Association between different triglyceride glucose index-related indicators and depression in premenopausal and postmenopausal women: NHANES, 2013-2016.

BACKGROUND AND AIM: The association between the Triglyceride-glucose (TyG) index and depression has been observed, yet its confirmation within peri- and postmenopausal demographics remains elusive. Consequently, the principal aim of this investigation is to explore the nexus between TyG-related indicators and depressive symptoms among pre- and postmenopausal women. METHODS: The data utilized in this study were obtained from the National Health and Nutrition Examination Survey (NHANES) conducted from 2013 to 2016. The patients were divided into three groups based on TyG, Triglyceride-Glucose-Body Mass Index (TyG-BMI), Triglyceride-Glucose-Waist Circumference (TyG-WC), and Triglyceride-Glucose-Waist-to-Height Ratio (TyG-WHtR): Q1 (1st quintile), Q2 (2nd quintile), and Q3 (3rd quintile). Further exploration of the differences between these groups was conducted. Employing logistic regression, stratified analysis, restricted cubic splines, and subgroup analyses, we scrutinized the correlation between TyG-related indicators and depressive symptoms in both premenopausal and postmenopausal women. Furthermore, sensitivity analyses were conducted to assess the durability and uniformity of this relationship. RESULTS: In premenopausal women, there was a consistent independent positive correlation between TyG-BMI, TyG-WC, and TyG-WHtR with depressive symptoms across all three models, while TyG itself did not show a significant association. In Models 1 and 2, TyG-BMI exhibited a higher odds ratio (OR) value than the other two indicators [Model 1, Q3 OR (95 % confidence interval, CI) = 3.37 (1.91-5.94); Model 2, Q3 OR (95 % CI) = 3.03 (1.67-5.52)]. In Models 3, TyG-WHtR demonstrates a more significant association with depressive symptoms [Model 3, Q3 OR (95 % CI) = 2.85 (1.55-5.27)]. This correlation does not manifest in menopausal women. CONCLUSIONS: In premenopausal women, TyG-BMI, TyG-WC, and TyG-WHtR exhibited a positive and linear relationship with depressive symptoms. Furthermore, the analysis revealed that the combined measures of TyG-BMI, TyG-WC, and TyG-WHtR offered greater precision and sensitivity in assessing this association compared to TyG alone.

The risk of depression in the menopausal stages: A systematic review and meta-analysis.

INTRODUCTION: For many women, menopause transition can be a period of emotional and physical changes, with different menopausal stages associated with varied risk for depressive symptoms and diagnosis. This review aimed to conduct a systematic review and meta-analyses to provide an estimate for the risk of developing a) clinical depression and b) depressive symptoms at different menopausal stages. METHODS: We searched Medline, PsycInfo, Embase and Web of Science from inception to July 2023. Seventeen prospective cohort studies with a total of 16061 women were included in the review, and risk of bias was assessed using the Quality in Prognosis Studies tool (QUIPS). Seven papers with a total of 9141 participants were included in meta-analyses, using random effects models and pooled odds ratios (OR) calculated for depressive symptoms and diagnoses. RESULTS: Perimenopausal women were found to be at a significantly higher risk for depressive symptoms and diagnoses, compared to premenopausal women (OR = 1.40; 95 % CI: 1.21; 1.61, p < .001). We did not find a significantly increased risk for depressive symptoms or diagnoses in post-menopausal, compared to pre-menopausal women. LIMITATIONS: Studies used different criteria to classify the menopausal stages and different measures for depression, which may have contributed to the heterogeneity seen in some models. We were unable to include a model that compared peri to post-menopause, due to a lack of longitudinal studies comparing the two stages. CONCLUSIONS: The risk of depression in perimenopause, shown in an ethnically diverse sample; highlights the clinical need for screening and support in this potentially vulnerable group.

Reproductive aging and executive functions in healthy women.

The aim of this study was to analyze the influence of reproductive aging on executive functions. We assessed executive functions in three groups of healthy women in the premenopausal (n = 45, mean age = 30.89, SD = 10.5), perimenopausal (n = 31, mean age = 50.06, SD = 3.6) and postmenopausal (n = 24, mean age = 63.39, SD = 6.5) phase. No differences between groups were observed in working memory, verbal fluency, inhibitory control, planning, and cognitive flexibility. However, when the analyses were repeated with participants with occupations with lower intellectual demands, perimenopausal and postmenopausal women performed worse than premenopausal women in semantic verbal fluency. This study provides important evidence to understand the effects of reproductive aging on cognitive performance in healthy women. Our findings indicate that cognitive reserve-related factors may be important to understand the differences in executive functions associated with reproductive aging.

Knowledge, attitudes and practices towards menopause among Congolese middle-aged and postmenopausal women.

INTRODUCTION: with the increase in life expectancy, women will live longer during their postmenopausal period. To improve their quality of life, they should be aware of what challenges they will be facing. This study aimed to evaluate the knowledge, attitudes and practices of middle-aged women towards menopause. METHODS: in this cross-sectional study, data collected using a multistage clustered random sampling from 54 health centres in the Democratic Republic of Congo were used. Participants filled a questionnaire derived from the menopause rating scale and from local beliefs. The knowledge, attitudes and practices towards menopause were evaluated among pre- and postmenopausal women. RESULTS: of the 353 women, both pre- and postmenopausal women knew the definition of menopause but for the symptoms, postmenopausal women were more informed than premenopausal. For the attitudes and practices towards menopause, while both had equally positive attitudes, the premenopausal women did not know which practice to adopt. CONCLUSION: Congolese women had limited knowledge, positive attitudes and unconventional practices towards menopause. Health-care providers, therefore, need to dispense appropriate advice to middle-aged women before the advent of menopause.

What happens after menopause? (WHAM): A prospective controlled study of depression and anxiety up to 12 months after premenopausal risk-reducing bilateral salpingo-oophorectomy.

OBJECTIVE: Risk-reducing bilateral salpingo-oophorectomy (RRBSO) substantially reduces ovarian cancer risk in women with pathogenic gene variants and is generally recommended by age 34-45 years. Natural menopause is a vulnerable period for mood disturbance, but the risk of depression and anxiety in the first 12 months after RRBSO and potential modifying effect of hormone therapy are uncertain. METHODS: Prospective controlled observational study of 95 premenopausal women planning RRBSO and a Comparison group of 99 premenopausal women who retained their ovaries,- 95% of whom were at population level risk of ovarian cancer. Clinically significant symptoms of depression and anxiety were measured using standardised instruments at baseline, 3, 6 and 12 months. Chi-square tests and adjusted logistic regression models compared differences between groups. RESULTS: Baseline symptoms and previous depression or anxiety did not differ between groups. At 3 months after RRBSO clinically significant depressive symptoms were doubled (14.5% vs 27.1%, p = 0.010), which persisted at 12 months. Depressive symptoms were stable in comparisons. At 3 months after RRBSO, clinically significant anxiety symptoms almost trebled (6.1% vs 17.7%, p = 0.014) before plateauing at 6 months and returning to baseline at 12 months. Compared to comparisons, RRBSO participants were at 3.0-fold increased risk of chronic depressive symptoms (Wald 95% CI 1.27-7.26), 2.3-fold increased risk of incident depression (95% Wald CI 1.08-5.13) and 2.0-fold increase of incident anxiety (Wald 95% CI 0.78-5.00). Depression and anxiety were slightly more common in Hormone Therapy users after RRBSO vs non-users. CONCLUSIONS: RRBSO leads to a rapid increase in clinically significant depressive and anxiety symptoms despite Hormone Therapy use.

Knowledge and awareness toward menopause and hormone therapy among premenopausal women in Jordan.

BACKGROUND: Menopause is a natural important transition in women's life. Having adequate knowledge and perception about menopause at a young age is critical for women to cope better with its associated consequences and improve their well-being. OBJECTIVE: This study evaluated the awareness, knowledge, and perception of menopause and menopause hormone therapy (MHT) among premenopausal females from Jordan. METHODS: A cross-sectional study including females aged 20-40 years (n = 450) was conducted from November 2018 to March 2019 in two hospitals in Irbid, Jordan. A structured questionnaire was developed based on previous literature and using the Green Climacteric Scale to assess participants' knowledge and awareness of signs and symptoms of menopause and MHT. Data were collected by face-to-face interview. Factors associated with the degree of menopausal knowledge were identified. RESULTS: The mean ± standard deviation age of participants was 29.1 ± 6.3 years. More than half of participants were knowledgeable about several aspects of menopause. Education to college or more was significantly and positively associated with knowledge about menopause (ß = 0.504, p = 0.005). The majority of participants did not know the roles, benefits, and risks of MHT. There was an almost equal distribution for participants' positive (47.6%) and negative (50%) attitudes toward menopause. CONCLUSIONS: The findings suggest that premenopausal females in Jordan are knowledgeable about various aspects of menopause. Nevertheless, there is still a need to develop educational programs and implement proper counseling to improve young females' awareness about menopause, particularly its health implications and treatment options.

A potential association of meditation with menopausal symptoms and blood chemistry in healthy women: A pilot cross-sectional study.

Owing to hormonal changes, women experience various psychophysiological alterations over a wide age range, which may result in decreased quality of life as well as in increased risks of diseases, such as cardiovascular diseases. Although studies have been performed to research complementary methods, such as meditation, the research field still requires an adequate amount of studies for public health guidelines. This pilot cross-sectional study aims to investigate a potential association of meditation with menopausal symptoms and blood chemistry for healthy women. In this study, data of 65 healthy women (age range 25-67) including 33 meditation practitioners and 32 meditation-naïve controls were analyzed to compare the Menopausal Rating Scale scores and blood chemistry with 7 more dropouts in the blood chemistry. For blood chemistry, nine components including glucose (GLU) and high-density lipoprotein cholesterol (HDL) were measured. Two-way analysis of variance was performed by dividing the total participants into 2 groups: premenopausal and postmenopausal participants. Compared to the control group, the meditation group showed a trend of reductions in the Menopausal Rating Scale total score (P = .054) and its 2 subcomponents: depressive mood (P = .064) and irritability (P = .061). In HDL level, there was a significant interaction between group and menopausal state (P = .039) with following post hoc results: among the premenopausal participants, a significant increase in the meditation group compared to the control group (P = .005); among the control group, a significant increase in the postmenopausal compared to the premenopausal participants (P = .030). In GLU level, there was a mild interaction between group and menopausal state (P = .070) with following post hoc results: among the postmenopausal participants, a trend of increase in the control group compared to the meditation group (P = .081); among the control group, a significant increase in the postmenopausal compared to the premenopausal participants (P = .040). Our research suggests a potential association of practicing meditation with alleviations in menopausal symptoms and changes in blood chemistry, warranting further studies with a longitudinal study design and larger populations to understand the underlying causal relationships.

Effects of dehydroepiandrosterone on quality of life in premenopausal women with rheumatoid arthritis: A preliminary randomized clinical trial.

AIM: Chronic inflammation and subsequent use of glucocorticoids can lead to relative adrenocortical insufficiency in patients with rheumatoid arthritis (RA). Previously, adrenocortical hormone, dehydroepiandrosterone (DHEA) was shown as a potential therapy for autoimmune disorders. However, data regarding effects of DHEA in RA are limited. The aim of this study was to investigate the effects of DHEA on quality of life (QOL) in premenopausal rheumatoid arthritis patients. METHOD: In this randomized double blinded, controlled trial 46 premenopausal rheumatoid arthritis patients were assigned to receive 50 mg/d DHEA (23 patients) or placebo (23 patients) for 12 weeks. Disease Activity Score of 28 joints - erythrocyte sedimentation rate (DAS28-ESR) questionnaire, visual analog score and swollen and tender joint counts (both 0-28) were used for assessment of disease activity. Persian-validated World Health Organization Quality of Life Brief version (WHOQOL BREF) questionnaire was used to assess quality of life. RESULTS: In comparison to the control group more improvement in QOL (P = .025) and environment health (P = .001) was observed in the DHEA group. After adjustment for age and disease duration DHEA was associated with more improvement in QOL (P = .01), psychological (P = .02) and physical health (P = .03). A trend toward a decrease in ESR was observed in DHEA group (P = .06). DAS was improved in both groups; however, there was no significant change in DAS28 between groups (P = .88). Frequency of adverse events albeit minor was similar in both groups. CONCLUSION: Our study supports a slightly superior effect of DHEA over placebo to improve QOL in premenopausal female patients with rheumatoid arthritis. We did not find improvement in DAS in the DHEA group over placebo.

Psychosocial aspects and life project disruption in young women diagnosed with metastatic hormone-sensitive HER2-negative breast cancer.

Metastatic breast cancer (MBC) diagnosis in young women negatively impacts on quality of life (QoL) and daily activities, disrupting their life project and forcing them to face new psychosocial challenges. The recently published results on the improvement of the overall survival of pre- or perimenopausal women with hormone-receptor-positive, HER2-negative MBC treated with CDK4/6 inhibitors plus endocrine therapy, while preserving, and in some items improving their QoL, will change the landscape of the management of this patient population. Their extended survival and potential improvement in QoL will, therefore, modify their specific needs in terms of psychosocial support. The complexity of the care of young women with MBC is described herein, based on an extensive literature review. Further research about the specific psychosocial requirements of these women and a new multidisciplinary holistic approach is paramount to properly address their concerns and preferences. The communication with and support of their partners, parents and children is an important factor affecting the QoL of these patients. Altogether, a multidisciplinary care, open communication and personalized support is required to address the psychosocial implications of the new prognostic expectations on these patients with the incorporation of new targeted therapies.

Postmenopausal women with irritable bowel syndrome (IBS) have more severe symptoms than premenopausal women with IBS.

BACKGROUND: Although irritable bowel syndrome (IBS) is more common in women, little is known about the role of hormonal changes and menopause in IBS. This study aimed to evaluate for differences in gastrointestinal (GI) and psychological symptoms between pre- and postmenopausal women with IBS compared to age-matched men with IBS. METHODS: Patients with Rome-positive IBS were identified. Premenopausal women were <45 years of age with regular menses. Postmenopausal women were ≥45 years without menses for at least 1 year. Younger men were <45 years, and older men were ≥45 years. Questionnaires measured severity of IBS symptoms, somatic symptoms, health-related quality of life (HRQOL), and psychological symptoms. Multivariable linear or logistic regressions evaluating relationships between age and sex were performed. KEY RESULTS: 190 premenopausal women (mean age 30.25 years), 52 postmenopausal women (mean age 54.38 years), 190 men <45 years (mean age 30.45 years), and 52 men ≥45 years (mean age 53.37 years) were included. Postmenopausal IBS women had greater severity of IBS symptoms (P = .003) and worse physical HRQOL (P = .048) compared to premenopausal women. No differences were observed between age-matched older and younger IBS men. Constipation increased with age for both sexes but was the principal IBS subtype in women only. CONCLUSIONS AND INFERENCES: Postmenopausal women with IBS have more severe IBS symptoms than premenopausal women, while no comparable age-related changes were seen in IBS men. The modulatory effect of female sex hormones on brain-gut interactions which affect visceral perception and GI function likely contributes to these findings.

Concomitants of menopause-specific quality of life in premenopausal and post-menopausal women living in South Korea.

The present study investigated the concomitants of menopause-specific quality of life among premenopausal and postmenopausal women. Based on the Wilson and Cleary model of quality of life, this cross-sectional study recruited 329 women of age 40-65 years following operational convenience. The study was conducted in the office of the Korea Population, Health and Welfare Association (KPHWA) in Incheon, South Korea. Data collected on sociodemographic characteristics, social support, biological/physiological characteristics, the Pittsburgh Sleep Quality Index (PSQI-K), and self-rated health. Menopause-specific quality of life questionnaire (MENQOL) was used in this study. Hierarchical multiple linear regression analysis was performed. The study found that social support and self-rated health were negatively correlated with MENQOL in premenopausal women, while the income level and self-rated health were negatively associated with MENQOL in postmenopausal women. Sleep quality was positively correlated with MENQOL in both premenopausal and postmenopausal women. The study results indicate the need for tailored approaches based on menopausal status. Especially, social support may help improve the MENQOL of premenopausal women, while in postmenopausal women, improved sleep quality may enhance their menopause-specific quality of life.

Mild sleep restriction increases 24-hour ambulatory blood pressure in premenopausal women with no indication of mediation by psychological effects.

BACKGROUND: Studies assessing the impact of sleep restriction (SR) on blood pressure (BP) are limited by short study length, extreme SR (<4 hours a night), and lack of attention to psychological distress as a possible mediator. METHODS: A community-based cohort was assembled with 237 women (age 34.1 ±â€¯13.5 years; body mass index 25.4 ±â€¯5.4 kg/m2), and a randomized, crossover, intervention study was conducted in 41 women (24 completed: age 30.2 ±â€¯6.5 years; body mass index 24.3 ±â€¯2.8 kg/m2) to determine the causal effect of SR on BP. Sleep was maintained as usual (HS) or reduced by 1.5 hours a night (SR) for 6 weeks. In the cohort, associations between sleep and psychosocial factors were evaluated using multivariable models adjusted for demographic and clinical confounders. In the intervention study, in-office BP was measured weekly; ambulatory BP was measured at end point. Psychological factors were assessed at baseline and end point. Mixed-model analyses with total sleep time (TST, main predictor), week and fraction of time spent in physical activity (covariates), and subject (random effect) were performed. RESULTS: Among the community cohort, higher perceived stress, stressful events and distress, and lower resilience were associated with shorter sleep, worse sleep quality, and greater insomnia symptoms (P < .05). In the intervention, systolic BP increased as TST decreased (TST × week interaction, [coefficient ±â€¯standard error] -0.0097 ±â€¯0.0046, P = .036). Wake ambulatory diastolic blood pressure (-0.059 ±â€¯0.022, P = .021) and mean arterial pressure (-0.067 ±â€¯0.023, P = .018) were higher after SR versus HS. Psychological distress variables were not affected by TST and did not mediate the effects of SR on BP. CONCLUSIONS: These results suggest that SR influences CVD risk in women via mechanisms independent of psychological stressors.

Effectiveness of transdermal nicotine patch in premenopausal female smokers is moderated by within-subject severity of negative affect and physical symptoms.

RATIONALE: Nicotine patches may be less effective in female compared with male smokers. However, it is unknown if negative affect and physical symptoms influence transdermal nicotine patch-related effects on smoking behaviors. METHODS: Eighty-one acutely tobacco-abstinent premenopausal female smokers attended three counter-balanced experimental sessions across the menstrual cycle (early follicular, late follicular, and mid-luteal) and were randomized to patch condition (nicotine [21 mg] vs. placebo [0 mg] transdermal patch). Negative affect and physical symptoms were assessed prior to patch administration. The patch was removed 5 h post-administration, and participants completed a smoking reinstatement task. Multilevel linear models tested associations of patch condition, negative affect and physical symptoms, and their interaction on smoking behavior. RESULTS: There was a significant patch condition × Negative Affect and Pain symptoms interaction on the number of cigarettes smoked (p < 0.05). When Negative Affect and Pain were lower-than-usual, females administered a nicotine patch smoked significantly fewer cigarettes than females administered a placebo patch (p < .05), but there were no significant patch differences when Negative Affect and Pain were higher-than-usual. There was also a significant patch condition × Negative Affect interaction on time delay. The effects of patch condition on time delay to smoking were greater during sessions in which Negative Affect was higher-than-usual. CONCLUSIONS: Results suggest that among female smokers transdermal nicotine patch effectiveness may interact with negative affect and pain. Understanding and considering female-specific factors that may impact the efficacy of one of the most commonly used cessation medications is important for improving smoking cessation in female smokers.

The role of physical activity in the link between menopausal status and mental well-being.

OBJECTIVE: To examine the relationship between menopausal status and mental well-being, and whether this relationship varies as a function of physical activity (PA). METHODS: Based on a hormonal analysis and bleeding diary, women aged 47 to 55 were categorized as pre (n = 304), early peri (n = 198), late peri (n = 209), or postmenopausal (n = 387). Mental well-being was assessed using the Centre for Epidemiologic Studies Depression Scale, the International Positive and Negative Affect Schedule Short Form, and the Satisfaction with Life Scale. PA was self-reported and categorized as low, medium, and high. Associations between variables were analyzed using multivariate linear regression adjusted for age, marital and employment status, parity, self-reported mental disorder, use of psycholeptics and psychoanaleptics, and menopausal symptoms. RESULTS: Depressive symptoms were lower amongst the pre than postmenopausal women (B = 0.07, confidence interval 0.01-0.13). Menopausal symptoms attenuated these associations. Menopausal status showed no associations with life satisfaction, or with positive or negative affectivity.Women with high PA scored higher on positive affectivity, and the pre, early peri, and postmenopausal women scored higher on life satisfaction (B = 0.79, P < 0.001; B = 0.63, P = 0.009; B = 0.42, P = 0.009, respectively) and scored lower on depressive symptoms (B = -0.13, P = 0.039; B = -0.18, P = 0.034; and B = -0.20, P < 0.001, respectively) than their low PA counterparts. The pre and postmenopausal women with medium PA scored higher on life satisfaction (B = 0.54, P = 0.001; B = 0.038, P = 0.004, respectively) than those with low PA. CONCLUSIONS: Postmenopausal women reported marginally higher depressive symptoms scores compared with premenopausal women, but menopause was not associated with positive mental well-being. However, this association varies with the level of PA. : Video Summary:http://links.lww.com/MENO/A520.

Morning chronotype is a protective factor against chemotherapy-induced hot flashes in premenopausal women with breast cancer.

PURPOSE: Adjuvant chemotherapy in patients with breast cancer often causes hot flashes, impairing quality of life. However, the chronobiological or psychiatric factors associated with the development of chemotherapy-induced hot flashes (CIHFs) remain undetermined. The purpose of this study was to investigate whether chronotype was associated with the incidence of CIHFs. METHODS: A total of 119 premenopausal women with non-metastatic breast cancer awaiting adjuvant chemotherapy after surgery without hot flashes were included. The presence of CIHF was defined as having moderate to severe hot flashes, as measured by the subscale of hot flashes in the Menopause Rating Scale, at 4 weeks after the completion of chemotherapy. Chronotype (Morning/Intermediate/Evening) was assessed with the Composite Scale of Morningness before adjuvant chemotherapy. To examine the association between chronotype and CIHF, we built logistic regression models, adjusting for age, body mass index, sleep quality, and radiation therapy. RESULTS: CIHF occurred in 50.4% of participants. Morning type was inversely associated with CIHF (reference: Intermediate type, odds ratio [OR], 0.37; 95% confidence interval [CI], 0.16-0.94; p = 0.040) in the univariate model, and the association remained significant (OR, 0.37; CI, 0.13-0.96; p = 0.045) after adjusting for age, body mass index, sleep quality, and radiation therapy. CONCLUSIONS: Morning chronotype is a protective factor against the development of CIHF in patients with breast cancer. Chronotypes should be assessed and considered in the prediction and management of CIHF.

Associations of dietary trans fatty acid intake with depressive symptoms in midlife women.

BACKGROUND: To study the association of trans fatty acid intake from diet with depressive symptoms in midlife women. METHODS: Data for this cross-sectional study were retrieved from baseline assessment of the Study of Women's Health Across the Nation (SWAN). Linear regression, logistic regression and restricted cubic spline models were performed to examine the association trans fatty acid intake with depressive symptoms. RESULTS: A total of 3095 women aged 42-52 years were included in the present study. Trans fatty acid intake was positively associated with CES-D (Center for Epidemiological Studies-Depression) scores in unadjusted, age-, race/ethnicity-, total family income- and education-adjusted and fully adjusted linear regression model. The fully adjusted regression coefficient with 95% confidence intervals (CIs) of trans fatty acid intake were 0.146 (0.047-0.246) for CES-D score. Trans fatty acid intake was positively associated with depressive symptoms (CES-D score ≥16) in each logistic regression model. The fully adjusted odds ratios (ORs) with 95% CI of depressive symptoms were 1.410 (1.019-1.951) in quartile 4 compared with quartile 1 for trans fatty acid intake. Sensitivity analyses showed that the association between trans fatty acid and depressive symptoms were not affected by use of antidepressant. Stratified analysis showed that, in fully adjusted model, the trans fatty acid intake was not significantly associated with depressive symptoms in early perimenopausal women. LIMITATIONS: This was a cross-sectional study, limiting causal inferences. CONCLUSION: Trans fatty acid may be positively associated with depressive symptoms in premenopausal women, but not in early perimenopausal women.

Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.

OBJECTIVE: To evaluate the safety and efficacy of bremelanotide for the treatment of premenopausal women with hypoactive sexual desire disorder. METHODS: Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder. Patients were randomized 1:1 to 24 weeks of treatment with bremelanotide or placebo. Sample size was estimated based on simulations from key endpoints in patients with hypoactive sexual desire disorder from a prior trial. Coprimary efficacy endpoints were change from baseline to end-of-study in the Female Sexual Function Index-desire domain score and Female Sexual Distress Scale-Desire/Arousal/Orgasm item 13. RESULTS: Study 301 began on January 7, 2015, and concluded on July 26, 2016. Study 302 began on January 28, 2015, and concluded on August 4, 2016. Of the 1,267 women randomized, 1,247 and 1,202 were in the safety and efficacy (modified intent-to-treat) populations, respectively. Most participants were white (85.6%), from U.S. sites (96.6%), and had a mean age of 39 years. From baseline to end-of-study, women taking bremelanotide had statistically significant increases in sexual desire (study 301: 0.30, P<.001; study 302: 0.42, P<.001; integrated studies 0.35, P<.001) and statistically significant reductions in distress related to low sexual desire (study 301: -0.37, P<.001; study 302: -0.29, P=.005; integrated studies -0.33, P<.001) compared with placebo. Patients taking bremelanotide experienced more nausea, flushing, and headache (10% or more in both studies) compared with placebo. CONCLUSIONS: Both studies demonstrated that bremelanotide significantly improved sexual desire and related distress in premenopausal women with hypoactive sexual desire disorder. The safety profile was favorable. Most treatment-emergent adverse events were related to tolerability and the majority were mild or moderate in intensity. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02333071 (study 301) and NCT02338960 (study 302). FUNDING SOURCE: Palatin Technologies, Inc., and AMAG Pharmaceuticals, Inc.

Ovarian remnant syndrome in an aromatase inhibitor-treated patient with BRCA2 mutation following bilateral oophorectomy.

Ovarian remnant syndrome (ORS), in which a portion of the ovary is retained following bilateral salpingo-oophorectomy (BSO), is uncommon but can negatively impact patient management. Evaluation should be performed in a patient who has clinical signs or symptoms suggestive of ORS, especially in a premenopausal woman with breast cancer who is treated with an aromatase inhibitor following bilateral salpingo-oophorectomy (BSO), or a woman with a pathogenic variant in BRCA1 or BRCA2 who undergoes BSO for ovarian cancer risk reduction.

Assessment of quality of life (QoL) in breast cancer patients by using EORTC QLQ-C30 and BR-23 questionnaires: A tertiary care center survey in the western region of Saudi Arabia.

This cross-sectional study is aimed at assessing the quality of life in a cohort of breast cancer patients at the Oncology Department, King Abdulaziz University Hospital (KAUH), King Abdulaziz University (KAU), Jeddah, Saudi Arabia (SA), and to differentiate QoL among different groups. Mean time since diagnosis was 3.97±1.90 years. European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 and BR23 (EORTC QLQ-C30 & BR23) were used to assess QoL in breast cancer survivors. ANOVA and independent t-test (parametric tests) were used for the categorical variables and Kruskal-Wallis and Mann-Whitney tests used for non-parametric tests. Linear regression analysis was done to measure predictors' significance and to calculate the coefficient of determination. Two hundred and eighty-four patients completed the survey. Global health status and functional scales, in most of the domains, were high, while symptom scales were moderate-to-low for most items, showing better QoL. Insomnia and fatigue were the most disturbing symptoms. Patients exhibited higher scores for body image and future perspective, while the least score is for sexual functioning. Global health, physical functioning, and role functioning were better in the age group ≤50 years (p<0.05). Premenopausal and perimenopausal patients showed a better level of functioning as compared to postmenopausal patients (p = 0.001). Premenopausal patients scored higher for sexual enjoyment, as compared to peri- and post-menopausal patients (p = 0.04). Systemic therapy side effects were more evident in the breast conservative surgery group. Predictors explained 8% of the variation in Physical functioning (R-squared = 0.08). A predictor that had a remarkable influence on physical functioning, as compared to the other predictors in the model, was menopausal status (P = 0.02). So, it was concluded that the breast cancer patients visiting our institute had a better quality of life regarding overall global health status as well as functional and symptom scales. Some issues, for instance, fatigue, insomnia, hair loss, and others, warrant good supportive therapy.