The Reproducibility of Ultrasonographic Findings of Rectosigmoid Endometriosis Among Examiners With Different Level of Expertise.

OBJECTIVE: To analyze the reproducibility of ultrasonographic (US) findings of rectosigmoid endometriosis among examiners with different level of expertise using stored three-dimensional (3D) volumes of the posterior compartment of the pelvis as a part of SANABA (Sardinia-Navarra-Barcelona) collaborative study. MATERIALS AND METHODS: Six examiners in 3 academic Department of Obstetrics and Gynecology, with different levels of experience and blinded to each other, evaluated 60 stored 3D volumes from the posterior compartment of the pelvis and looked for the presence or absence of features of rectosigmoid endometriotic lesions defined as an irregular hypoechoic nodule with or without hypoechoic foci at the level of the muscularis propria of the anterior wall rectum sigma. Multiplanar view and virtual navigation were used. All examiners had to assess the 3D volume of posterior compartment of the pelvis and classify it as present or absent disease. To analyze intra-observer and the inter-observer agreements, each examiner performed the assessment twice with a 2-week interval between the first and second assessments. Reproducibility was assessed by calculating the weighted Kappa index. RESULTS: Intra-observer reproducibility was moderate to very good for all observers (Kappa index ranging from 0.49 to 0.96) associated with a good diagnostic accuracy of each reader. Inter-observer reproducibility was fair to very good (Kappa index range: 0.21-0.87). CONCLUSIONS: The typical US sign of rectosigmoid endometriosis is reasonably recognizable to observers with different level of expertise when assessed in stored 3D volumes.

Repeated two cycles of ulipristal acetate treatment improve the quality of life in premenopausal women with heavy menstrual bleeding dependent on uterine myomas, without impairment of bone health.

This observational study was conducted in premenopausal women who presented themselves at the Obstetrics and Gynecology Department of the University Hospital of Cagliari (Italy), for heavy menstrual bleeding (HMB) dependent on uterine myomas. After a screening visit, 19 women without contraindications to ulipristal acetate (UPA) treatment, were included in the study that envisaged 12 months of observation in which each subject was asked to assume UPA (tablet of 5 mg, ESMYA®, one tablet a day for 3 months: first cycle) two menstrual cycles of interruption and a second ESMYA® cycle, followed by 3 months of observation (third follow-up month, visit 4). The significant decrease of myoma volume, diagnosed after the first ESMYA® cycle, persisted until the visit 4. The HMB significantly decreased during the ESMYA® treatment and persisted until visit 4. The quality of life (QoL), evaluated with the questionnaire SF-36, significantly improved during the study. The values of estradiol (E2), biochemical parameters of bone metabolism, as well as those of lumbar and hip bone mineral density, did not change during the study in comparison with basal levels. The efficacy of two repeated ESMYA® cycles to treat uterine myomas and their related symptoms improves the QoL without interfering with bone health.

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.

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.

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.

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.

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

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.

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.

Observational study on the efficacy of the supplementation with a preparation with several minerals and vitamins in improving mood and behaviour of healthy puerperal women.

We investigated whether a formulation containing vitamins and minerals (vit&min) could improve the worsening of mood changes occurring after delivery ("a.d."). The study was performed in 552 healthy non-anaemic puerperal women ("p.w") without risk factors for puerperal depression ("p.d"). They were at their first full-term pregnancy, and spontaneously delivered healthy newborns. The Edinburgh Depression Postnatal scale (EPDS) evaluates the psychological status of "p.w". EPDS was administered the 3rd (visit 1), 15th (visit 2) and 30th (visit 3) day "a.d.". An EPDS >12 indicates a major susceptibility to "p.d". At the same time intervals, haemoglobin, iron and ferritin (haematological parameters) levels were evaluated. After visit 1, the subjects were randomized to vit&min treatment (group A; N.274) or to calcium/vitamin D3 treatment (group B; N.278). In both groups haematological parameters significantly increased without differences between the groups. EPDS score improved in both groups, but in the group A, the EPDS decrease was significantly larger (p < 0.05) in comparison to the group B. This effect is mainly evident in subjects with a basal EPDS ≥ 12. An early examination of psychological condition could select "p.w." with a high susceptibility to neuronal changes occurring postpartum. Vit&min favourably modulates brain functions antagonizing the evolution to "p.d".

MRI and "tenderness guided" transvaginal ultrasonography in the diagnosis of recto-sigmoid endometriosis.

PURPOSE: To compare the diagnostic accuracy of MRI and "tenderness-guided" transvaginal ultrasonography (tg-TVUS) in the identification of recto-sigmoid endometriosis. MATERIALS AND METHODS: Institutional Review Board approval for this study was obtained, and written informed consent was given by all patients. This study is compliant with the STARD (Standards for Reporting of Diagnostic Accuracy) method. Fifty-nine patients (mean age, 33 years; range, 21-44 years) with clinical suspicion of deep pelvic endometriosis were prospectively enrolled. They underwent tg-TVUS and MRI before surgery. The characteristics of the MRI signal were analyzed. Mapping of recto-sigmoid endometriosis was performed and tg-TVUS and MR imaging results were compared with surgical and pathological findings. Sensitivity, specificity, and the positive and negative likelihood ratio (LR+ and LR-) were calculated. Inter-technique concordance was assessed using the Cohen statistic, and receiver operating characteristic (ROC) curves were obtained. Logistic regression analysis was performed. RESULTS: The prevalence of recto-sigmoid endometriosis was 51%. The specificity, sensitivity, and LR+ and LR- were 90%, 73%, 7.089 and 0.297, respectively, for MRI and 86%, 73%, 5.317 and 0.309, respectively, for tg-TVUS. The presence of a high T1 signal spot was an excellent specific finding (100%) but was associated with a low sensitivity (30%). Inter-technique concordance using the Cohen statistic indicated a kappa value of 0.658 (± 0.098 SD). According to the logistic regression equation obtained, the use of both tg-TVUS and MRI allows optimal diagnostic performance. CONCLUSION: MRI and tg-TVUS show similar results in the identification of recto-sigmoid endometriosis. The Cohen kappa value suggests that these methods may have complementary roles in the identification of recto-sigmoid endometriosis, depending on the site affected.

Advances in Imaging for Assessing Pelvic Endometriosis.

In recent years, due to the development of standardized diagnostic protocols associated with an improvement in the associated technology, the diagnosis of pelvic endometriosis using imaging is becoming a reality. In particular, transvaginal ultrasound and magnetic resonance are today the two imaging techniques that can accurately identify the majority of the phenotypes of endometriosis. This review focuses not only on these most common imaging modalities but also on some additional radiological techniques that were proposed for rectosigmoid colon endometriosis, such as double-contrast barium enema, rectal endoscopic ultrasonography, multidetector computed tomography enema, computed tomography colonography and positron emission tomography-computed tomography with 16α-[18F]fluoro-17ß-estradiol.

Three-dimensional sonographic characteristics of deep endometriosis.

OBJECTIVE: The purpose of this presentation is to investigate the potential role of 3-dimensional (3D) sonography in the assessment of deep endometriosis. METHODS: Cases of deep endometriosis are presented to illustrate the spectrum of appearances obtained with 3D sonography. In addition, we evaluate the possible role of other functions included in 3D equipment, such as the niche mode and tomographic ultrasound imaging (TUI). RESULTS: Three-dimensional image rendering could allow a good analysis of the endometriotic nodule; in fact, in all presented cases, this reconstruction seems to clearly show the irregular shapes and borders of the lesions. This technique allows unrestricted access to an infinite number of viewing planes, which can be very useful for correctly locating lesions within the pelvis and evaluating the relationship with other organs. The stored 3D volumes can be reassessed and compared by the same or different examiners over time. This characteristic may be relevant for monitoring the effect of medical therapies over time. In the niche mode, sonographic imaging is represented as a "cut-open" view of the internal aspect of the nodule and its surrounding tissue. This additional function, which is associated with TUI, could be particularly useful for evaluation of the extension of a nodule in the rectovaginal septum, the depth of infiltration, and the relationship with the rectosigmoid junction or ureter. CONCLUSIONS: In the near future, 3D sonography in deep infiltrating endometriosis could be an interesting mode of research with positive effects in everyday clinical practice.

Clinical Utility Of Elagolix As An Oral Treatment For Women With Uterine Fibroids: A Short Report On The Emerging Efficacy Data.

Uterine fibroids (UFs) are the most common gynaecological benign disease. Even though often asymptomatic, UFs can worsen women's health and their quality of life, causing heavy bleeding and anaemia, pelvic discomfort and reduced fertility. Surgical treatment of UFs could be limited by its invasiveness and the desire to preserve fertility. Thus, effective medical therapies for the management of this condition are needed. Common drugs used to control bleeding, such us hormonal contraceptive or levonorgestrel-releasing intrauterine system, have no effect on fibroids volume. Among other more efficient treatments, the gonadotropin-releasing hormone (GnRH) agonist or the selective progesterone-receptor modulators have a non-neutral safety profile; thus, they are used for limited periods or for cyclic treatments. Elagolix is a potent, orally bioavailable, non-peptide GnRH antagonist that acts by a competitive block of the GnRH receptor. The biological effect is a dose-dependent inhibition of gonadal axis, without a total suppression of estradiol concentrations. For this reason, even though comparative studies between elagolix and GnRH agonists have not been performed, elagolix has been associated with a better profile of adverse events. Recently, elagolix received US FDA approval for the treatment of moderate to severe pain caused by endometriosis. Several clinical trials assessed the efficacy of elagolix for the treatment of heavy bleeding caused by UFs and the definitive results of Phase III studies are expected. Available data on elagolix and UFs showed that the drug, with or without low-dose hormone add-back therapy, is able to significantly reduce menstrual blood loss, lead to amenorrhea and improve haemoglobin concentrations in the majority of participants in comparison with placebo. The safety and tolerability profile appeared generally acceptable. The concomitant use of add-back therapy can prevent bone loss due to the hypoestrogenic effect and can improve safety during elagolix treatment.

Vilaprisan for treating uterine fibroids.

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.

[Bacterial vaginosis: efficacy of a local treatment with a gel containing a fraction derived from propinibacterium acnes]. / Vaginosi batterica: efficacia di un trattamento locale con un gel vaginale a base di una frazione batterica derivata da Propionibacterium acnes.

BACKGROUND: Bacterial vaginosis (BV) is favored by a decreased activity of vaginal immune system. The fraction derived from Propionibacterium acnes is known to activate the immune system and is used parenterally to treat respiratory and urinary infections. The employ of a fraction derived from Propionibacterium acnes locally, in the context of the vaginal immune system, is made possible by a vaginal gel in which this fraction is associated with hyaluronic acid, well-known for its moisturizing activity, and polycarbophil, capable of miming the function of cervical mucus. The aim of the study was to evaluate whether this preparation is efficacy in the treatment of vulvovaginal symptoms associated to BV. METHODS: After the diagnosis of BV and the evaluation of a Visual Analogic Score >6 for vulvovaginal itch and burning, 33 women participated in this study on a voluntary basis. They were treated with a vaginal gel (Immunovag®, Depofarma, Italy) for 5 days, with one vulvovaginal application a day. RESULTS: The day following the last application, the subjects reported a significant reduction of vulvovaginal symptoms and a significant reduction of vulvovaginal erythema and leucorrhea. In the vaginal swab performed before the treatment, anaerobic microorganisms were positive in 82% and negative in 18% of cases; when tested the day following the end of treatment, it was positive in 25% and negative in 75% of subjects. Symptom reduction rates did not differ between the groups with positive or negative vaginal swab. The results obtained in the subjects treated with Immunovag® were similar to those obtained in a group of women with BV treated with clindamycin cream (one daily vulvovaginal application of 100 mg, for 5 days). CONCLUSIONS: The activation of the vaginal immune system induced by Immunovag® can antagonize the symptoms of BV and counteract the growth of vaginal anaerobic microorganisms.

Efficacy and safety of oral and transdermal hormonal replacement treatment containing levonorgestrel.

OBJECTIVES: The oral combined formulation of levonorgestrel with estradiol valerate (LNG+EV) has demonstrated to be effective on some postmenopausal symptoms. The availability of a transdermal HRT in sequential formulation with 17-beta-estradiol plus levonorgestrel (TSE2+TSLNG) induced us to do this control-study with the aim to evaluate the efficacy and safety of both oral and transdermal treatments. METHODS: At baseline, the psychological symptoms with the psychometric scale SCL-90, the bone resorption with the measurement of the urinary levels of pyridinoline and dexoxypirydinoline, and the insulin and lipid metabolism were assessed in 30 postmenopausal women (PMW) and in 18 premenopausal women. Then, the PMW women were randomly divided in three groups: group A (N=10) assumed EV+LNG, group B (N=10) did not assume any treatment, group C (N=10) was treated with TSE2+TSLNG. The length of the study was 12 months. The aforementioned assessments were repeated at different time-intervals up to the end of the study. RESULTS: The total score of SCL-90, the bone resorption, the levels of LDL-cholesterol, total-cholesterol and the parameters of insulin metabolism were higher in PMW than in premenopausal women. During the study, the SCL-90, the bone resorption, total-cholesterol, and LDL-cholesterol levels significantly decreased only in the groups A and C. By contrast, in the group B bone resorption significantly increased at the 12th month. During the treatments, insulin metabolism did not change in the groups A and B. In the group C the secretion of C-peptide and the C-peptide:insulin ratio after OGTT were significantly higher at the 12th month than before treatment. In all groups the endometrium thickness did not change during the study. CONCLUSION: A 12-month of either oral or transdermal HRT containing levonorgestrel seems to exert beneficial effects on the main postmenopausal symptoms without negative interferences on the endometrium.

Reproducibility of two different methods for performing mean gray value evaluation of cyst content in endometriomas using VOCAL.

OBJECTIVE: To compare two different methods (manual sampling of the entire cyst and semi-automated spherical sampling from the central part of the cyst) for calculating the mean gray value (MGV) from the cystic content in endometriomas using virtual organ computer-aided analysis (VOCAL). METHODS: Forty-one volumes from histologically confirmed endometriomas were retrieved from our database and the volumes were analyzed to compare the MGVs obtained via the two modalities. In addition, to evaluate the reproducibility in a sample of 20 volumes, two different observers calculated the MGV from cyst content using VOCAL software. For each method, each examiner analyzed the volumes twice, 3 weeks apart, for assessment of intra-observer agreement. First, manual sampling of the internal contour of all the cysts was performed, and 1 week later semi-automated 2-cm sphere sampling from the central part of the cyst was carried out. In addition, the observers recorded the time spent performing each analysis. Inter- and intra-observer reproducibility was evaluated for each method using intra-class correlation coefficients (ICC). RESULTS: There was no difference in the mean MGV between manual sampling (22.211 ± 7.541) and the semi-automated modality of sampling (23.840 ± 8.621, p = 0.439). The correlation between manual and semi-automated sampling measurement was high (r = 0.92). According to the ICCs, there was no significant difference in interobserver reliability between manual sampling (0.931; 95 % CI, 0.824-0.973) and the semi-automated modality of sampling (0.924; 95 % CI, 0.809-0.970). Intra-observer reproducibility for both examiners was good (ICC > 0.94). Semi-automated measurements were obtained faster than those obtained by manual evaluation (p = 0.0001 for observer 1 and p = 0.083 for observer 2). CONCLUSIONS: Both methods seem to be reliable, but the semi-automated method using the sphere should be preferred because it is a less time-consuming procedure.

Pharmacokinetic evaluation of ulipristal acetate for uterine leiomyoma treatment.

INTRODUCTION: Progesterone (P), and its receptors (PRs), play a key role in uterine leiomyoma growth. Selective progesterone receptor modulators exert mixed antagonist and agonist effects on the PRs. Mifepristone, a PR-antagonist, reduces leiomyoma volume and related symptoms. Ulipristal acetate (UPA) exerts a potent antiprogestin activity, with less antiglucocorticoid activity compared to mifepristone. This property provides potential advantages for long-term use. AREAS COVERED: This paper focuses on the effect of UPA on leiomyoma's growth and related symptoms in women. The authors also evaluate UPA's efficacy in reducing leiomyoma's size and menorrhagia in Phase II/III trials. EXPERT OPINION: In the authors' opinion, UPA (5 mg/day) over 3 months can be used to plan the surgery in women with symptomatic leiomyomas. The tolerability and the safety of treatment over a period longer than 3 months have to be evaluated. The results of the follow-up treatment suggest that further studies could successfully evaluate the efficacy and the tolerability of intermittent 3-month courses of treatment.

Learning curve in the detection of ovarian and deep endometriosis by using Magnetic Resonance: comparison with surgical results.

PURPOSE: Determining if Magnetic Resonance Imaging (MRI) accuracy in diagnosing endometriosis is related to radiologist's expertise. METHODS AND MATERIALS: Written informed consent was obtained from all patients. This study is compliant to STARD method. Thirty patients (mean age 34; range 21-45 years) who had undergone MRI study for suspected endometriosis underwent surgery were retrospectively evaluated. MRI at 1.5T was performed with SE and TSE sequences, T1 and T2-weighted with and without fat suppression. Four localizations were analyzed: ovary, uterosacral ligaments (USL), vaginal fornix and Rectum\Sigma\Douglas (R.S.D.). One radiologist evaluated each dataset; sensitivity, specificity, PPV and NPV, accuracy, LR+ and LR- were calculated according to the surgical results (first analysis). Dataset were then re-analyzed 12 months (second analysis) and 24 months (third analysis) later. McNemar test was applied to determine differences between the three analysis. RESULTS: Sensitivity, specificity and accuracy for the ovary at the first analysis were 88.9%, 87% and 88%, at the second 92.6%, 87% and 90% whereas at the third 92.6%, 91.3% and 92%. Sensitivity, specificity and accuracy for the USLs at the first analysis were 62.5%, 76.9% and 70%, at the second 72%, 80.8% and 76% whereas at the third 80%, 84.6% and 82%. Sensitivity, specificity and accuracy for the vaginal fornix at the first analysis were 63.2%, 64.5% and 64%, at the second 73.7%, 77.4% and 76% whereas at the third 73.7%, 83.9% and 80%. Sensitivity, specificity and accuracy for the R.S.D. at the first analysis were 39.1%, 81.5% and 62%, at the second 62.5%, 85.2% and 76% whereas at the third 73.9%, 88.9% and 82%. McNemar test indicated a significant statistical difference in sensitivity in detecting nodules of endometriosis in R.S.D. between first and third analysis (p=0.0215). The mean review time decreased (p=0.0001). CONCLUSIONS: Accuracy of MRI in diagnosing endometriosis increased with radiologist's expertise and the improvement was statistically significant in determining RSD involvement.

Endocrinological, metabolic and clinical features of treatment with oral contraceptive formulation containing ethinylestradiol plus chlormadinone acetate in nonobese women with polycystic ovary syndrome.

BACKGROUND: Chlormadinone acetate (CMA) is a progestin compound similar to progesterone, with antiandrogenic properties. In healthy eumenorrheic women, it was demonstrated that the monophasic estroprogestin formulation containing CMA (2 mg) plus ethinyl estradiol (EE) (30 mcg) (EE30+CMA) is efficacious both in reducing hyperandrogenic symptoms, fat mass and in improving lipoprotein panel, without changes in insulin-glucose metabolism. These metabolic properties are important for women affected by polycystic ovary syndrome (PCOS) in whom there is a predisposition to insulin resistance. STUDY DESIGN: We studied whether in young nonobese women with PCOS (15 subjects, EE30+CMA-PCOS group) a six-cycle treatment with EE30+CMA can reduce androgen levels, androgen bioavailability and the score of hirsutism and acne, and modify glucose-insulin metabolism evaluated by the oral glucose tolerance test and the body composition evaluated by bio-impedenziometry. These parameters were evaluated before (first visit) and during the sixth cycle of EE30+CMA (second visit). All the results were compared with those of a matched-age-group of nonobese PCOS women (15 subjects, no OC-PCOS group) evaluated before (first visit) and after six menstrual cycles in which they did not use any drug or oral contraceptive (second visit). RESULTS: In the EE30+CMA-PCOS group women, androgen levels and bioavailability, hirsutism and acne score were significantly lower at the second than at the first visit, whereas they did not change in no OC-PCOS group. At the second visit, in both groups, glucose-insulin metabolism and body composition parameters were not affected. CONCLUSIONS: A six-cycle treatment with EE30+CMA is efficacious in nonobese PCOS women to improve hyperandrogenic symptoms, without negative interferences both on body composition and on insulin-glucose metabolism.

Evidence that in healthy young women, a six-cycle treatment with oral contraceptive containing 30 mcg of ethinylestradiol plus 2 mg of chlormadinone acetate reduces fat mass.

BACKGROUND: We aimed to evaluate whether a six-cycle treatment with oral contraceptive containing 30 mcg of ethinylestradiol (EE2) plus 2 mg of chlormadinone acetate (CMA) (EE2+CMA) alters body weight (BW) and body composition of healthy young women with normal menstrual cycles. The results in treated subjects were compared to those obtained in nontreated women as control. STUDY DESIGN: Multifrequency bioelectrical impedance analysis (MF-BIA) was performed in 48 healthy young women during the follicular phase of their menstrual cycle. Of this group, 24 women were treated with EE2+CMA, and the MF-BIA was repeated at the third and sixth cycle of treatment. The remaining 24 women were submitted to the same examinations after three and six cycles without any treatment. Total body water (TBW), intracellular water (ICW), extracellular water (ECW), fat mass (FM) and fat-free mass (FFM) were calculated. Waist-to-hip ratio (WHR), BW, blood pressure, and the plasma concentrations of electrolytes were also measured at each visit. RESULTS: Mean FM significantly (p<.05) decreased in the EE2+CMA group from basal levels of 14.23+/-1.03 to 13.51+/-1.09 and 12.71+/-1.02 kg at the third and sixth cycle of treatment, respectively. Stable values were seen in the control group. During observation, other parameters (BW, WHR, TBW, ECW, ICW, FFM) remained unchanged in all subjects. CONCLUSIONS: EE2+CMA reduces FM without altering TBW, ICW, ECW. These preliminary results suggest that progestational activity of CMA could balance both fluid retention and weight gain elicited by EE2.