Manuela Neri

Clinical effect of hormonal replacement therapy with estradiol associated with noretisterone or drospirenone. A prospective randomized placebo controlled study

Abstract The study was performed to compare the clinical effect of a hormone replacement therapy (HRT) with two different progestins. Postmenopausal women (PMW) with climacteric symptoms (CS) randomly received for 12 months orally, either placebo (n = 20), 1 mg estradiol (E) plus 0.5 mg noretisterone acetate (NETA; n = 40), or 2 mg drospirenone (DRSP; n = 40), a testosterone- and spironolactone-derived molecule, respectively. Weight (W) declined only during E/DRSP (p < 0.04 versus placebo). Fat mass (FM) decreased, similarly, during E/NETA and E/DRSP. Intracellular water (ICW) did not change, while extracellular water (ECW) decreased during E/DRSP (p < 0.0001) (p < 0.002 versus E/NETA). During E/NETA and E/DRSP, similar decreases were observed for insulin resistance (IR) by the homeostatic model assessment for IR (HOMA-IR) (p < 0.0001 versus placebo for both), systolic (p < 0.04 versus placebo for both) and diastolic (p < 0.002) blood pressure (BP). Lipids did not change. In comparison to placebo CS, by the Kupperman Index (KI), significantly declined (p < 0.0001) during E/NETA or E/DRSP. Menopause-specific Quality of Life (MENQoL) significantly declined versus placebo (p < 0.04) during both E/NETA and E/DRSP. In conclusion, differences between the two progestins are mainly limited to body composition (BC), where the addition of DRSP decreases ECW and body W (BW).

Long-acting reversible contraception (LARC) with the intrauterine system with levonorgestrel (6 mcg/d): observational study on the acceptability, quality of life, and sexuality in Italian women

Abstract This observational study was conducted in healthy premenopausal women, who presented themselves for contraception with an intrauterine system (IUS) releasing LNG (6 mcg/d) (Jaydess®, Bayer, Germany) at the outpatient Family Planning Clinics of the Departments of Obstetrics and Gynaecology of the Universities of Cagliari and Sassari (CA/SS), University-Hospitals of CA/SS (Italy). After a screening visit, 31 women without contraindications to Jaydess® were included in the study. No difficulty in Jaydess® insertion (Ji) was found in 87% of subjects, with pelvic pain (PP) (visual analogic scale, VAS:5.33 ± 2.54) reported by 27/31 subjects at the Ji. Pelvic pain was reported by 17/31 subjects on the first day (VAS: 3.07 ± 3.1), 16/31 subjects on the second day (VAS:2.37 ± 2.71), and 11/31 subjects on the third day (VAS:1.18 ± 2.02) from Ji, with a significant (p < .001) decrease in the intensity. The primary purposes of the study were to evaluate whether a 12-month-treatment (12-M-T) with Jaydess® interferes on either the quality of life (QoL) or sexuality. Jaydess® did not modify either QoL or sexuality in the 25 subjects who completed the 12-M-T. Throughout the 12-M-T, PP, or pregnancies were not found; the menstrual blood loss was significantly (p < .0001) reduced, and the intensity VAS of dysmenorrhea (#14 subjects) significantly (p < .001) improved.

The stimulation of the vaginal immune system with short-term administration of a vaginal gel containing fraction of Propionibacterium acnes, hyaluronic acid and polycarbophil is efficacious in vaginal infections dependent on disorders in the vaginal ecosystem

Abstract The vaginal immune system (VIS) is the first defense against antigens recognized as foreign. Substances capable of locally activating the VIS could be a valid strategy to treat vulvo-vaginal infections (VVI), caused by changes in the vaginal ecosystem, such as bacterial vaginosis (BV), vulvo-vaginal candidiasis (CA), and mixed vaginitis (MV). Bacterial lysates, obtained by crushing bacterial cultures, exert immuno-modulatory activities. The parietal fraction from Propionibacterium acnes is a patent of Depofarma (MoglianoVeneto, Italy). The preparation that associates such fraction to hyaluronic acid and polycarbophil is a registered trademark, commercially available in Italy as vaginal gel, Immunovag®. The study aimed to evaluate whether a 5-day-treatment with Immunovag® improves the symptoms and signs of VVI, in 60 women with Gardnerella vaginalis (GV), 154 with CA, 95 with MV, diagnosed with vulvar vaginal swab (VVS), and in 283 with BV, diagnosed with the Amsel criteria. At the end of the treatment (visit 2), the symptoms and signs of VVI disappeared in a significant number of subjects (χ2p < .02 vs pre-treatment) in all VVI groups, and their intensity was significantly (p < .0002) reduced in the subjects in which they were still present. Immunovag® represents a valid treatment of VVI induced by changes in the vaginal ecosystem.

Vilaprisan for treating uterine fibroids

ABSTRACT Introduction: The medical strategy to antagonize myoma size and related-symptoms is to reduce estrogen and progesterone activity on myomas. This can be obtained with the GnRH agonist (GnRHa) or with compounds that antagonize progesterone stimulatory activity on myomas. Selective progesterone receptor modulators (SPRMs) bind progesterone receptor (PR), leading to both agonist and antagonist effects. The result of SPRMs’s action is tissue-specific and it depends on the particular affinity and strength of each SPRM. Area covered: Ulipristal acetate (UPA) is the first SPRM registered for myoma treatment. UPA reduces heavy uterine bleeding within 7 days from the onset of treatment, whereas a longer time is required with GnRHa treatment. Vilaprisan is a novel powerful SPRM. Phase I and II studies give encouraging results on the efficacy of vilaprisan at different doses. Like other SPRMs, vilaprisan induces benign changes of endometrium (PR modulator-associated endometrial changes, PAECs). These disappear as treatment is discontinued. Unlike GnRHa treatment, neither UPA nor vilaprisan induce hypoestrogenism and associated symptoms. Phase III studies are ongoing to confirm efficacy and safety of vilaprisan in long-term treatment of symptomatic fibroids. Expert opinion: It is fundamental to underline the rapidity of action (only 3 days) in the control of myoma-related bleeding.

Body composition and psychological improvement in healthy premenopausal women assuming the oral contraceptive containing micronized estradiol (E2) and nomegestrol acetate (NOMAC)

Abstract This observational study was conducted in healthy premenopausal women, who presented themselves for contraceptive advice at the outpatient Family Planning Clinics of the Department of Obstetrics and Gynecology of the University of Cagliari, Hospital–University of Cagliari (Italy). After a screening period of three menstrual cycles, 48 women without contraindications to estroprogestin contraceptives (OCs) were included in the study. The primary purposes of the study were to evaluate whether a 12-month-treatment with the combined OC containing micronized estradiol (1.5 mg, E2) plus nomegestrol acetate (2.5 mg, NOMAC) (E2/NOMAC) interfere on anthropometric indices (AI), body composition (BC) and psychological status (PS). In subjects with dysmenorrhea (#36), its intensity was evaluated using the visuo analogic scale (VAS), both before and during the 12-month-treatment with E2/NOMAC. E2/NOMAC did not modify neither AI nor BC in the 40 subjects who concluded the study. The PS and the VAS of dysmenorrhea were significantly (p < 0.0001) improved from the first cycle of treatment and throughout the E2/NOMAC treatment in comparison with basal values. The study suggests that E2/NOMAC is devoid of negative effects on AI and BC, with additional benefits on PS and dysmenorrhea.

Effect of Estradiol valerate plus dienogest on body composition of healthy women in the menopausal transition: a prospective one-year evaluation.

Abstract In the menopausal transition (MT), combined oral contraceptive (COC) should be chosen accordingly to its neutrality on liver metabolism and to its ability to counter the increase of fat mass (FM) that occurs in this reproductive period of life. This prospective multi-centric observational study was conducted on 36 women in their MT at the Universities of Cagliari, Modena and Naples. The body weight (BW), the Body Mass Index (BMI), the waist to hip ratio (WHR), the measurement of body composition (BC) with the Multi-frequency Bioelectrical Impedance (MF-BIA) were performed before, at the 6th and at the 12th month of the study in which a group of women (control group; N.18) did not assume COC, whereas the other 18 women assumed the four-phasic COC containing estradiol valerate (EV) associated with dienogest (EV/DNG group). In comparison to controls in the EV/DNG group, a significant decrease (p < 0.05) of BW (58.8 ± 7.6 to 57.3 ± 7.0), BMI (24.1 ± 2.7 to 23.5 ± 2.8), WHR (0.82 ± 0.052 to 0.79 ± 0.048) and FM (17.7 ± 5.4 to 16.4 ± 5.6) was observed. In controls, FM significantly increased (17.0 ± 11 to 17.7 ± 2.7; p < 0.05). In conclusion, these results suggest that the anti-androgenic and progestinic activities of DNG associated with a weak estrogenic activity of EV, is a contraceptive method capable of counteracting the negative changes of BC occurring in the MT.

Risk management in obstetrics: how to reduce the risk?

In this paper the authors examined the most important factors that in the pre-conception period can interfere in the evolution of pregnancy. They also reported a method that since the first trimester of pregnancy is able to identify women at higher risk of developing preeclampsia. Proceedings of the 11 th International Workshop on Neonatology and Satellite Meetings · Cagliari (Italy) · October 26 th -31 st , 2015 · From the womb to the adult Guest Editors: Vassilios Fanos (Cagliari, Italy), Michele Mussap (Genoa, Italy), Antonio Del Vecchio (Bari, Italy), Bo Sun (Shanghai, China), Dorret I. Boomsma (Amsterdam, the Netherlands), Gavino Faa (Cagliari, Italy), Antonio Giordano (Philadelphia, USA)