed a lower impact of the treatment in overweight women. In conclusion, obesity represents an additional cardiovascular risk condition and it can only partially be modified by the administration of hormone replacement therapy.

Objective: To compare the plasma thromboxane, the plasma viscosity and the Doppler flow modifications induced by tibolone and by oral or transdermal continuous combined hormone replacement therapy., Methods: Forty-two post-menopausal patients underwent either on: oral daily treatment with tibolone (2.5 mg) (Group I; n= 14); or continuous oral administration of 0.625 mg conjugated equine estrogens + medroxyprogesterone 5 mg per day (Group II; n = 14 ); or continuous estradiol transdermal supplementation, at a dose of 50 microg per day, + medroxyprogesterone 5 mg per day (Group III; n = 14 ). The duration of the study was 6 months and the patients were submitted to transvaginal ultrasonographic evaluation of pelvic organs; Doppler analysis of the uterine, internal carotid and ophthalmic arteries; thromboxane and plasma viscosity assays in basal condition, and at 1, 3 and 6 months from the beginning of the study., Results: Although the endometrial thickness increased significantly, there were no cases in which it exceeded the normal range (< or = 5 mm). In all the three groups, the pulsatility index of the uterine, internal carotid and ophthalmic arteries significantly decreased during the therapy showing a reduced impedance since the first month of treatment. Similar variations were observed for the peak systolic blood flow velocity of the internal carotid and ophthalmic arteries. Hormone replacement therapy and tibolone induced a deep, significant and rapid decrease in plasma thromboxane and plasma viscosity levels., Conclusions: Hormone replacement therapy and tibolone seem to have beneficial effects on vascular and hemorrheological parameters.

Objective: To compare semen parameters and intracytoplasmic sperm injection (ICSI) outcome in spinal cord-injured subjects who underwent single (group 1) or multiple (group 2) electroejaculations before ICSI., Design: Prospective, randomized, controlled study., Setting: Department of gynecology, obstetrics, and pediatric science in a reproductive medicine unit at a major Italian university., Patient(s): Thirty-four healthy women with a male partner with SCI who were seeking assisted reproduction services., Intervention(s): Transrectal electroejaculation, controlled ovarian hyperstimulation, and ICSI., Main Outcome Measure(s): Sperm concentration, morphology, and motility and fertilization and pregnancy rates after ICSI., Result(s): Sperm was successfully retrieved in 94.1% of cases. In male subjects who underwent multiple electroejaculations, statistically significant improvements in sperm concentration and total sperm motility rate were observed. The overall fertilization rate was 63.6%. The number of oocytes retrieved and injected was comparable between the two groups. A total of nine clinical pregnancies were achieved. The pregnancy rate was statistically significantly higher in group 2 (n = 6/16; 37.5%) than in group 1 (n = 3/16; 18.75%)., Conclusion(s): These data suggest that multiple electroejaculation has a positive effect on semen parameters and ICSI outcome.

Objectives: To provide epidemiological data about psychological symptoms derived from a large Italian non-clinical sample, and to investigate the correlation with psychosocial factors., Methods: The study design was a cross-sectional postal survey of a sample of menopausal women recruited from the General Registry Office in Ferrara's province. Four thousands and seventy-three women were sent a questionnaire designed on the basis of the Women Health Questionnaire (WHQ). Together with the WHQ, women were asked to fill out a personal file to define social status, cultural level, family's characteristics, recent menstrual cycles, gynaecological history and operations, drug's assumption, life events in the last year and lifetime depression., Results: Factor analysis resulted in eight clusters of symptoms. Among psychiatric symptoms, three different clusters were identified: depressive symptoms, depressed mood with anxiety symptoms, and anxiety. The cluster "depressive symptoms" was more evident in the postmenopausal period with respect to the premenopausal one., Conclusion: The cluster "depressive symptoms" is significantly different in the premenopausal group with respect to the postmenopausal group, with greater levels of symptomatology in the postmenopausal group. On the contrary, the factor "depressed mood with anxiety symptoms" is present to the same extent in the pre-, peri- and postmenopausal groups. Prior depression is the most predictive variable of subsequent depression in postmenopausal women. Factors related to more pronounced depressive symptoms are number of life events, postmenopausal status, place of residence in rural areas and lower cultural level.

Objectives: Postmenopausal osteoporosis is becoming a major problem for healthcare institutions as it has a growing social and economic impact. The incidence of osteoporotic fractures is constantly increasing due to the increase in life expectancy. The gynaecologist plays an important role in establishing a "biological zero" in each perimenopausal patient, and controlling the rate of bone loss during postmenopausal period., Results: Dual energy X-ray absorptiometry (DXA) has been widely used for the diagnosis and management of osteoporosis and represents a strong risk factor for fractures, but it presents several limitations with regards to diagnosis, treatment follow-up and differential diagnosis of secondary osteoporosis. In these last years quantitative ultrasound (QUS) technique has been introduced for the evaluation of bone status in postmenopausal women and several in vitro and clinical studies have demonstrated the reliability of the examination in terms of: reproducibility, evaluation of fracture risk, treatment follow-up, differential diagnosis. QUS has proven to be equally capable in the prediction of future osteoporosis related fractures in comparison to DXA. Large-scale cross-sectional and longitudinal studies have demonstrated the applicability of QUS in screening the female population during the climacteric period. QUS technique seems to be very efficient in identifying "fast losers", identifying subjects at risk for osteoporosis requiring second-level investigation (DXA, X-ray), diagnosing secondary osteoporosis., Conclusion: If QUS is used in a systematic and rational manner in clinical practice, it is a valid technique for the prevention of osteoporosis in postmenopausal women.

Osteoporosis involves alterations, not only in density, but also in the architectural organisation of the bone; in particular, trabecular orientation, following the skeletal load directions, lends a high degree of stiffness to the whole bone. We investigated the relationship between trabecular orientation, density, stiffness and ultrasound (US) propagation in two orthogonal directions (par. = parallel to, and ort. = orthogonal to the main orientation of the trabeculae) in cylindrical equine bone specimens (thoracic vertebrae) where a preferential orientation is present. A total of 15 cylinders were progressively decalcified with 0.2 mol/L ethylenediaminetetraacetic acid (EDTA). At different levels of decalcification, we measured the apparent density (g/cm(3)), bone mineral density or BMD (g/cm(2)), stiffness coefficient (MPa) and various US parameters. Before decalcification, stiffness values were the same in all directions. As the decalcification proceeded, the stiffness declined and, at low BMD values, it was significantly different in the two directions, being the highest in the par. one. Different behaviours of US parameters were observed in the two directions: SoS (speed of sound) was closely related to apparent density, BMD and stiffness in the par. direction (r = 0.88, 0.92 and 0.88, respectively, p < 0.0001). In the ort. direction, no significant association has been found between SoS and apparent density, BMD or stiffness. In the same experimental setup, US fast wave amplitude (FWA) was related to apparent density and BMD in the par. direction (r = 0.72 and 0.67, respectively, p < 0.0001) and in the ort. direction (r = 0.83 and r = 0.84 respectively, p < 0.0001). FWA was also correlated to stiffness in both directions (r = 0.61 par.; 0.81 ort., p < 0.0001). These results show that trabecular orientation strongly influences both mechanical properties of bone and US propagation. Furthermore, we found that US parameters can be predictors of mechanical properties of the bone independent of bone density.

Vaginal innate immunity in response to microbial perturbation is still poorly understood and could be crucial for protection from adverse outcomes. We investigated the relationship between interleukin (IL)-8, IL-1beta and neutrophils in vaginal fluid obtained from 60 healthy women and 51 women who were bacterial vaginosis (BV) positive. Concentrations of IL-8 and IL-1beta were highly correlated with counts of neutrophils in vaginal fluid of the entire population examined (111 subjects). Vaginal IL-1beta concentrations were significantly higher (P < 0.001) in BV positive women. There was no significant difference in IL-8 levels or number of neutrophils between healthy controls and BV positive women. None of the healthy controls with high neutrophil counts (> or =75th percentile, 14 average count per field) had high concentrations of IL-1beta (> or =75th percentile, 220 pg/ml), whereas 84% of BV positive women with high neutrophil counts had high IL-1beta concentrations (P < 0.001). On the contrary, no difference in the percentage of subjects with elevated concentrations of IL-8 (> or =75th percentile, 2842 pg/ml) was found between healthy and BV positive women with high numbers of neutrophils (55.5% of healthy versus 53% of BV positive women). Our findings show that BV causes a large increase in IL-1beta concentrations which is not paralleled by an increase in IL-8 concentrations in vaginal fluid, suggesting that BV-associated factors more specifically dampen IL-8 rather than IL-1beta. The lack of an increase in IL-8 may explain the absence of an increase in neutrophil numbers in most women exposed to abnormal vaginal colonization (BV).

Our aim was to evaluate the prevalence of bacterial vaginosis and decrease in lactobacillus colonization in women 40 years old or older in relation to menopausal status by evaluation of Gram-stained smears. A total of 1,486 smears from Italian Caucasian women aged 40 to 79 years were examined. Women were classified as follows: fertile (regular cycles) (n = 328), perimenopausal (irregular cycles) (n = 237), and postmenopausal (n = 921), including 331 women on estroprogestinic hormone replacement therapy (HRT). The prevalences of bacterial vaginosis (assessed as a Nugent score of >or=7) in fertile (9.8%) and perimenopausal (11.0%) women were not statistically different, whereas the prevalence was significantly lower overall in postmenopausal women (6.0%) (P = 0.02). Specifically, 6.3% of postmenopausal women without HRT and 5.4% of postmenopausal women with HRT were positive for bacterial vaginosis. The Nugent score system was not adequate for evaluating the normal and intermediate vaginal flora in women over the age of 40 years. High numbers of peri- and postmenopausal women had no lactobacilli and no bacterial-vaginosis-associated microorganisms. This nonpathological absence of lactobacilli in women with a Nugent score of 4 was scored as 4*, and this group was considered separately from the intermediate flora group. A score of 4* was obtained for 2.1% of fertile women, 11.4% of perimenopausal women, 44.1% of postmenopausal women without HRT, and 6.9% of postmenopausal women with HRT. The physiological reduction in lactobacillus colonization of the vagina in postmenopausal women does not cause an increase in bacterial-vaginosis prevalence. Reversion of lactobacillus flora to premenopausal levels due to HRT does not increase the prevalence of bacterial vaginosis in postmenopausal women.

Objectives: To assess differences in two sequential combined hormone replacement therapy (HRT) products on selected cardiovascular and breast metabolic markers. The products were different concerning the route of administration of estradiol and its combined progestin, either oral or transdermal, and the androgenic properties of progestogens, respectively, dydrogesterone and norethisterone acetate., Methods: One hundred and nineteen healthy non-hysterectomized postmenopausal women were included in this open, multi-center, two parallel group trial. They were randomized to a treatment of six 28-day cycles with oral estradiol sequentially combined with dydrogesterone (oE2/D10) or a sequential combination patch of estradiol plus norethisterone acetate (tdE/NETA). At baseline and after six cycles the high-density lipoprotein cholesterol (HDL-C), the sex hormone binding globulin (SHBG) and the total insulin-like growth factor-I (IGF-I) blood levels were determined by a central laboratory. A total of 89 women were compliant to the protocol., Results: After six cycles, a statistically significant difference (P<0.001) concerning HDL-C, SHBG and IGF-I levels was found between the two treatment groups. The HDL-C levels were increased in the oE2/D10 group and decreased in the tdE/NETA group, with a final difference of about 0.3 mmol/l. The oE2/D10 treatment induced a sharp increase (about 57 mmol/l) in SHBG levels. IGF-I levels decreased with both the products, but the difference in favor of the oE2/D10 treatment was of about 30 ng/ml. Moreover, patients on tdE/NETA with an IGF-I baseline value below the median showed an increase., Conclusion: Oral estradiol sequentially combined with dydrogesterone, a non-androgenic progestogen, induced positive changes of some cardiovascular (HDL-C) and breast (SHBG and IGF-I) metabolic markers. These effects were significantly different from those obtained with a transdermal estradiol associated to an androgenic progestogen.

Background and Aim: Postmenopausal modification of the lipid profile plays a major role in the risk of ischemic heart disease. Lifestyle counseling and estrogen replacement therapy have all been proposed as first-line measures, but there is no agreement on the best way to treat climacteric dyslipidemia. Soybean-based diet seems particularly attractive in this context, given its cholesterol lowering potential, its hypothetical anticancerous effects and possible modification of climacteric symptoms., Methods and Results: We evaluated the effect of 60 g isolated soy protein (ISP) daily on the lipid profile of 104 postmenopausal women (53.3 +/- 3.3 years) in a double-blind, parallel, placebo-controlled (caseinate) trial, as part of a broader assessment of the effect of ISP on climacteric symptomatology. Serum total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apo A-I, apo B and lipoprotein (a) were determined before and after a 12-week diet modification. Seventy-seven women completed the trial. Both soy and placebo determined a significant reduction in total cholesterol (-0.42 +/- 0.79 and -0.40 +/- 0.57 mmol/L) and LDL-cholesterol (-0.35 +/- 0.72 and -0.31 +/- 0.54 mmol/L), but only soy had a significant lowering effect on apo B and the LDL-cholesterol/HDL-cholesterol ratio (-6% and -8% from baseline respectively); lipoprotein (a) plasma levels were not significantly changed by either treatment. Forty-four women were dyslipidemic at baseline; those with increased LDL concentrations showed a somewhat greater improvement in their lipoprotein profile (LDL-cholesterol and apo B reduction) with soy rather than placebo. No further information emerged when the subjects were divided into three apo E phenotypes., Conclusions: We conclude that diet supplementation with 60 g ISP is slightly better than caseinate in favorably modifying the lipoprotein metabolism of postmenopausal women; this effect is more evident in hypercholesterolemic subjects.

Two estradiol (E2) transdermal patches releasing 25 micrograms/day E2 (D-25) or 37.5 micrograms/day E2 (D-37.5) were compared to a placebo patch on 156 patients in natural or surgical menopause suffering from at least 5 hot flushes per day, randomly and blindly assigned to three parallel groups of 52 patients each, to be treated continuously for 12 weeks, without progestin opposition. "Responders" (patients with less than 3 hot flushes per day at the end of treatment), were 82% and 90% under D-25 or D-37.5, respectively, both significantly (p < 0.001) more than under placebo (44%). Comparable efficacy was observed on severity of hot flushes, Kupperman Index and on the self-rated efficacy. Systemic adverse events occurred in 10%, 10% and 8% of patients, respectively, under D-25, D-37.5 or placebo. Occasional mild and transient itching and/or erythema on the site of application was reported by few patients and did never require discontinuation of application. In conclusion D-25 and D-37.5 were significantly more effective than placebo in relieving climacteric symptoms and were systemically and locally as well tolerated as placebo. D-25 (Demestril 25) releasing 25 micrograms/day E2 can therefore be recommended for low-dosed estrogen replacement therapy.

Objective: To identify the determinants of age at menopause in an Italian population, using data from the Italian Climacteric Research Group Study (ICARUS)., Methods: ICARUS is a prospective study of the effect of menopause on women's health that has been running in menopause clinics throughout Italy since 1995. A total of 4300 women with spontaneous menopause, aged 55 years or more and observed for the first time at the participating centres are included in the present analysis., Results: The mean age at menopause in the total population was 50.9 years. After taking into account potential covariates, the women reported smoking, had a slightly lower mean age at menopause than non smokers 50.4 versus 50.9 years; P = 0.01. The mean age at menopause in nulliparae was 50.0 years, and, respectively 50.4, 50.6, 50.9, 51.2 and 50.9 years in those reporting 1, 2, 3, 4 and 5 or more births (P < 0.01). A low body mass index and an early age at menarche were associated with early menopause in the crude analysis, but these associations disappeared after taking into account the confounding factors., Conclusions: This study offers an estimate of the mean age at menopause of women attending menopause clinics in Italy, on the basis of the data obtained from a large sample. It also indicates that smoking and nulliparity are associated with early menopause.

There is increasing evidence from epidemiological studies that exogenous estrogen (hormone replacement therapy) protects against the elevated risk of cardiovascular disease in women after the menopause. However, it is still uncertain whether the postmenopausal decrease in endogenous estrogen in itself contributes significantly to this increase in risk. Most of the studies that have provided evidence linking cardiovascular disease with menopause have involved North American women, who may differ significantly from Europeans in terms of lifestyle and diet. ICARUS (Italian Climacteric Research Group Study) is an observational study that involves Italian Menopause Clinics, with the objective of collecting observational data on menopause and its management. The results of a cross-sectional analysis of 9309 women, free from any hormonal treatment and enrolled up to March 1997, are reported here. Data show that the menopause has a marked effect on the circulating levels of lipids and lipoproteins. From pre- to post-menopause there are significant increases in total cholesterol (6.9% before and 4.4% after adjustment for covariates including chronological age, educational level, center, BMI, smoking habits, hypertension and diabetes, previous contraceptive use, and time since menopause), LDL (7.5% before, 4.0% after), and triglycerides (9.0% before, 3.2% (ns) after). However, there is no significant change in HDL. Among postmenopausal women, no effect on lipid profile of time since menopause was observed.

Objectives: To evaluate and to compare the bleeding patterns obtained with two regimens of hormone replacement therapy given to early postmenopausal women with asymptomatic uterine leiomyomas., Methods: In this randomised prospective 1-year study 50 early postmenopausal women with one to four asymptomatic uterine leiomyomas were enrolled into two study-groups to take two regimens of hormone replacement therapy for 12 28-day cycles: (A) Tibolone, 2.5 mg/day; (B) conjugated equine estrogens (CEE), 0.625 mg/day plus medroxyprogesterone acetate (MPA), 5 mg/day. The bleeding patterns and the changes in uterine volume of the 47 outpatients who completed the study were evaluated and compared., Results: Amenorrhea incidence was higher in group A (75.0% of the cycles) than in group B (65.6% of the cycles), while irregular bleeding and irregular spotting incidences were higher in group B (29.7 and 4.7% of the cycles, respectively) compared to group A (22.6 and 2.4% of the cycles, respectively). The mean bleeding and spotting lengths were not statistically different between patients in group A and those in group B. Finally, at the end of the study period transvaginal ultrasonography showed no significant change in leiomyoma size., Conclusions: The results demonstrate that, in early postmenopausal patients with asymptomatic uterine leiomyomas, Tibolone treatment seems to be preferable compared to CEE-MPA continuous combined treatment in relation to the lesser occurrence of irregular bleeding. Furthermore, neither Tibolone nor CEE-MPA therapy, at the doses used here, promote fibroid growth.

Background: The purposes of this paper are to summarise the epidemiological data concerning the frequency of postmenopausal osteoporosis and its related fractures in Emilia-Romagna, a province of northern Italy, and to determine the future impact of this disease., Methods: To evaluate how many people suffer from postmenopausal osteoporosis it was decided to calculate the number of hospital admissions due to this disease or to its related fractures in postmenopausal women--included and excluded according to the ICD9-CM codes relative to the hospital discharges--during the years 1994 and 1995., Results: The results show that incidence rates of these hospital admissions increase with age, as well as the number of osteoporotic fractures. Hip fractures, which represent a major problem due to their costs and consequences, are the more frequent osteoporotic fractures which need hospital admission, while it is possible that a large part of other fractures (which do not need hospitalisation or have been treated in private structures) has not been calculated., Conclusions: When projected to the population of women living in Emilia-Romagna in the future decade, also keeping the age-specific fracture rates constant, these data suggest that the occurrence of postmenopausal osteoporosis and of osteoporotic fractures will increase, with a dramatic escalation of economic and human costs. Finally, direct costs related to postmenopausal osteoporosis have been calculated for the decade 1995-2004.

Carbocalcitonin spray administered for 12 months at a daily dosage of 80 U MRC according to five schedules has been tested on 150 normal spontaneous postmenopausal women for its influence on bone mineral density (BMD), bone metabolism and osteoarticular pain. BMD was monitored before and at the end of treatment in comparison with BMD of untreated control women. Metabolic markers (serum alkaline phosphatase, serum osteocalcin and urinary hydroxyproline) were also evaluated before and during treatment (at the 9th or 10th month of treatment). Osteoarticular pain was assessed by an analogic visual scale. Intranasal carbocalcitonin, administered according to cyclic schedules at a high frequency dosage, was able to maintain bone mass only in the earlier postmenopausal women. BMD percent increase after 12 months of treatment was 1.10 and 1.31 in women with low (< 0.870 mg/cm2) and high baseline BMD (> or = 0.870 mg/cm2), respectively. In advanced menopause the maintaining effect of carbocalcitonin on BMD seemed evident only if the baseline bone mass was lower than the BMD of the age matched control group. At least six months of treatment/year is necessary for effective therapy. Both systemic and local tolerance were optimal. No significant side-effects were detected.

A placebo-controlled trial to evaluate the efficacy and the safety of intramuscular injection of interferon-beta has been performed on 37 patients suffering from cervical intraepithelial neoplasia II (CIN II) associated with human papillomavirus (HPV) infection of the cervix: twenty-two patients were treated with interferon-beta (2 x 10(6) I.U. daily) for ten days; fifteen received placebo (2 ml of saline solution daily) for ten days. Prior to therapy, and at day 70, 190, 370, 550, 730 after the beginning of treatment, patients were examined by colposcopy and punch biopsies of the cervix. Results showed a progressive amelioration in the interferon-beta treated patients, which was statistically significant at any control station (70, 190, 370, 550, 730 days) as compared to placebo treatment. Percentages of lesions that regressed, persisted or progressed were 36.4%, 54.5%, 9.1% respectively in the Interferon-beta group, and 0%, 67.7% and 33.3% respectively in the placebo group. Interferon-beta administered intramuscularly has shown to be an efficacious treatment of CIN II (cervical intraepithelial neoplasia II) associated with HPV infection, without evident side effects; it can be used in patients requiring medical treatment with at least one-year monitoring by cervical biopsies or as an adjuvant surgical treatment (which remains the principal treatment) in the management of patients suffering from CIN II associated with HPV infection.

The Authors evaluated the effects and tolerability of iron acetyl transferrin in fifty women affected by anemia for want of iron. The patients were given oral iron treatment (80 mg/die) for 30 days; commonest haematologic parameters were examined (RBC, HTC, MCV, MCH, serum iron, ferritin, transferrin) before and after treatment. The results show that iron acetyl transferrin has an excellent therapeutic effect and a good tolerability.

Three hundred and sixty-three postmenopausal women received 6 months of cyclic hormone replacement therapy with conjugated estrogens in differing doses (0.625 mg and 1.25 mg) associated in a sequential pattern lasting 12 days with progestagens (medroxyprogesterone acetate or medrogestone) in 16 italian health centres. The results of the multicentre study confirm the efficacy of this conjugated estrogen-progestogen regimen in resolving climacteric syndrome, offering cardiovascular protection and vaginal trophic effect and preventing postmenopausal osteoporosis, as well as confirming its tolerability in relation to blood pressure, body weight, breast, endometrium, blood coagulation and hepato-renal function.

Objective: To evaluate the antiemetic effect of acupressure at the Neiguan point., Methods: Sixty women in early pregnancy were entered into a randomized, double-blind, cross-over, placebo-controlled trial. During a 12-day period, organized in four steps of 3 days each, the women were divided into two homogeneous groups to test the effectiveness of unilateral and bilateral acupressure., Results: Use of acupressure resulted in a significantly lower frequency of morning sickness compared with placebo treatment. More than a 60% positive effect was found with unilateral and bilateral acupressure, compared with an approximately 30% positive effect of placebo acupressure. Changing from unilateral to bilateral pressure on the Neiguan point caused no significant statistical difference. No noteworthy side effects occurred., Conclusion: Acupressure on the Neiguan point relieves morning sickness.

Tetridamine (2-methyl-3-methylamino-4,5,6,7-tetrahydroindazole) is a well known analgesic and anti-inflammatory drug. Here the activity and the tolerability of a new 0.134% tetridamine formulation in rats and women, are reported. Anti-inflammatory and analgesic tests were performed in Sprague-Dawley rats with carrageenin oedema; topical application of 0.134% tetridamine solution showed a marked reduction of paw swelling (-54.4%) and pain sensibility (-81.0%). A 28 days vaginal tolerability study performed on Sprague-Dawley rats with tetridamine lavage (0.2 ml/rat/day) showed, in comparison with control group, no changes in haematology, coagulation, clinical biochemistry and in histological examinations of uterus and vagina. Clinical studies (4 open and 1 double-blind) were performed on 93 women suffering from vulvovaginitis and cervicitis by treatment of 0.134% tetridamine vaginal lavage, two times daily, for 7 days. Tetridamine lavage reduced or eliminated all inflammation symptoms like burning, leucorrhea, etc. and resulted very well tolerated. From these pharmacotoxicological and clinical results we can conclude that tetridamine vaginal lavage is a new formulation with high activity and good tolerability.

The seminal and plasmatic concentrations have been examined of testosterone, 5 alpha-dihydrotestosterone, and delta 4-androstenedione in normospermic and dysspermic subjects. The results obtained did not provide evidence of significant differences of androgen levels in fertile, hypofertile and sterile men.

The authors evaluated the diagnostic effectiveness of a triple specimen technique (cyto-histologic) performed by the Perma device. The incidence of endometrial hyperplasia (according to Dallenbach-Hellweg's classification) was estimated in 254 climacteric women selected from outpatients who come spontaneously to the Menopause Clinic of the Obstetrics and Gynecology Department (Bologna University). The selection criterion was the evidence of risk factors for endometrial carcinoma, climacteric bleedings (obesity, late menopause, high blood pressure, diabetes), or endometriotropic estrogen therapy in the postmenopause. Results showed that the cyto-histologic sampling is most useful for diagnosing endometrial hyperplasia and early carcinoma (diagnostic effectiveness: 89.0-93.8%). Also, endometrial hyperplasia was found to have a significant incidence in the group we examined. This incidence was highest in women with climacteric bleedings, secondly in women using high-dose estrogens, and thirdly in women with risk factors for endometrial carcinoma. When evaluating the different kinds of endometrial hyperplasia, we never found adenomatous hyperplasia in women on estrogen therapy. Affinity between histologic and cytologic classes was around 50% in endometrial hyperplasia and 100% in early carcinoma. This emphasizes that both samplings are needed to perform an accurate diagnosis.

The Authors have determined the concentrations of Testosterone, 17beta-oestradiol, FSH and LH by of radioimmunologic assay in blood of seventy normal adult men blood drawn between eight and eleven a.m.) and in blood of thirteen normal adult men blood drawn at eight and twelve a.m., four and eight p.m.). Average values under basal conditions, and circadian variations have been discussed and confronted with those obtained by other authors.

An allergological examination technique for application in patients with a history of hypersensitivity to antibiotics is described with reference to a personal series of 250 subjects admitted to the Bologna University obstetric and gynaecological pathology department for small pelvis surgery. The method of investigation is described and the results obtained are reviewed. It is felt that the investigation is of value in preoperative screening insofar as it eliminates or reduces the risk of allergic shock, and enables more precisely directed antibiotic management to be employed.

The plasma levels of gonadotrophins, androgens (expressed as testosterone) and 17beta-oestradiol in response to GnRH, L-dopa, clomiphene, HCG and HMG administration have been assayed by radioimmunological mehtods in 70 normal adult males. In keeping wih findings reported in the literature, the results obtained confirm the usefulness of dynamic stimulation with GnRH, clomiphene, and HCG in andrology for the purpose of evaluating the efficiency and integrity of the hypothalamic-pituitary-testicular system and of its individual glandular components. On the other hand, the administration of L-dopa and HMG does not appear to yield clinically useful findings.

Twenty-five female patients, aged 14 to 49, and suffering from syptoms of virilization (hirsutism, acne, seborrhea and alopecia) were treated with an estrogen-progestogen combinantion, i.e. cyproterone acetate and ethinylestradiol, having antiandrogenic and antiovulatory action. Patients were submitted to monitoring by means of a series of laboratory tests in order to detect any toxic or hormonal effects that might occur. In most cases symptoms of virilization were significantly reduced, while untoward side effects were not noted.

Radioimmunological methods have been used to assay the plasma concentrations of gonadotropins, androgens (expressed as the sum of testosterone and dihydrotestosterone) and 17beta-oestradiol in 98 patients suffering from dysspermia of variable etiology, after stimulation with GnRH, Clomiphene, L-Dopa, Cyclophenyl, HCG in various dosage schemes, and HMG. Results show L-Dopa and HMG tests to be of little value in assessing the endocrine function in infertile men. They also confirm, in keeping with data found in the literature the usefulness of dynamic stimulation with GnRH, Clomiphene, and HCG for purposes of andrologic diagnosis. The GnRH proved useful for the distinction between primary and secondary hypogonadotropism as well as for assessing the therapeutic efficacy of releasing factors. The functional efficacy of the endocrine axis which is often impaired in patients with dysspermia can be evaluated by the Clomiphene test. In the small number of cases in which it was applied, Cyclophenyl brought about changes in gonadotropin concentration which require further study. The HCG tests, to be performed in patients with lower than normal testosterone plasma lavels, permits the discrimination between primary and secondary Leydig cell deficiencies as well as the assessment of interstitial tissue sensitivity to chorionic gonadotropin stimulation. Of the three dosage schemes (5000 IU, 7500 IU "step up", 10.000 IU) the last one is most suitable for clinical use.

The clinical use of testosterone, and more recently of orally administered mesterolone in disorders of male fertility is of limited therapeutic efficacy, as shown by data found in the literature. On the basis of these considerations, the authors have tested mesterolone cyclopentylproprionate in 15 subjects suffering from sperm disorders. The drug, which is slowly released in the tissues has been parenterally administered at a total dose of 1,200 mg (100 mg per week). During the therapeutic trial the following aspects have been studied: spermiologic and hormonal patterns, general conditions, libido, principal organic functions and the possible side effects. Results are critically evaluated.

The serum gonadotropin response to LH-RH (100 mug e.v.) in a group of women with various types of amenorrhea was critically evaluated. Most patients responded to rapid LH-RH injection with a significant rise in plasma LH and FSH. In the authors' opinion this response is observed in healthy women as well as in those with lesions, even severe ones, of the pituitary, so that quantification of the response does not supply reliable information on diagnosis and prognosis. On the other hand, a negative response to the injection of 100 mug LH-RH does not necessarily imply a pituitary lesion but is often a sign of altered hypothalamic function which can be diagnosed and in some instances restored by clomiphene administration.

The plasma concentration of delta4-androstenedione has been assayed by a radioimmunological method, preceded by chromatographic purfication, in 11 normal adult and 4 adult castrated males at various times of day. The circadian variations observed are critically evaluated.

130 male subjects (61 with asthenospermia, 69 with oligoasthenospermia) classified according to spermiologic patterns have been treated with different therapeutic outlines (gonadotrophins, antibiotica, arginine aspartate high levels, their associations); 89 subjects have been undergone with arginine aspartate, 41 without arginine aspartate. The results have been critically examined in order to different therapeutic outlines, to spermiogram, to diagnosis, to use of arginine aspartate in different spermiologic alterations, to use of arginine aspartate with respect to control groups, to arginine aspartate levels.