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.

Systemic therapy for the treatment of endometrial cancer.

Introduction: Endometrial cancer (EC) is one of the most frequent gynecological cancers worldwide. The gold standard treatment of EC is most certainly surgery and may very well be the only therapy in the early stages of disease. To improve outcomes in non-early EC, adjuvant therapy is often employed but this is not standardized. Adjuvant options can include radiotherapy, chemotherapy or a combination of both. Adjuvant chemotherapy could be indicated in high-risk stage I and II or advanced stage EC. Several clinical trials are ongoing in an attempt to define the optimal adjuvant treatment. Furthermore, chemotherapy is the front-line therapy in advanced unresectable, metastatic or recurrent endometrial cancer. Areas covered: Herein, the authors review the first-line chemotherapy for the treatment of endometrial cancer and provide their expert perspectives on these therapies. Expert opinion: Chemotherapy is fundamental in advanced/recurrent EC. Further evidence is needed to characterize the role of adjuvant chemotherapy. Future studies should consider genomic and molecular heterogeneities to identify even more efficient tailored therapies.

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.

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.

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.

Deep Infiltrating Endometriosis: Comparison Between 2-Dimensional Ultrasonography (US), 3-Dimensional US, and Magnetic Resonance Imaging.

OBJECTIVES: To evaluate the diagnostic accuracy of 2-dimensional (2D) and 3-dimensional (3D) transvaginal ultrasonography (US) in comparison with magnetic resonance imaging (MRI) for identification of deep infiltrating endometriosis. METHODS: In this prospective observational study, 159 premenopausal women who underwent surgery for a clinical suspicion of deep infiltrating endometriosis were prospectively enrolled. All women underwent 2DUS, 3DUS, and MRI. The following 3 locations of deep endometriosis were considered: (1) intestinal; (2) other posterior lesions (retrocervical septum, rectovaginal septum, uterosacral ligaments, and vaginal fornix); and (3) anterior. The sensitivity, specificity, positive predictive value, and negative predictive value of 2D and 3D transvaginal US in comparison with MRI were determined. RESULTS: Intestinal deep infiltrating endometriosis was identified by 2DUS in 56 of 66 patients, by 3DUS in 59 of 66, and by MRI in 61 of 66. A receiver operating characteristic curve analysis showed optimal results for 2DUS, 3DUS, and MRI (areas under the curve, 0.86, 0.915, and 0.935, respectively) with a statistically significant difference between 2DUS and MRI (P = .0103), even when the 95% confidence interval showed an overlap. Other posterior deep infiltrating endometriosis was identified by 2DUS in 55 of 75 patients, by 3DUS in 65 of 75, and by MRI in 66 of 75. A receiver operating characteristic curve analysis showed very good results for 2DUS, 3DUS, and MRI (areas under the curve, 0.801, 0.838, and 0.857) with no statistically significant differences. In the 12 women with deep infiltrating endometriosis in the anterior location, the nodules were correctly identified by 2DUS in 3 of 12 patients, by 3DUS in 5 of 12, and by MRI in 6 of 12. CONCLUSIONS: Our results seem to suggest that there is a statistically significant difference between 2DUS and MRI for the intestinal location of deep infiltrating endometriosis, whereas no differences were found among the techniques for the other locations.

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.

Overview of elagolix for the treatment of endometriosis.

INTRODUCTION: Suppression of sex-steroid secretion is required in a variety of gynecological conditions. This can be achieved using gonadotropin releasing hormone (GnRH) agonists that bind pituitary gonadotropin receptors and antagonize the link-receptor of endogenous GnRH, inhibiting the mechanism of GnRH pulsatility. On the other hand, GnRH antagonists immediately reduce gonadal steroid levels, avoiding the initial stimulatory phase of the agonists. Potential benefits of GnRH antagonists over GnRH agonists include a rapid onset and reversibility of action. Older GnRH antagonists are synthetic peptides, obtained by modifications of certain amino acids in the native GnRH sequence. They require subcutaneous injections, implantation of long-acting depots. The peptide structure is responsible for histamine-related adverse events and the tendency to elicit hypersensitivity reactions. AREAS COVERED: Research has worked towards the development of non-peptidic molecules exerting antagonist action on GnRH. They are available for oral administration and may have a more beneficial safety profile in comparison with peptide GnRH antagonists. This article focuses on the data of the literature about elagolix, a novel non-peptidic GnRHantagonist, in the treatment of endometriosis. EXPERT OPINION: Elagolix demonstrated efficacy in the management of endometriosis-associated pain and had an acceptable safety and tolerability profile. However, further studies are necessary to evaluate its non-inferiority in comparison with other endometriosis's treatments.

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".

S100B protein expression in the heart of deceased individuals by overdose: a new forensic marker?

OBJECTIVE: The evaluation of S100B protein expression in the human heart and its correlation with drug-related death. METHOD: Left ventricular samples were collected from 74 serial forensic autopsies (15 overdose-related deaths; 59 non-overdose-related deaths) from 2007 to 2010. Tissue sections from each sample were immunostained for S100B protein by a commercial antibody. RESULTS: The S100B protein was detected in the heart samples of all 15 cases of drug-related deaths; S100B immunoreactivity was mainly observed in the cytoplasm of cardiomyocytes and as globular deposits in the interstitial spaces. No reactivity or weak reactivity was found in the cardiomyocytes of the 59 subjects who died of other causes. CONCLUSION: Our preliminary data show that the S100B protein accumulates in injured cardiomyocytes during drug-related sudden death. Given the near absence of S100B protein in the heart of subjects who died from causes other than drug overdose, S100B immunopositivity may be used as a new ancillary screening tool for the postmortem diagnosis of overdose-related cardiac death.

S100B protein expression in the heart of deceased individuals by overdose: a new forensic marker?

OBJECTIVE: The evaluation of S100B protein expression in the human heart and its correlation with drug-related death. METHOD: Left ventricular samples were collected from 74 serial forensic autopsies (15 overdose-related deaths; 59 non-overdose-related deaths) from 2007 to 2010. Tissue sections from each sample were immunostained for S100B protein by a commercial antibody. RESULTS: The S100B protein was detected in the heart samples of all 15 cases of drug-related deaths; S100B immunoreactivity was mainly observed in the cytoplasm of cardiomyocytes and as globular deposits in the interstitial spaces. No reactivity or weak reactivity was found in the cardiomyocytes of the 59 subjects who died of other causes. CONCLUSION: Our preliminary data show that the S100B protein accumulates in injured cardiomyocytes during drug-related sudden death. Given the near absence of S100B protein in the heart of subjects who died from causes other than drug overdose, S100B immunopositivity may be used as a new ancillary screening tool for the postmortem diagnosis of overdose-related cardiac death.

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.

Extragenital endometrial stromal sarcoma arising in endometriosis.

The diagnosis rate of deep pelvic endometriosis is increasing. Endometrial stromal sarcoma (ESS) is a rare neoplasm. Extragenital ESS is an extremely uncommon event. Very few cases of extragenital ESS have been reported to date. The diagnosis of this entity is very difficult in some instances. Knowledge about its management is also limited. In this paper, we review the current literature on the clinical management, histology, immunohistochemistry, treatment and outcome of ESS arising in pelvic endometriosis.

Intraoperative lymphatic mapping techniques for endometrial cancer.

Endometrial cancer is the most common malignancy of the female genital tract in developed countries. The primary treatment for women with endometrial cancer is surgical, as well as the staging of the pathological spread pattern of this carcinoma outside of the uterus. A complete surgical staging should include both pelvic and para-aortic lymphadenectomy. The vast majority of endometrial cancers are diagnosed at a very early stage owing to the early presentation as abnormal uterine bleeding. In women with early-stage endometrial cancer the systematic pelvic and para-aortic lymphadenectomy may produce additional morbidity without the benefit of appropriate surgical staging. The procedure of sentinel lymph node (SLN) biopsy after lymphatic mapping has been introduced for patients with cancers of various organs in an effort to avoid complete systematic lymphadenectomy whenever possible. In the case of gynecological malignancies, the reliability of the SLN detection procedure has been extensively investigated in vulvar and cervical cancer. This article focuses on the peculiar aspects of intraoperative lymphatic mapping techniques and SLN procedures in endometrial cancer.

Detection of benign intracavitary lesions in postmenopausal women with abnormal uterine bleeding: a prospective comparative study on outpatient hysteroscopy and blind biopsy.

STUDY OBJECTIVE: To evaluate the specificity of blind biopsy in detecting benign intracavitary lesions as causes of postmenopausal bleeding in comparison with directed biopsy via hysteroscopy. DESIGN: Prospective trial without randomization (Canadian Task Force classification II-1). SETTING: University hospital. PATIENTS: Three hundred nineteen postmenopausal women with abnormal uterine bleeding. INTERVENTIONS: All patients underwent both blind biopsy (Novak's curette) and directed biopsy via hysteroscopy (after at least a week). All patients with benign intracavitary lesions underwent operative hysteroscopy to enable the removal of polyps and intracavitary myomas or endometrial resection if required. All patients with pathologic reports of complex hyperplasia and atypical hyperplasia (20 patients) underwent vaginal hysterectomy with bilateral adnexectomy. All patients with histology reports of endometrial carcinoma (15 patients) underwent abdominal hysterectomy, bilateral adnexectomy, and pelvic lymphadenectomy. Histopathologic findings from endometrial specimens obtained after operative hysteroscopy or uterine specimens obtained after hysterectomy were used as a reference test to establish the prevalence of disease. MEASUREMENTS AND MAIN RESULTS: The sensitivity, specificity, accuracy, and positive and negative predictive values of blind biopsy and hysteroscopy were assessed to distinguish benign intracavitary formations such as polyps, submucous myomas, and endometrial hyperplasia in postmenopausal patients with abnormal uterine bleeding. The level of agreement was evaluated by use of the coefficient of concordance kappa. Blind biopsy showed a sensitivity of 11% and a specificity of 93%, with an accuracy of 59% in detecting endometrial polyps, a sensitivity and specificity of 13% and 100%, respectively, with an accuracy of 98% for submucous myomas, and values of 25%, 92%, and 80%, respectively, in diagnosing hyperplasia. On the other hand, hysteroscopy demonstrated a sensitivity of 100% and a specificity of 97%, with an accuracy of 91% in diagnosing endometrial polyps, a sensitivity and specificity of 100% and 98%, respectively, with an accuracy of 99% for submucous myomas. The coefficient of concordance kappa (95% CI) was 0.12 for blind biopsy and 0.82 for hysteroscopy, corresponding, respectively, to slight concordance and almost perfect agreement with final pathologic diagnosis. CONCLUSIONS: Blind biopsy (Novak's curette) demonstrates very low sensitivity and accuracy in the diagnosis of benign focal intracavitary lesions. Hysteroscopy is confirmed as the gold standard in the assessment of abnormal uterine bleeding in menopause, permitting the elimination of the false-negative results of blind biopsy through direct visualization of the uterine cavity and the performance of targeted biopsy in case of doubt.

"Tenderness-guided" transvaginal ultrasonography: a new method for the detection of deep endometriosis in patients with chronic pelvic pain.

OBJECTIVE: To determine the accuracy of transvaginal ultrasonography (TVUS) using a modified "tenderness-guided" approach in the diagnosis of deep endometriosis of the cul-de-sac, retrocervical region, and rectovaginal septum. DESIGN: Prospective study. SETTING: Academic department of obstetrics and gynecology. PATIENT(S): Fifty women scheduled for laparoscopy for chronic pelvic pain. INTERVENTION(S): All patients underwent TVUS. The modified tenderness-guided approach consisted of TVUS combined with the introduction of 12 mL of ultrasound transmission gel (instead of the usual 4 mL) in the probe cover to create a stand-off to visualize the near-field area. The posterior fornix was evaluated accurately with an up-and-down sliding movement of the probe. In addition, when the patient indicated that tenderness was evoked by the probe's pressure, the sliding movement was stopped, and particular attention was paid to the painful site for detection of endometriosis lesions. MAIN OUTCOME MEASURE(S): Sensitivity, specificity, and kappa values. RESULT(S): Using this approach, we obtained a specificity of 95% with a sensitivity of 90%, associated with a very high kappa value of 0.86 (95% CI, 0.56-0.91). CONCLUSION(S): Our new TVUS approach appears to be an accurate, inexpensive, and less invasive method for the diagnosis of deep endometriosis.

Efficacy of intravenous tramadol treatment for reducing pain during office diagnostic hysteroscopy.

OBJECTIVE: To assess whether IV tramadol before outpatient hysteroscopy could reduce procedure-related pain. DESIGN: A randomized double-blind placebo controlled trial. SETTING: Outpatient Hysteroscopy Centre in the Department of Obstetrics and Gynaecology of Cagliari University. PATIENT(S): Fifty healthy, parous, women who underwent outpatient diagnostic hysteroscopy and endometrial biopsy. INTERVENTION(S): Random IV infusion of tramadol or placebo before hysteroscopy and endometrial biopsy were performed. MAIN OUTCOME MEASURE(S): Visual analogue scale of pain was measured both immediately after and 15 minutes after the procedure. Stress hormones (ACTH, cortisol), blood pressure, and heart frequency were evaluated before, during, and 15 minutes after the procedure. RESULT(S): In the tramadol group, the visual analogue scale of pain was significantly lower than in the placebo group both immediately after the procedure and 15 minutes later. Basal levels of ACTH and cortisol did not differ between the groups. In both groups, the ACTH levels remained unchanged during the study, and the cortisol levels were higher 15 minutes after the procedure than before the procedure. Procedure time, heart frequency, blood pressure, and adverse effects did not differ between the groups. CONCLUSION(S): In parous women without uterine malformations, a treatment with tramadol before hysteroscopy and endometrial biopsy appears to be capable of reducing the pain and discomfort that are associated with this procedure.

Ultrasonography and color Doppler-based triage for adnexal masses to provide the most appropriate surgical approach.

OBJECTIVE: This study was undertaken to identify whether ultrasonography with color Doppler can identify and triage the patients with adnexal masses to the most appropriate surgical approach. STUDY DESIGN: Four hundred fifty-three pelvic masses were included in the study and underwent ultrasonography before surgical treatment for adnexal masses. Masses that showed a typical benign pattern at B-mode ultrasonography (very low risk of malignancy) were treated by conventional laparoscopy without further evaluation. Masses that extended above the umbilicus were consider at very high risk and treated by laparotomy. All other adnexal masses were evaluated with power Doppler. Masses with central vascularization (high risk of malignancy) were submitted to laparotomy or laparoscopy with additional tools, whereas masses with peripheral or absent flow (low risk of malignancy) were submitted to conventional laparoscopy. RESULTS: Among 284 very low-risk, 32 low-risk, 46 high-risk, 91 very high-risk masses, the rate of malignant masses were 0%, 0%, 52%, and 78%, respectively. The use of color Doppler increases the diagnostic accuracy of B-mode ultrasonography in the diagnosis of adnexal malignancies because of a significantly higher specificity (0.91 vs 0.82, P < .001). CONCLUSION: The evaluation of vessel distribution by color Doppler seems a safe diagnostic procedure, permitting to treat by laparoscopy 91% of benign masses.