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OBJECTIVE: To confirm the effect of postmenopausal hypoestrogenism and hormone therapy (HT) on body composition and serum leptin levels. DESIGN: Prospective, longitudinal study evaluating body composition (body mass index, and total and percent fat mass and lean mass measured at the arms, legs and trunk) with dual-energy x-ray absorptiometry and serum leptin levels by radioimmunoassay in 44 healthy postmenopausal women randomized to receive either no treatment (n = 22) or transdermal 17beta-estradiol (50 microg/day) in continuous regimen and nomegestrol (5 mg/day for 12 days/month) in a sequential regimen (n = 22). RESULTS: One year after the beginning of the study, in untreated women, total and trunk fat mass and percent fat were significantly increased, whereas trunk lean mass was significantly decreased. On the contrary, women treated with HT did not show any significant difference in body composition parameters. In untreated women, serum leptin levels were significantly increased at the end of the study in comparison with baseline values. Serum leptin levels at the other times evaluated were not significantly different from baseline values. In women treated with HT, serum leptin levels did not show significant changes throughout the study. CONCLUSIONS: Untreated postmenopausal women show an increase in total and percent fat mass and a centralization of fat distribution. Serum leptin levels parallel this increase, resulting in significantly higher levels 1 year after the study. Women treated with HT are protected against these changes. This may represent a protective mechanism against cardiovascular diseases.

In this study menopausal symptoms, endometrial histology, uterine bleeding pattern, plasma lipid concentrations, bone mineral loss, body weight and blood pressure have been evaluated in postmenopausal women who received continuous conjugated equine estrogens and medrogestone over a 1 year treatment period. By the third month of therapy we detected a significant (p0.01) improvement in postmenopausal symptomatology. At the 6th and 12th month, endometrial biopsy specimens revealed atrophic endometrium in all women. Uterine bleeding episodes were observed especially during the first months of treatment. Amenorrhoea was found in all patients only after 8 months of therapy. By the 6th month of therapy, we observed a significant (p0.01) decrease of plasma cholesterol and low-density lipoprotein cholesterol levels. Instead, plasma high-density lipoprotein and triglycerides concentrations didn't show significant variation from baseline values. No significant changes in bone mineral density could be detected after 12 months of treatment. Body weight and blood pressure were not significantly altered from baseline. This study suggests that continuous conjugated equine estrogens plus medrogestone treatment appears to be an interesting and safe manner to administer postmenopausal hormone replacement therapy. This regimen could represent a good alternative to sequential estroprogestin therapy in women who do not tolerate withdrawal bleeding.

Objective To investigate the effects of postmenopausal hypoestrogenism on the content of autonomic vasoconstrictor (neuropeptide Y) and vasodilator neuropeptides (vasoactive intestinal peptide and substance P) at the arterial level. Design Prospective, clinical study. Setting Department of Gynecology and Obstetrics and Pathophysiology of Human Reproduction, University of Naples “Federico II,” Naples, Italy. Patient(s) Twenty premenopausal women and 20 postmenopausal women, matched for age and parity. Intervention(s) All patients underwent abdominal hysterectomy with bilateral oophorectomy for benign conditions. During surgery, a sample of uterine artery was obtained. The presence of E2, estrogen receptor α (ERα), neuropeptide Y (NPY), vasoactive intestinal peptide (VIP), substance P (SP), and S100 (a generic neuronal marker) was evaluated by means of immunohistochemistry and Western-blot analysis. Main Outcome Measure(s) Mean arterial content of E2, ERα, VIP, NPY, and SP. Result(s) Both immunohistochemical and Western-blot analysis showed that after menopause, the reduction in E2 and ERα in the uterine artery wall is associated with a decrease in vasodilator neuropeptides and an increase in vasoconstrictor NPY. A similar immunopositivity for S100 was observed in pre- and postmenopausal samples, which demonstrated similar total neuronal fiber contents. Conclusion(s) Postmenopausal hypoestrogenism seems to increase arterial vascular tone through a reduction of vasodilator neuropeptides and an increase in vasoconstrictor peptides in the arterial-wall termination of the autonomous system. These changes in neuropeptide content in the arterial walls might represent a new mechanism underlying the negative effects of menopause on the cardiovascular system.

Objective: To compare body composition and serum leptin levels in untreated postmenopausal women and postmenopausal women treated with tibolone or raloxifene. Design: This was a prospective, randomized, controlled study. Sixty-eight postmenopausal women were randomized to receive either no treatment (group A; n = 21), tibolone 2.5 mg/day (group B; n = 23), or raloxifene 60 mg/day (group C; n = 24). All women underwent height, weight, and body mass index evaluation and dual-energy x-ray absorptiometry determination of body composition at the beginning of the study and after 12 months. Serum leptin levels were determined at the beginning of the study and after 1, 3, 6, and 12 months in all groups. Results: Women in group A showed no significant changes in both fat and lean mass of arms and legs, whereas a significant increase in trunk fat mass, total fat mass, total percentage of body fat, and trunk percentage of fat was detected 1 year after the beginning of the study. After 12 months, the total percentage of fat mass was significantly higher in group A compared with group B, and the trunk percentage of fat mass was significantly higher in group A compared with the other groups. In subjects in groups B and C, after 1 year, fat mass, both total and at all areas evaluated, did not show any significant change compared with baseline values. In subjects in group B, total lean and lean mass of the trunk and legs increased significantly at the end of the study, whereas no significant changes were observed in lean mass total and at all areas evaluated in subjects in group C. After 12 months, total lean mass and lean mass of the legs were significantly higher in group B compared with the other groups. In group A, serum leptin levels were significantly increased at the end of the study compared with baseline values. Leptin concentrations were significantly higher in group A compared with groups B and C after 6 and 12 months. No significant change in serum leptin levels in subjects in groups B and C was detected throughout the study. Serum leptin levels showed a positive, significant correlation with all body composition parameters and body mass index in all groups at the beginning and at the end of the study. Conclusions: The present study confirms that postmenopausal hypoestrogenism leads to increased fat content and serum leptin levels. Raloxifene and tibolone seem to prevent postmenopausal body composition changes without significant modifications of serum leptin levels.

Objective : To evaluate the effects on monthly bleeding of four different progestogens administered in association with transdermal estradiol in a continuous sequential estrogen-progestin therapy (CS-EPT). Design : This prospective, open, randomized, clinical trial included 100 healthy postmenopausal women. Patients were randomized into four treatment groups, each consisting of 25 women. Treatment consisted of 50 mug/day transdermal 17beta-estradiol for all women combined to receive four different progestogens (group A: medroxyprogesterone acetate, 10 mg/day; group B: nomegestrol acetate, 5 mg/day; group C: dydrogesterone, 10 mg/day; group D: micronized progesterone, 200 mg/day) per os from the 14th to 25th day of each 28-day cycle. The duration of treatment was 12 cycles. Patients were asked to record in a daily diary the occurrence of any vaginal bleeding, the days of application of each patch, the days of assumption of the different progestogens, and the exact moment of bleeding onset. Results : A total of 937 cycles could be evaluated. In 690 cycles (73.6%), regular progestogen-related bleeding was reported. Among the other cycles, we observed 73 episodes of amenorrhea (7.8%, each one lasting one cycle), 78 episodes of irregular bleeding (8.3%), and 96 episodes of spotting (10.2%). Patients receiving nomegestrol acetate had a significantly higher incidence of regular progestogen-associated bleeding in comparison with those receiving medroxyprogesterone acetate or natural progesterone, and patients receiving dydrogesterone had a significantly higher incidence of regular progestogen-associated bleeding in comparison with those receiving natural progesterone. Conclusion : Our data suggest that CS-EPT generally leads to regular withdrawal bleeding in women without uterine pathology. Micronized progesterone seems to induce more irregular bleeding episodes.

This study shows the effect of a 1 year treatment with an estradiol valerate/dienogest pill in 36 women suffering from polycystic ovaries and mild or moderate acne. At beginning of the study, 24 patients (66.7%) had grade 1-2 (mild) acne and 12 patients (33.3%) had grade 3 (moderate) acne. After 12 cycles of therapy, we found an improvement of acne in 19 (52.8%) patients and a worsening of acne in 3 (8.4%) patients. The percentage of patients recovered was statistically significant (p 0.01). SHBG levels were significantly higher after 6 and 12 months of therapy (p 0.001), while total testosterone levels were lower in all patients at 6 and 12 months although this trend did not reach statistical significance. In conclusion, the present study suggests that the E2V/DNG pill could exert a positive influence on acne and hyperandrogenism. Since this is an observational study on a very limited population number, additional randomized controlled studies on larger populations are needed also to determine the effects of this contraceptive over longer periods of use.

To evaluate the effect of a protocol of local anesthesia and epinephrine associated with sedo-analgesia on post-TVT-O pain in comparison with infiltration of saline and epinephrine.Forty-two patients undergoing TVT-O were randomized into two groups to receive periurethral infiltration with epinephrine only (group A, n = 21) or with epinephrine plus 1 % lidocaine hydrochloride (group B, n = 21). Post-operative pain was assessed using a visual analog scale (VAS) from 0 (absence of pain) to 10 (maximum pain possible), 1, 6, 12 and 24 h after the procedure. The total amount of analgesia was recorded and the proportion of women reporting a pain VAS score ≥4, 1 h after the procedure was calculated. ANOVA for repeated measures and Bonferroni correction, the Student's t test for independent samples, the Mann-Whitney U test, the Fisher exact test, or the χ (2) test for parametric was used.Pain level was significantly lower in group B 1 (p = 0.01) and 6 h (p = 0.05) after surgery, but not 12 and 24 h after the procedure. No significant difference was observed in the proportion of women requesting analgesia and in the total dosage of analgesics between the two groups. A significant higher proportion of women in group A reported a pain VAS score higher than four 1 h after surgery in comparison with patients in group B.This randomized study seems to indicate that systematic infiltration before TVT-O positioning with local anesthetic may reduce immediate post-operative pain.

This is an observational study on 102 women aged 25-45 years to evaluate if the E2V/DNG pill has any impact on quality of life (QoL) and sexual function (FSF). Thirty-nine women were younger than 35 years (group A), and 63 women were 35 years old or older (group B). At baseline and after 6 months, patients received the Italian validated version of the Short Form-36 questionnaire and the Italian validated version of the Female Sexual Function Index questionnaire. Group A showed an overall higher perception in all QoL scores at baseline and after 6-months (p 0.05). E2V/DNG treatment did not exert any significant effect on QoL perception in group A apart from an increase in the GH domain (general health). In group B we observed a significant improvement both in GH and in VT (vitality) scores. We found a significant reduction in "lubrication" after 6 months both in group A and B (p 0.01) and a significant improvement in "satisfaction" and "pain" scores in group A and in "desire", "satisfaction" and "total" score in group B (p 0.01). The E2V/DNG pill is associated with a significant improvement of GH and VT and with an improvement in FSF with no difference between age groups.

The aim of this study was to evaluate the effectiveness of lactational amenorrhoea and to determine the relationship between extended breastfeeding and the return of fertility. Breastfeeding pattern, basal body temperature, cervical mucus, salivary ferning, vaginal blood discharge, frequency of sexual intercourse, and the presence of ovulation in the first cycle after the resumption of menses with ultrasonography were evaluated in 40 women. All subjects completed the study with only one case of incomplete breastfeeding. No pregnancies were observed. The mean number of feeding sessions and mean interval between sessions decreased significantly (p0.01) during the first six months postpartum (7.5 +/- 1.3 after 60 days postpartum vs. 5.7 +/- 2.1 after 180 days, and 3.6 +/- 0.8 vs. 5.1 +/- 0.9, respectively). Eight women (20%) menstruated before weaning, but none had an adequate thermal shift, while 32 (80%) had their first vaginal bleeding after weaning with 12 (37.5%) registering an adequate thermal shift. Both basal body temperature and salivary ferning proved to be suggestive of ovarian activity, while mucus characteristics were not reliable in identifying fertile periods. Our study showed that breastfeeding associated with lactational amenorrhoea proved to be a good method of postpartum fertility control. Since the importance of supplementation is still debated, it is recommended that a "complete" breastfeeding program be used.

Recent years have witnessed important developments in natural family planning (NFP), which is based on the observation of fertile and infertile periods of the menstrual cycle, so that the couple is able to know when sexual intercourse may lead to a pregnancy. A review of the main studies regarding the effectiveness of NFP showed a decrease in the Pearl Index and life table values from the early 1980s to date, indicating that progress both in the teaching and in the application of these contraception, methods has been achieved. The main cause of lack of success seems to be the misapplication of NFP rules, whereas the errors due to the method itself are few. Furthermore, it seems that the symptothermal method might give better results than the ovulation method, even though no comparative study has been carried out, and that the first studies on the lactational amenorrhea method show encouraging results. Finally, it seems that NFP is best suited for 'spacers' of pregnancies, rather than for 'limiters'. Indeed, the former are more likely to show good compliance, since the sexual abstinence periods are limited and an unwanted pregnancy is not regarded as a completely negative event.

The aim of the study was to determine the impact of etonogestrel (ENG)-implant used for contraceptive purpose on Quality of life (QoL) and on sexual function (FSF) of healthy Italian women. The Female Sexual Function Index (FSFI) questionnaire and the Short Form-36 (SF-36) validated questionnaire were administered at baseline, 3 and 6 months after insertion of Nexplanon. The implant seems to have a positive impact on QoL after the first three months of therapy. Users showed an improved general health status and physical role status. The implant did not show negative effects on libido and on sexual function. In the first three months of treatment, users experienced a temporary reduction of vitality, mental health, social functioning and emotional role functioning, which seem to disappear after six months of therapy.

To compare the efficacy of a personal dietary intervention on gestational weight gain control with a general intervention promoting healthy eating.Prospective, controlled study including 154 low-risk pregnant women randomly allocated to two groups: 77 receiving a personalized diet plan and a close follow-up by a dietician (intervention group), 77 receiving standard dietary care by means of a brochure on healthy eating during pregnancy (control group). Pre-pregnancy weight, gestational age, height, weight and BMI at baseline, weight at term, gestational age at delivery and newborn weight were recorded for all participants. The primary end-point was the difference in body weight between baseline and term. Secondary end-points were the difference in body weight between pre-pregnancy and term and in newborn weights.Maternal weight gain at term was significantly lower both as compared to pre-pregnancy weight (8.2 ± 4.0 vs. 13.4 ± 4.2 kg; p 0.001) and to weight at baseline (7.7 ± 3.8 vs. 13.7 ± 4.3 kg; p 0.001) in the intervention group as compared to controls. A positive, significant correlation between the delta weight between baseline and term and newborn weight was observed in both groups, but stronger in patients from the intervention group (intervention group R = 0.76, p 0.001; control group R = 0.35, p = 0.01).This study suggests that a personalized nutritional intervention, in which the dietician plays an active role within the obstetric team, may represent a successful approach in limiting weight gain in pregnant women.

To evaluate the impact of a more limited paraurethral dissection, avoidance of perforating the obturator membrane with scissors or guide, and a more medial trajectory of the trocar in positioning the TVT-O device on stress urinary incontinence cure rates.One hundred and ten patients were recruited for this randomized, single blind, multicenter, non-inferiority study, with a 1:1 ratio to undergo the traditional (n=55) or the modified (n=55) technique. Preoperatively, patients underwent POP-Q staging, Q-tip test, challenge stress test and urodynamics, and completed the I-QoL, PISQ-12, and PGI-S questionnaires. During the post-operative period, patients attributed a pain VAS score 1, 3, 6, 12 and 24h after the procedure and were followed up at 12 months, undergoing the same baseline evaluations. The primary outcome was the cure rate (absence of urine leaks at the challenge stress test or urodynamic testing) one year after the procedure. The primary outcome was evaluated using a non-inferiority test.No differences were observed in cure rates (traditional technique 92.3% vs. modified technique 88.8% and non-inferiority P0.05) and in questionnaire scores between the two groups. Post-operative pain was significantly lower in the modified technique group at each time point assessed, with the exception of 12h post-operatively. No differences between the two groups were observed in the number of analgesic vials administered.The modified technique does not seem to reduce the efficacy of TVT-O, but induces a reduction of post-operative pain.

To evaluate the effects of a combined oral contraceptive (COC) containing dienogest/oestradiol valerate (DNG/E2V) on bone mineral density (BMD) and on serum and urinary bone turnover markers in young, healthy, fertile women.At baseline and after three and six months of intake of the aforementioned COC, serum and urinary calcium, osteocalcin, urinary pyridinoline (PYD), and deoxypyridinoline (D-PYD) of 30 women aged 21 to 34 years were measured. At baseline and after six months, lumbar bone mineral density was determined by dual-energy X-ray absorptiometry (DEXA).Urinary levels of PYD and D-PYD were significantly lower at three and six months in comparison with basal values (p0.05). Serum calcium levels showed an increasing trend, which reached statistical significance after six months in comparison with basal values while urinary levels of calcium did not vary significantly. Serum osteocalcin levels were somewhat, but not significantly, lower during pill use in comparison with basal values. After six months, spinal BMD values did not differ significantly from basal values.The DNG/E2V COC has no short-term adverse effect on bone turnover markers. No significant change in BMD was observed after six months of use of that pill.