Brazilian Portuguese Translation and Validation of the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA revised.

INTRODUCTION AND HYPOTHESIS: Condition-specific sexual questionnaires are important patient-reported outcome measures. The aim of this study was to translate and validate the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-International Urogynecology Association Revised (PISQ-IR) into Brazilian Portuguese and to clinically validate it in a Brazilian Portuguese-speaking population. METHODS: Translation and validation of the PISQ-IR was performed according to the International Urogynecological Association-recommended process and guidelines. For external validity, PISQ-IR subscales were compared with the clinical measures, Pelvic Organ Prolapse Quantification system (POP-Q) stage, pelvic floor muscle tone, and Oxford Grading Scale (Pearson correlations). Descriptive statistics, internal consistency (Cronbach's alpha coefficient), and test-retest reliability (interclass correlation coefficient) were calculated for all PISQ-IR subscales. RESULTS: A total of 120 sexually active and 106 not sexually active women were enrolled in the study between March 2015 and July 2019. Internal consistency was acceptable, with Cronbach's alpha values 0.60-0.80, except for the sexual arousal and orgasm, sexual arousal and partner-related issues, sexual arousal and condition-specific issues, global rating of sexual quality and condition impact subscales. PISQ-IR demonstrated good reliability (α > 0.6, CIC = 0.996). The agreement for each individual questionnaire item also individually presented substantial agreement between the assessments (κ 0.61-0.8). There was a correlation between PISQ-IR and POP, mixed, stress and fecal incontinence diagnosis and a positive correlation with pelvic floor muscle function according to the Oxford Scale in sexually active women. For sexually inactive women there was a correlation between PISQ-IR and mixed urinary symptoms. CONCLUSIONS: The Brazilian Portuguese version of PISQ-IR is a reliable and valid tool that can be easily used for the identification and assessment of sexual function in Brazilian Portuguese-speaking women with pelvic floor disorders.

Evaluation of tumor infiltrating lymphocytes as a prognostic biomarker in patients with ductal carcinoma in situ of the breast.

PURPOSE: To assess the association between tumor-infiltrating lymphocytes (TILs) in ductal carcinoma in situ (DCIS) samples and disease recurrence. METHODS: This retrospective cohort study included women aged 18 years and older who underwent treatment between January 2007 and December 2020. Male patients, individuals diagnosed with invasive or microinvasive disease based on anatomopathological examination of surgical specimens, and those with a personal history of any other cancers were excluded. Additionally, the presence of "touching TILs" (lymphocytes in direct contact with tumor cells) and periductal desmoplasia were evaluated as complementary methods to represent the immunological microenvironment. The primary outcome was relapse-free survival based on TIL quantification adjusted for potential confounders. Pathologists assessed TILs in the sample with the highest tumor representation and quantified them as a percentage. Survival was evaluated using Kaplan‒Meier curves, log-rank tests, and Cox regression models. RESULTS: A total of 191 patients met the eligibility criteria. The mean follow-up duration was 77.2 months, with a recurrence rate of 9.2%. Patients with TILs ≥ 17% had a greater risk of recurrence (HR 2.97, 95% CI 1.17-7.51; p = 0.02). Additionally, focal necrosis (HR 6.4, 95% CI 1.39-34.71; p = 0.018) or comedonecrosis (HR 4.53, 95% CI 1.34-15.28; p = 0.015) were associated with increased recurrence risk. According to the multivariate model, comedonecrosis and TILs ≥ 17% were significantly associated with recurrence (p = 0.034 and p = 0.035, respectively). Regarding the evaluations of "touching TILs" and periductal desmoplasia, no statistical significance was found when assessing their association with disease recurrence. CONCLUSION: In our cohort, a high percentage of TILs (≥ 17%) and the presence of comedonecrosis were independently associated with DCIS recurrence.

Can cognitive behavioral therapy improve vasomotor symptoms and recurrent depression in postmenopausal women?

OBJECTIVE: The aim of this study was to evaluate the effectiveness of cognitive behavioral therapy in the treatment of vasomotor, sexual dysfunction, and recurrent depression in postmenopausal women. METHODS: This prospective, open study evaluated 112 postmenopausal women with vasomotor symptoms. Sexual dysfunction has cultural, social, biological, and emotional issues and divided into two groups: G1, without depression (n=65) and G2, with recurrent depression (n=47). The subjects underwent 12 sessions of in-person cognitive behavioral therapy and 12 sessions of home-based activity over a period of 6 months. They were evaluated at 3 months following the completion of therapy. Depression, memory, and attention-related functions, as well as climactic symptoms, were assessed using a questionnaire. RESULTS: In the depression questionnaire, the G1 group had a lower initial score than the G2 group (p<0.01). Following 6 months of therapy, both groups had similar improved scores. In the depression questionnaire, the women in group G1 had higher baseline values. In the assessment of vasomotor symptoms, the values in both groups were similar and showed an improvement in vasomotor symptoms after 24 weeks of treatment, but these effects disappeared after the follow-up of 48 weeks in the G2 group. Both groups improved the sexual dysfunction after 24 weeks. CONCLUSION: Cognitive behavioral therapy may be effective in reducing vasomotor symptoms and ameliorate the sexual dysfunction and recurrent depression in postmenopausal women after 24 weeks of treatment.

Gynecologic health care for LGBTQIA+ people.

Gender relations are a set of socially determined norms and rules that assign values, characteristics, and expectations to individuals based on their biological sex. These aspects also influence the clinician-patient relationship, since it has been for a long time based on cisheteronormativity. However, this attitude alienated the LGBTQIA+ community from health services. Global and specific gynecologic care needs to be offered to the LGBTQIA+ population, which has demands for sexual and reproductive health care. In this narrative review, we bring conceptual aspects, gender identity and expression, sexual history, screening for cancer and other care to the community.

Cross-sectional study of self-reported pain related to temporomandibular disorders and emotional state of medical school faculty and students: Post-COVID-19 pandemic.

The social isolation imposed by the COVID-19 pandemic interrupted in-person activities, which were immediately followed by adaptations to ensure, for example, the continuity of teaching. This generated emotional impacts on the academic community. Emotional states may trigger or emphasize conditions such as temporomandibular dysfunction (TMD), causing pain and limiting masticatory function. This study aimed to compare the students and the faculty of a medical school first in terms of the TMD-caused pain they experienced during social isolation and reported two months later, according to their recollections, using the TMD-Pain Screener questionnaire. The second basis for comparison was the emotional state generated by social isolation and its connection with TMD symptoms assessed through the Depression, Anxiety and Stress Scale (DASS-21), which considers perceptions at the time of data collection. Both questionnaires were responded to in May 2022 after the end of social isolation. The data were analyzed by the IBM-SPSS software for Windows 22.0 with a 5% level of significance. The results show that the self-reported TMD symptoms were more widespread (p = 0.002) and intense (p = 0.013) among students than among faculty and that all of the former's DASS-21 domains (depression, anxiety, and stress) were also more strongly evident (p<0.05). Only anxiety was more significant among the faculty (p = 0.027). Both groups pointed to social isolation as an aggravating factor of the symptoms (p<0.05). The conclusion is that the self-reported TMD-caused pain and all DASS-21 domains as experienced during social isolation were stronger and more prevalent among students than among faculty, and that only anxiety was statistically significant among faculty. Also, the emotional states resulting from social isolation may have aggravated TMD-caused pain in both groups.

Combined oral contraceptive use and obesity in women with polycystic ovary syndrome. A meta-analysis of randomized clinical trials.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a heterogenous endocrine condition and combined oral contraceptives (COCs) have been demonstrated to be the first-line treatment to women who do not intend to become pregnant. The combination of COCs and PCOS may or may not amplify the risks of cardiovascular events. OBJECTIVE: To investigate whether surrogates for obesity may be influenced by the use of COCs containing different formulations in women with PCOS. METHOD: From January 2024 a literature search was conducted in Google Scholar and Pubmed databases using PCOS, COC, and obesity terms. Hand search of randomized clinical trials in the references of obtained manuscripts was also performed. After the exclusion of reviews and articles that did not fulfill eligibility criteria, compared the results obtained before and after the use of COCs in 13 randomized clinical trials (RCTs). Random-effects model was used to estimate the standardized mean differences (SMD) and standard errors (SE). Risk of bias was examined using the Rob2 tool. RESULT: Thirteen heterogeneous RCTs reported no difference in waist circumference with the use of different COC formulations (p = 0.714). On the contrary, body fat mass increased with the use of pill (p = 0.013). Waist triglyceride index and lipid accumulation product tended to be higher after the use of COCs (p = 0.073 and p = 0.064, respectively). CONCLUSION: Combined oral contraceptives with different formulations might increase fat mass accumulation in women with PCOS. Lipids may also be increased in PCOS users. Because some concerns about the quality and heterogeneity identified in various RCTs, caution should be taken before a definitive conclusion regarding the use of COCs and obesity.

Multifactorial assessment of braking time predictors in a driving simulator among older adults according to gender.

CONTEXT: Vehicle driving depends on the integration of motor, visual, and cognitive skills to respond appropriately to different situations that occur in traffic. OBJECTIVES: To analyze a model of performance predictor for braking time in the driving simulator, using a battery of tests divided by gender. METHODS: Selected were 100 male drivers with a mean age of 72.6 ± 5.7 years. Sociodemographic variables, braking time in the driving simulator, and motor, visual, and cognitive skills were evaluated. RESULTS: Comparing genders, men were older than women (p = 0.002) and had longer driving times (p = 0.001). Men had more strength in hand grip (p ≤ 0.001). In the linear regression analysis, the model explained 68 % of the braking time in men and 50.8 % in women. In the stepwise multiple linear regression analysis, the variable that remained in the model was the strength of the right plantar flexors, which explained 13 % of the braking time in women and men, and the cognitive variables explained 38.9 %. CONCLUSION: Sociodemographic, motor, visual, and cognitive variables, explained a substantial portion of the variability in braking time for both older women and men, the specific variables driving this performance differed between the sexes. For older women, factors such as muscle strength emerged as critical determinants of braking ability, highlighting the importance of physical health in maintaining driving skills. On the other hand, cognitive conditions emerged as the primary predictor of braking performance in older men, underscoring the role of mental acuity and decision-making processes in safe driving.

The decline in postural balance has a negative impact on the performance of functional tasks in individuals with Parkinson's Disease.

INTRODUCTION: An accurate assessment of balance problems is critical for decreasing the risk of falling in patients with Parkinson's Disease (PD). Reliable diagnostic tools such as Computerized Dynamic Posturography (CDP) are not feasible for the clinical setting. Therefore, the present study's aim was to assess the correlation between the clinical Balance Evaluation Systems Test (BESTest) and CDP. METHODS: 20 male older adults with Parkinson's Disease (PD) were included in this study. Participants first executed the Sit-To-Stand (STS), Step/Quick turn (SQT), and Step Up and Over (SUO) tests on a Balance Master® force platform, followed by a clinical balance evaluation using the BESTest. RESULTS: Four outcomes of the CDP were negatively correlated with one or more BESTest domains or total BESTest score: STS sway velocity was negatively correlated with the anticipatory postural adjustment (p = 0.02) and sensory orientation (p = 0.01) domains. SQT turn time was negatively correlated with biomechanical restriction (for turns to the left, p = 0.01, and right, p = 0.03, respectively), postural response (p = 0.01, p = 0.01), dynamic balance during gait (p = 0.007, p = 0.001), and total score (p = 0.02, p = 0.01). Step over time to the right in SUP was negatively correlated with the limits of the stability domain (p = 0.002) and total BESTest score (p = 0.020). SUO impact index was negatively correlated with the anticipatory postural adjustment domain (p = 0.01). CONCLUSION: This study shows that several BESTest domains are significantly correlated with CDP outcomes, demonstrating that the BESTest can be used as a more clinically feasible alternative for computerized posturography, without loss of information.

Efficacy of Cognitive Behavioral Therapy in treating women with endometriosis and chronic pelvic pain: A randomized trial.

This study seeks to assess the efficacy of Cognitive-Behavioral Therapy (CBT) in enhancing coping strategies, alleviating depression, stress, pain perception, and improving the quality of life for women with endometriosis. About 52 patients randomized, categorized into an intervention group (n = 25) and a control group (n = 27) filled out the instruments. A significant positive change was observed in all variables studied within the intervention group compared to the control group. This study introduced a psychological treatment protocol focused on refining coping strategies using CBT techniques. Following the promotion of adaptive coping, there was an improvement in scores related to depression, stress, quality of life, perception of pain, and emotional distress. This suggests that CBT is effective in enhancing the overall emotional wellbeing of women with endometriosis.

Treatment with Raloxifene Induces the Expression of Kisspeptin, Insulin, and Androgen Receptors in Bones of Castrated Adult Female Rats.

Objective To evaluate the effects of estrogen, raloxifene and genistein on the expression of KISS1 (kisspeptin), KISS1R (kisspeptin receptor), AR (androgen receptor) and INSR (insulin receptor) in the bones of ovariectomized rats. Methods Forty-eight adult rats were randomly divided into 6 groups, containing 8 animals each: G1-nonovariectomized control; G2-ovariectomized and treated with conjugated equine estrogens (50 µg/Kg/day); G3-ovariectomized and treated with raloxifene (0.75 mg/kg/day); G4-ovariectomized animal that received soy extract with genistein (300 mg/kg/day); G5-ovariectomized animal that received estrogen and genistein; and G6-ovariectomized animal that received estrogen and raloxifene. Three months after surgery, the castrated animals received the drugs orally daily for 120 days. All animals were sacrificed after this period, by deepening the anesthesia. The left tibia was removed for total RNA extraction and analysis of gene expression of KISS1 , KISS1R , AR and INSR , by quantitative real-time polymerase chain reaction (qRT-PCR). Results KISS1 was not detected in any of the treated groups. KISS1R , INSR and AR showed higher expression in the G3 group ( p < 0.001), while lower levels of transcripts for these genes were observed in G4 and G5. G2 animals showed hypoexpression of the evaluated genes. Conclusion The results indicate that raloxifene, alone or combined with estrogen, was able to induce the expression of genes associated with the recovery of bone tissue homeostasis in ovariectomized rats.

Antioxidant Actions of Melatonin: A Systematic Review of Animal Studies.

Melatonin is an indoleamine with crucial antioxidant properties that are used to combat inflammatory and neoplastic processes, as well as control transplants. However, the clinical applications of melatonin have not yet been fully consolidated in the literature and require in-depth analysis. OBJECTIVES: This study reviewed the literature on the antioxidant properties of melatonin in rat models. METHODS: We followed the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses and used the PubMed, LILACS, and Cochrane databases, Google Scholar, and article references, irrespective of publication time. RESULTS: Ten articles involving 485 rats were selected, and the effects of melatonin on antioxidant markers were investigated. Melatonin increased superoxide dismutase in nine studies, glutathione peroxidase in seven studies, and catalase in five studies. In contrast, melatonin reduced glutathione in three studies and malonaldehyde in seven of eight studies. CONCLUSION: Our findings suggest that melatonin effectively reduces oxidative stress.

FOXO3a deregulation in uterine smooth muscle tumors.

OBJECTIVE: The present study aimed to investigate FOXO3a deregulation in Uterine Smooth Muscle Tumors (USMT) and its potential association with cancer development and prognosis. METHODS: The authors analyzed gene and protein expression profiles of FOXO3a in 56 uterine Leiomyosarcomas (LMS), 119 leiomyomas (comprising conventional and unusual leiomyomas), and 20 Myometrium (MM) samples. The authors used techniques such as Immunohistochemistry (IHC), FISH/CISH, and qRT-PCR for the present analyses. Additionally, the authors conducted an in-silico analysis to understand the interaction network involving FOXO3a and its correlated genes. RESULTS: This investigation revealed distinct expression patterns of the FOXO3a gene and protein, including both normal and phosphorylated forms. Expression levels were notably elevated in LMS, and Unusual Leiomyomas (ULM) compared to conventional Leiomyomas (LM) and Myometrium (MM) samples. This upregulation was significantly associated with metastasis and Overall Survival (OS) in LMS patients. Intriguingly, FOXO3a deregulation did not seem to be influenced by EGF/HER-2 signaling, as there were minimal levels of EGF and VEGF expression detected, and HER-2 and EGFR were negative in the analyzed samples. In the examination of miRNAs, the authors observed upregulation of miR-96-5p and miR-155-5p, which are known negative regulators of FOXO3a, in LMS samples. Conversely, the tumor suppressor miR-let7c-5p was downregulated. CONCLUSIONS: In summary, the outcomes of the present study suggest that the imbalance in FOXO3a within Uterine Smooth Muscle Tumors might arise from both protein phosphorylation and miRNA activity. FOXO3a could emerge as a promising therapeutic target for individuals with Unusual Leiomyomas and Leiomyosarcomas (ULM and LMS), offering novel directions for treatment strategies.

A randomized clinical trial comparing internal and external pessaries in the treatment of pelvic organ prolapse in postmenopausal women: A pilot study.

INTRODUCTION AND HYPOTHESIS: Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently developed as an alternative. The study's objective was to compare the efficacy of external and internal pessaries in treating POP in postmenopausal women. METHODS: This parallel randomized (1:1 ratio) open-blind study included 40 symptomatic women with stage 2 or 3 POP. They were randomized into two groups: group 1 (internal pessary) and group 2 (external pessary) (n = 20 in each); and evaluated at the start of and 3 months after the treatment. Statistical analysis was performed to compare the results within and between the groups before and after the 3-month treatment. RESULTS: The groups were homogeneous, except for the variables previous pregnancies (p = 0.030) and POP-Q score of apical prolapse (p = 0.023) whose values were higher in group 2. A significant improvement in quality of life was observed in both groups after 3 months of follow-up; however, internal pessaries were found to be more effective (p < 0.001). In group 1 there were differences between the initial and final POP-Q scores of anterior (0.004) and apical prolapse (p = 0.005). The complication rate associated with internal pessary use was high (p = 0.044). CONCLUSIONS: The present data suggested that external pessaries have a similar effect to internal ones for the treatment of POP and improvement of the quality of life of postmenopausal women.

Pap Smear Cancer Coverage in Brazilian Capitals including the Pandemic Period Caused by the SARS-CoV-2 Virus: Ecological Study.

INTRODUCTION: Cervical cancer develops slowly and may not manifest signs and symptoms at an early stage. It is worth mentioning the factors that can influence the onset of cervical cancer: smoking, early sexual life, multiple sexual partners, use of oral contraceptives, multiparity, low socioeconomic status, among others. An important risk factor for the onset of this disease is HPV infection, a virus associated with most cases of precursor lesions of this type of cancer. It is essential to understand the comprehensiveness of the scope and adherence to the recommended guidelines throughout the national territory. Therefore, health indicators are important management tools that make it possible to evaluate the services offered, measuring the reach of the target population, the supply and access to preventive exams. OBJECTIVE: To analyze the trend of progress in cervical cancer coverage actions in Brazilian capitals from 2016 to 2021. METHOD: This is an ecological study with temporal analysis that used secondary data referring to process indicators for cervical cancer control actions in women aged between 25 and 64 years living in Brazilian capitals between 2016 and 2021. Aspects related to the quality of care in the cervical cancer prevention program were evaluated using databases of the Cancer Information System (SISCAN), available in DATASUS. The indicators used to monitor and evaluate cervical cancer control actions were (i) cervical coverage, (ii) reason for cervical surgery, and (iii) proportion of cervical cancer every 3 years. RESULTS: In 2016, 410,000 tests were performed and notified in the SISCAN system in all Brazilian capitals, with emphasis on Curitiba, with 65,715 tests performed, and Porto Velho, with 174. In 2020, there was a reduction in exams compared to the previous year in all capitals, with the exception of Palmas, which went from 7655 exams to 9604. It was observed that all the capitals studied showed an increase in the annual percentage variation of Pap smear coverage, with the exception of Brasília, Manaus, Porto Alegre and Porto Velho, which did not show a statistically significant increase (APC = 3.01, 2.746, 3.987, 3.69, respectively). When analyzing the performance of oncotic cytology exams in the capitals according to the years 2019 and 2020, it was observed that only Manaus registered an increase in the number of procedures performed, reaching a difference of 56.5% from one year to the next. CONCLUSION: The ecological analysis revealed a worrying drop in the number of tests performed in 2020, reflecting a sharp drop in coverage actions in Brazilian capitals during the pandemic caused by the SARS-CoV-2 virus. The pandemic has exacerbated existing inequalities and highlighted the need for adaptive strategies to maintain essential screening services in times of crisis.

Advanced glycation end products consumption and the decline of functional capacity in patients with Parkinson's disease: Cross-sectional study.

INTRODUCTION: Advanced Glycation End-Products (AGEs) are a diverse group of highly reactive molecules that play a vital role in the development of neurodegenerative disorders, such as Parkinson's Disease (PD), leading to a decline in functional and cognitive capacity. The objective of this study was to assess the intake and quantification of AGEs in individuals with PD and to correlate them with their functional and cognitive abilities. METHODS: This was a cross-sectional study involving 20 PD patients and 20 non-PD individuals as the Control group (C). The autofluorescence reader was used to evaluate skin AGEs, while food recall was used to quantify AGEs consumed for three different days. The Montreal Cognitive Assessment, Short Physical Performance Battery, and handgrip tests were used. PD patients demonstrated greater impairment in functional capacity compared to the control group. RESULTS: Dominant Handgrip (p = 0.02) and motor performance, in the sit and stand test (p = 0.01) and Short Physical Performance Battery (SPPB) (p = 0.01) were inferior in PD patients than the control group. Although PD patients tended to consume less AGEs than the control group, AGE intake was negatively correlated with handgrip strength in individuals with PD (r = -0.59; p < 0.05). CONCLUSION: PD patients had lower strength and functional capacity, suggesting that the effects of AGEs might be exacerbated during chronic diseases like Parkinson's.

Bisphenol A and polycystic ovary syndrome in human: A systematic review.

BACKGROUND: Polycystic ovary syndrome (PCOS) is an endocrine disorder characterized by anovulation, hyperandrogenism, and polycystic ovarian morphology. Its etiology is uncertain and one of the hypotheses is that environmental factors, such as the bisphenol A (BPA) endocrine disruptor, may be involved. OBJECTIVE: To investigate the association between exposure to BPA and PCOS. SEARCH STRATEGY: Research was conducted focusing on studies published in English, Portuguese, and Spanish from January 2001 to March 2023 and available in Embase, Medline/PubMed, Rima, Lilacs, Scielo, Google academic, and SCI databases. SELECTION CRITERIA: Studies in humans that evaluated the association between exposure to BPA and a diagnosis of PCOS. DATA COLLECTION AND ANALYSIS: Following PRISMA guidelines, study characteristics and relevant data were extracted. MAIN RESULTS: Selection of 15 case-control and 7 cross-sectional studies with a total of 1682 PCOS patients. The studies were carried out in China, Poland, Turkey, Japan, Greece, Italy, the USA, Iran, Iraq, Egypt, India, Czechia, and Slovakia. A positive relationship between exposure to BPA and PCOS was described in19 studies (1391 [82.70%] of the PCOS patients). The fluids used in the studies were serum, urine, plasma, and follicular fluid. BPA was measured by ELISA and by chromatography (HPLC, HPLC-MS/MS, GC-MS, and GC-MS/MS). Diagnosis of PCOS used Rotterdam criteria in 15, NIH 1999 in 3, AE&PCOS Society in 2, similar to the Rotterdam criteria in 1, and criteria not informed in 1. Androgens were measured in 16 studies; in 12, hyperandrogenism was positively associated with BPA. BPA level was related to body mass index (BMI) in studies. In 15 studies independently of BMI, women with PCOS had higher BPA levels. Carbohydrate metabolism disorders were evaluated in 12 studies and in 6 a positive correlation was found with BPA levels. Lipid profile was evaluated in seven studies and in only one the correlation between lipid profile and BPA levels was present. CONCLUSIONS: Exposure to BPA is positively associated with PCOS, mainly with the hyperandrogenism.

Pilot study of treatment of patients with deep infiltrative endometriosis with methotrexate carried in lipid nanoparticles.

OBJECTIVE: Previously, lipid nanoparticles (LDE) injected in women with endometriosis were shown to concentrate in the lesions. Here, the safety and feasibility of LDE carrying methotrexate (MTX) to treat deep infiltrating endometriosis was tested. DESIGN: Prospective pilot study. SETTING: Perola Byington Hospital Reference for Women's Health. SUBJECTS: Eleven volunteers (aged 30-47 years, BMI 26.15 ± 6.50 kg/m2) with endometriosis with visual analog scale pelvic pain scores (VAS) > 7 and rectosigmoid lesions were enrolled in the study. INTERVENTION: Three patients were treated with LDE-MTX at single intravenous 25 mg/m2 dose of MTX and eight patients with two 25 mg/m2 doses with 1-week interval. MAIN OUTCOME MEASURES: Clinical complaints, blood count, and biochemistry were analyzed before treatment and on days 90, 120, and 180 after LDE-MTX administration. Endometriotic lesions were evaluated by pelvic and transvaginal ultrasound (TVUS) before treatment and on days 30 and 180 after LDE-MTX administration. RESULTS: No clinical complaints related with LDE-MTX treatment were reported by the patients, and no hematologic, renal, or hepatic toxicities were observed in the laboratorial exams. FSH, LH, TSH, free T4, anti-Müllerian hormone, and prolactin levels were also within normal ranges during the observation period. Scores for deep dyspareunia (p < 0.001), chronic pelvic pain (p = 0.008), and dyschezia (p = 0.025) were improved over the 180-day observation period. There was a non-significant trend for reduction of VAS scores for dysmenorrhea. Bowel lesions by TVUS were unchanged. No clear differences between the two dose levels in therapeutic responses were observed. CONCLUSION: Results support the safety and feasibility of using LDE-MTX in women with deep infiltrating endometriosis as a novel and promising therapy for the disease. More prolonged treatment schemes should be tested in future placebo-controlled studies aiming to establish the usefulness of this novel nanomedicine approach.