Clinical Research Directory

Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation

Atherosclerotic coronary artery disease (CAD) is a leading cause of mortality among postmenopausal women. Resveratrol, a phenolic compound with antioxidant properties, may influence lipid metabolism, endothelial function, and platelet aggregation, while sirtuin-1 and sirtuin-3 regulate metabolic and hormonal responses to nutritional stimuli. This randomized, double-blind, placebo-controlled trial evaluates the effects of trans-resveratrol supplementation (1000 mg/day) versus placebo, over 90 days, on serum estradiol and estrone levels, gene expression of estrogen receptors alpha and beta, and sirtuins 1 and 3 in 80 postmenopausal women with CAD. Findings may inform therapeutic strategies for postmenopausal women with chronic coronary disease.

Depression, Aging, Stress and Heart Health Study

Depression is a known risk factor for cardiovascular disease (CVD), and this comorbidity contributes significantly to the morbidity and mortality of women. The menopausal transition or perimenopause is a period of vulnerability for both depression and CVD, making it a key time to study this critical public health issue. This research will preliminarily explore whether disruption in two novel stress pathways 1) the renin-angiotensin-aldosterone system (RAAS) and autonomic nervous system (ANS) and their relationship may underlie the link between these illnesses. Findings will provide important insight into potential mechanisms by which depression during perimenopause may increase risk for CVD in midlife women, which will inform potential risk reduction and treatment strategies that can improve health outcomes in this population.

Role of Menopause in Thermoregulation

The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men. Aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.

Brazilian Registry of Menopausal Health

The Brazilian Registry of Menopausal Health is a national study aimed to better understand the health and quality of life of participants aged 35 to 65 who are in the menopausal transition or postmenopausal phase, including cisgender women and transgender men. The study's hypothesis is that significant regional and socioeconomic disparities influence individuals' health, knowledge, and perception of menopause.

Cuidar-ME, a Web-based Psychological Intervention for (Peri)Menopausal Women: A Pilot Randomized Controlled Trial

The Cuidar-ME program is a web-based cognitive-behavioral intervention designed to promote well-being and mental health in women during (peri)menopause. The main goal of this research is to evaluate its acceptability, feasibility and preliminary evidence of efficacy of the intervention. This pilot randomized controlled trial uses a two-arm design and serves as a preliminary step before a full-scale RCT. A sample of at least 150 (peri)menopausal women, aged 40 to 60, will be recruited online. Participants who meet the eligibility criteria will be randomly assigned to either the web-based intervention (Cuidar-ME) or a waitlist control condition (which will receive access to the program after the study concludes). Participation in this study will last approximately 3 months. Participants in both conditions will be invited by the researchers via email to complete baseline and post-intervention assessments. These assessments will include self-report questionnaires evaluating several outcomes (e.g., quality of life, menopausal symptoms, depressive and anxiety symptoms, menopause representations, etc.), potential mechanisms of treatment response (emotional regulation and self-compassion), as well as user acceptability and feasibility.

Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause

Hypoactive sexual desire disorder (HSDD) is described as the most common form of female sexual dysfunction, particularly affecting peri- and postmenopausal women and is associated with significant distress and reduced quality of life. The TESTA-MIND study will evaluate the efficacy and safety of a standardized compounded transdermal testosterone gel in a randomized, double-blind, placebo-controlled design to address the lack of FDA-approved options and limited high-quality evidence for treating decreased libido in women.

Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women

The menopausal transition is associated with significant hormonal changes that negatively impact many women's quality of life. Vasomotor symptoms, sleep disturbances, mood changes, and genitourinary symptoms are frequently reported during this period. Concurrently, there is a tendency toward increased body weight and fat redistribution, specifically central fat accumulation, which raises the risk of metabolic diseases. Although hormonal therapy is effective, it is not suitable for all women, necessitating the consideration of non-pharmacological strategies as therapeutic alternatives. Scientific evidence indicates that healthy dietary patterns and weight loss are associated with reduced menopausal symptom severity. The objective of the research is to evaluate the effects of a dietary intervention based on the guidelines of the Dietary Guidelines for the Brazilian Population (GAPB) on the reduction of menopausal symptoms. A randomized clinical trial will be conducted to assess whether improving dietary quality and reducing body weight contribute to alleviating menopausal symptoms. Participants will be assigned to two groups: a control group (CG) and an intervention group (IG). Both groups will receive nutritional guidance based on the GAPB; however, the CG will receive the guidelines in printed format, whereas the IG will receive them through group sessions. The study will include perimenopausal or postmenopausal women who are overweight or obese and experiencing menopausal symptoms. Validated instruments will be administered at the beginning and end of the study to assess dietary patterns, menopausal symptoms, and nutritional status.

The Influence of the "Washoku" Diet on the Gut Microbiota in Postmenopausal Women

Menopause is a special period in a woman's life, when a sudden drop in estrogen levels leads to the cessation of menstrual cycles. Hormonal changes and a decreasing metabolic rate contribute to weight gain and the appearance of numerous metabolic disorders, such as dyslipidemia, impaired glucose tolerance, insulin resistance, hyperinsulinemia, and type 2 diabetes. Currently, effective and inexpensive dietary therapeutic solutions are being sought to improve the health of this group of women. It is suggested that the Japanese washoku diet, which includes products rich in isoflavones, fiber (soy products) and unsaturated omega-3 fatty acids (fish, seaweed), may be a good solution, as it contributes to the regulation of hormonal balance, lowering cholesterol levels, and reducing the risk of insulin resistance. Moreover, the composition of such a diet may also affect the diversity of the intestinal microbiota and the production of its metabolites, such as short-chain fatty acids, and thus contribute to the improvement of patients' health. Taking the above into account, the aim of the study will be to assess the effect of the Japanese washoku diet on the composition of the intestinal microbiota and its metabolites in a group of overweight or obese women after natural menopause. Specific objectives: * Assessment of anthropometric parameters (body weight, height, waist circumference, hip circumference) and body composition and bone density. * Assessment of parameters of carbohydrate metabolism (glucose, insulin concentration), lipid metabolism (total cholesterol (T-C), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), non-HDL cholesterol (non-HDL-C) and triglycerides). * Analysis of intestinal microbiota, short-chain fatty acids in the feces of women.

Cyclic vs. Constant Estradiol: Regimens' Effects on Brain Health

The purpose of this study is to learn more about how estradiol patch treatment affects brain processes, health, and wellbeing.

Effects of Strength Training on the Gait and Pelvic Floor in Menopausal Women

The overall objective will be to observe whether a strength and balance training intervention produces significant changes in the analysis of double stance phase movement during gait, the analysis of coxofemoral, tibial and calcaneal joint movement during gait, pelvic floor contractile activity in standing and monopodal stability, stress urinary incontinence, fracture risk, sexual function and prolapse in sedentary menopausal women in the short and medium term.

VEDA Study (DHEA vs Estradiol)

This study is being done to compare two vaginal treatments, vaginal estrogen and vaginal DHEA, that are used to treat vaginal and urinary symptoms related to menopause. These symptoms may include vaginal dryness, discomfort, painful intercourse, or urinary problems and can affect quality of life and sexual health. Women who choose to participate will be randomly assigned to use one of the two treatments for a set period of time. Participants will complete questionnaires about their symptoms and sexual health and have simple vaginal testing at the beginning and end of the study. The goal of this research is to better understand how these treatments affect vaginal health and sexual function so healthcare providers can make informed treatment decisions and improve care for postmenopausal women.

Effects of a Mobile Game in Menopausal Women

The goal of this clinical trial is to evaluate the effect of a mobile game-based cognitive intervention on brain fog and psychological well-being in menopausal women aged 45-55 years. The main questions it aims to answer are: Are Brain Fog Scale scores lower among women in the mobile game intervention group compared with women in the control group? Are Warwick-Edinburgh Mental Well-Being Scale scores higher among women in the mobile game intervention group compared with women in the control group? Do women participating in the mobile game intervention demonstrate greater reductions in Brain Fog Scale scores and greater improvements in Warwick-Edinburgh Mental Well-Being Scale scores after the intervention compared with their baseline measurements? Researchers will compare participants receiving the mobile game-based cognitive intervention with participants receiving routine follow-up only to determine the effectiveness of the intervention on brain fog and psychological well-being. Participants will: Complete baseline assessments using the Brain Fog Scale and the Warwick-Edinburgh Mental Well-Being Scale. Be randomly assigned to either the intervention group or the control group. Use the cognitive training mobile game for 15 minutes per day, 5 days per week, for 6 weeks if assigned to the intervention group. Receive routine follow-up only if assigned to the control group. Complete post-intervention assessments at the end of the 6-week study period.

Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women

This proof-of-concept, open-label, single-arm study is designed to evaluate the effects of daily consumption of Haelan 951, a fermented soy conventional food product, on self-reported menopausal vasomotor symptoms, sleep quality, and health-related quality of life in peri- and postmenopausal women. The study will collect descriptive data on participant-reported outcomes over the study period to assess the feasibility and potential effects of Haelan 951 in supporting menopausal wellness. The study is not intended to evaluate the treatment, prevention, or cure of any disease.

Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia

The purpose of this study is to examine hypoxic vasodilation and the role of beta-adrenergic receptors in younger premenopausal, perimenopausal, and older postmenopausal women.

Improving Functioning Among Aging Women Veterans

Women are the fastest-growing group of U.S. Veterans. Over half of those using VA care are 45 or older, with more age-related health concerns than civilian women. The VA urgently needs gender-informed strategies to ensure women Veterans receive tailored care that addresses their intersecting mental, physical, and age related health concerns, as well as gender-linked stressors. One prominent example is menopause, a health transition period that, for many women, can be associated with negative physical and mental health concerns that can worsen their functioning and quality of life. This project will: (1) integrate stakeholder feedback to tailor Cognitive Behavioral Therapy for Menopause (CBT-Meno) for women Veterans with menopause concerns; and (2) refine and evaluate tailored CBT-Meno as a treatment to address these intersecting needs in a clinical trial.

A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects

The two products used in this study are transdermal patches that contain selegiline. The test drug is the Estradiol/Levonorgestrel Transdermal Delivery System (TDS). The comparator drug is the Climara Pro® TDS. The purpose of this research study is to compare how the skin tolerates the test TDS and the comparator TDS. The study will evaluate and compare skin irritation and possible allergic-type skin reactions (sensitization) caused by the two products. The comparison will be based on how the skin responds to repeated applications of each TDS. This includes the assessment of skin irritation during the Induction Period and the evaluation of possible allergic or sensitization reactions after the Challenge Period. In addition, the adhesion of each patch (how well the patch sticks to the skin over time) will be regularly checked, as this is important for both product performance and skin safety.

Beta3-adrenergic Receptors and Cardiovascular Function in Aging Women

To determine if vascular beta3 adrenergic receptors are present and functional in aging women and can be targeted to attenuate sympathetic vasoconstriction and enhance vascular function in aging women.

DBPCT Effects of Omega-3 FA on Memory and Cognition in Peri- and Menopausal Women

The goal of this clinical trial is to learn if daily omega-3 supplementation improves memory and cognitive function in perimenopausal and menopausal women aged 40-60 years. It will also assess whether omega-3 supplements influence menopausal symptoms, stress levels, and sleep patterns. The main questions it aims to answer are: 1. -Does omega-3 supplementation improve memory and cognitive performance? 2. \- Does omega-3 supplementation affect menopausal symptoms, stress, and perceived memory changes? 3- Are there any differences in sleep patterns during supplementation? Researchers will compare omega-3 supplements to a placebo to see if omega-3 improves memory and cognition.

Foot and Ankle Strengthening Program to Improve Physical Function in Menopausal Women (FAMEX)

This randomized controlled trial will evaluate the effects of a 12-week foot and ankle strengthening program on physical function and health-related quality of life in menopausal women. Menopause is associated with hormonal changes that may negatively affect muscle strength, balance, and functional capacity, potentially leading to reduced mobility and increased risk of falls. Although exercise interventions have demonstrated benefits in this population, most programs focus on global lower-limb training and rarely target the foot and ankle complex, which plays a key role in postural stability and gait propulsion. Approximately 60 menopausal women aged 45-65 years will be randomly assigned to either an intervention group performing a structured foot and ankle strengthening program or a control group maintaining their usual physical activity. The intervention will last 12 weeks and will include one supervised weekly session and four home-based sessions. The primary outcome will be ankle plantarflexion isometric strength measured by hand-held dynamometry. Secondary outcomes will include ankle strength in other directions, intrinsic foot muscle function, gait speed, spatiotemporal gait parameters, balance, foot-related functional status, and health-related quality of life.

Menopausal Hormone Therapy And Left Ventricular Function

The purpose of this study is to compare left ventricular stroke volume and heart rate responses to bursts of SNA between PMF using, and not using, MHT.

Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women

This study tests the feasibility and acceptability of Waning Moon, a culturally tailored menopause health intervention developed in partnership with the Urban Indian Center of Salt Lake (UICSL) for American Indian/Alaska Native (AI/AN) women. Waning Moon is a 4-session integrative medical group visit program delivered by community health workers and prescribing providers. It covers menopause education, complementary health approaches, and community support. Thirty midlife AI/AN women will participate. The study will assess whether the program is feasible to deliver and acceptable to participants and clinical partners.

The Effects of Fractal Mindfulness Virtual Reality on Menopause Symptoms

The study aimed to establish the effectiveness of an immersive mindfulness virtual reality intervention using fractal software for women experiencing menopausal symptoms. It was hypothesised that post immersive virtual reality fractal mindfulness intervention would result in higher levels of sexual function, wellbeing and cognitive mindfulness with lower levels of menopause symptoms. It was further hypothesised that in physiological responses, the pulse rate would be lower post intervention per session and an overall reduction in pulse rate post intervention. An electroencephalogram will be used to monitor alpha and beta ratios.

Inflammation, Autoimmunity and Healthy Ageing in Menopause Transition. An Observational, Cross-sectional Study

The goal of this observational study is to investigate the prevalence of autoimmune or immune-mediated conditions in women during the menopausal transition (aged 40-60 years). The main questions it aims to answer are: * What is the prevalence of autoimmune or immune-mediated conditions in women aged 40-60 years across different reproductive stages? * How do inflammatory markers, resilience, lifestyle factors, and allostatic load scores relate to menopause-related symptoms and general health? Participants will complete evaluations, provide samples for clinical, immunological, and biochemical markers, and undergo assessments to analyze symptom burden and psychosocial determinants during the menopausal transition.

Chinese Herbal Sachet Therapy for Sleep Quality in Menopausal Women

Many women sleep poorly during the menopausal transition. Some prefer not to take hormone therapy or sleeping tablets, and ask their nurses about other options. This study tested a traditional Chinese medicine aromatic sachet containing ten herbs, chosen by a panel of experts. Women placed the sachet beside their pillow each night for nine weeks and removed it each morning. One hundred and twenty-two women aged 45 to 59 who reported poor sleep and were recruited in Macao took part. Half received the herbal sachet and half received a placebo sachet, which was identical in appearance, weight and packaging and carried a herbal scent, but did not contain the herbs being tested. Participants were not told which sachet they had been given. Sleep quality was measured using the Pittsburgh Sleep Quality Index at the start of the study and again after 3, 6 and 9 weeks.