Clinical Research Directory

The Synergistic Effects of Menopause and HIV on Cardiovascular Disease Risk in Women

Menopause is associated with the acceleration of many comorbidities, including cardiovascular disease. Whether HIV and menopause together increase cardiovascular disease risk is a key knowledge gap. The goal of this observational study is to address this knowledge gap by looking at the role of menopause on cardiovascular disease risk factors such as insulin resistance, hypertension, hyperlipidemia, and carotid atherosclerosis using previously collected data. The investigators will look at underlying causes for cardiovascular diseases worsening in menopausal women with HIV by looking at the role of increased inflammation in the body and whether this is altered by weight. The investigators achieve this by enrolling participants who are willing to undergo a whole body MRI.

Menopausal HT for Women Living With HIV (HoT)

Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV. This trial is being done to see if: * There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV * Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV * Hormone therapy is safe and tolerable for women living with HIV

Intra Ovarian Muse Cell Injection for Perimenopause Symptom Relief and Ovarian Function Restoration (MUSE-OVARY)

This observational study examines the safety and effects of injecting Muse cells (a type of naturally occurring stem like cells found in adult tissues such as fat or bone marrow) directly into the ovaries of women aged 28 to 70 who are going through peri-menopause. Perimenopause is the transition time before menopause when hormone levels fluctuate, periods become irregular, and many women experience symptoms like hot flashes, night sweats, sleep problems, mood changes, and reduced energy. Current treatments mainly manage symptoms but do not restore natural ovarian function. Muse cells have special properties: they can help repair tissues, reduce inflammation, support cell energy production, and promote a healthier environment in the ovaries. In this study, women who choose to receive ultrasound guided Muse cell injections into their ovaries as part of their own regenerative care will be carefully followed. Researchers will monitor safety, hormone levels (such as FSH, estrogen, and AMH), ovarian follicle counts via ultrasound, menstrual patterns, and quality of life improvements using questionnaires. The study does not assign treatment - participants and their doctors decide on the procedure, and information is collected in a standardized way over 24 months (with longer safety follow-up). The goal is to gather real world data on whether this approach can help stabilize hormones and support ovarian tissue during perimenopause. No placebos or experimental drugs are used in this observational study.

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.

Menopause Effects on Cortico-reticular Functioning

Post-menopausal women who request to begin hormone-replacement therapy (HRT) are directed to the research team. The participants are tested before beginning HRT, after two months of HRT, and five months of HRT. Tests include strength performance, central nervous system functioning, body composition, resting metabolic rate, and vascular screening. The participants are provided a 12-week training intervention (2 x strength, 2 x endurance per week) that can be voluntarily followed between tests at month 2 and 5. Compliance with the training program is recorded. A minimum of 15 participants are needed a priori, but the investigators aim to recruit and test 20 women.

Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training

The purpose of this research is to understand how training the muscles used for breathing (inhalation) affects menopausal hot flashes, sympathetic nerve activity and sleep.

The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health.

The aim of this clinical trial is to determine if resistance training and a newly developed plant-based nutritional supplement can improve the symptoms and musculoskeletal health of perimenopausal women. The main questions it aims to evaluate are: 1. Can resistance training and the nutritional supplement - both independently and in combination - improve perimenopausal symptoms (e.g. cognition, mood, sleep) and musculoskeletal outcomes (e.g. strength, muscle mass)? 2. What are the acute effects of the nutritional supplement on cognitive function and mood in perimenopausal women, and is this response altered following long-term intake (12 weeks)? 3. What mechanisms may be contributing to the results? Participants will be split into four groups to allow the researchers to answer the above questions. These are: 1. The nutritional supplement + resistance training 2. The nutritional supplement only 3. The placebo supplement (A look alike capsule that contains no active ingredients) and resistance training 4. The Placebo supplement only. Participants will: * Take their allocated supplement daily and perform home-based strength exercise 3 times per week (for exercise groups), for 12 weeks. * Attend the laboratory at the beginning and end of the 12 weeks to assess cognitive function and mood following acute intake of the supplement. * Attend the laboratory every 4 weeks during the 12 week period, for assessment of cognitive function, symptom severity and muscle health. * Provide a blood sample at each visit for assessment of mechanistic pathways.

Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health

EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

The purpose of this study is to integrate Traditional Chinese Medicine (TCM) theory and therapeutic methods with modern low-level laser stimulation on corresponding acupoints, applying this combined approach to the field of weight management in menopausal women. The trial aims to investigate whether lifestyle modifications in accordance with WHO guidelines (dietary control and exercise), combined with adjunctive low-level laser acupuncture, can enhance weight reduction and improve body composition more effectively than standard lifestyle interventions alone.

Estradiol Supplementation and Rotator Cuff Repair

Rotator cuff tears in the shoulder are common causes of pain and disability, often fail to heal with surgery, and tears, worse outcomes after surgery, and failure of healing are associated with estradiol deficiency. In this study, post-menopausal women will be randomized to either estradiol patches or placebo patches after repair of the rotator cuff. The purpose of this study is to determine whether estradiol patches show promise in improving shoulder pain, strength, muscle volumes, and function when given with rotator cuff repair.

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

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.

PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition

This is a proof-of-concept phase 2 clinical trial to investigate the safety and effect of the phytoestrogenic supplement PhytoSERM on regional brain metabolism by fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in peri- and postmenopausal women. The investigators hypothesize that there will be a significant difference between the PhytoSERM group and placebo group in glucose brain metabolism.

Effects of Hemp-Derived Cannabinoids on Menopause Symptoms

The purpose of the study is to examine the impact of hemp-derived minor cannabinoids on symptoms of menopause/perimenopause.

Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions? Could these interventions reduce menopause-related inflammation, restore a healthier cardiometabolic profile, reverse epigenetic aging, and reduce bothersome menopausal symptoms? The ultimate goal of this work is to attenuate future disease and enhance women's quality of life, extend healthspan and increase productivity.

Lived Experience and Perceptions of Menopause Among Patients Participating in the Multidisciplinary Care Pathways at Paris Saint-Joseph Hospital

Menopause, often reduced to its biological aspects, is increasingly studied through medical, psychological, social, and cultural lenses. Women's experiences vary widely depending on context-country, era, and social status. Their perceptions are ambivalent: while some associate menopause with the end of fertility and burdensome physical symptoms (hot flashes, joint pain, sleep disorders, mood swings, brain fog, vaginal dryness, low libido, weight gain), others see it as a liberating phase, free from reproductive expectations. Surprisingly, 87% of women report a positive experience of menopause itself, though the transitional phase is less well-tolerated (78%). In France, where women's life expectancy is 87, they spend a third of their lives post-menopause. Yet, menopause remains a taboo subject. While 87% of women aged 50-65 experience at least one symptom beyond the cessation of menstruation, 25% suffer severe symptoms. The silence around menopause is striking: 48% of women under 50 find it difficult to discuss, 39% of pre-menopausal women feel anxious, 46% have never discussed it with their partner, and only 61% have consulted a healthcare professional. This silence stems from outdated sexist views, societal valorization of youth, lack of intergenerational dialogue, and insufficient targeted health policies, leading to isolation and invisibility. Medical support often focuses on a biomedical model, particularly Hormone Replacement Therapy (HRT), which remains controversial since the 2002 WHI study. Only 2.5% of French women over 45 currently use HRT, and 45.4% view it negatively. However, women's experiences extend far beyond hormonal concerns. To address these gaps, multidisciplinary programs-such as those at Paris Saint-Joseph Hospital and Toulouse University Hospital-offer group-based approaches, addressing physical, psychological, and relational dimensions. These programs provide a much-needed space for exchange, often absent in traditional care. Research on the benefits of collective discussion spaces (in-person or digital) in menopause care is limited, making it relevant to explore how these programs influence women's perceptions of menopause, their bodies, and their healthcare journey. While qualitative studies have examined individual experiences, few have focused on the dynamics of shared dialogue.

Effect of Laughter Yoga on Menopausal Symptoms, Sleep, and Quality of Life in Menopausal Women

This study aims to provide meaningful contributions to both academic literature and clinical nursing practice by examining laughter yoga, a non-pharmacological, evidence-based, and feasible intervention for quality of life and sleep problems commonly encountered during menopause. Menopause is a natural stage of life that can be associated with physical and psychological symptoms affecting daily life. Laughter yoga, a group-based complementary method, is based on the philosophy that "movement creates emotion" and aims to transform voluntary laughter into natural and genuine laughter over time. Laughter yoga consists of clapping and warm-up exercises, childlike games, deep breathing techniques, laughter exercises, and meditation stages. Thanks to its physiological and psychological effects, it supports individuals' overall well-being. In this study, participants will be divided into two groups: an intervention group and a control group. A pre-test will be administered to both groups to assess menopause symptoms, sleep quality, and quality of life. The intervention group will undergo eight sessions of laughter yoga, while the control group will not receive any intervention during the study period. A post-test will be administered to both groups after the intervention to evaluate its effectiveness. The results of the study are expected to contribute to determining whether laughter yoga is an effective supportive approach during menopause. It is particularly important in terms of establishing a scientific basis for the integration of complementary treatment approaches into the menopause period and ensuring that they can be integrated with nursing care.

Menopausal Impact of Opportunistic Salpingectomy for Ovarian Cancer Prevention

The goal of this clinical trial is to find out whether removing the fallopian tubes at the time of hysterectomy leads to an earlier menopause. The study includes women under 55 years of age who previously underwent hysterectomy as participants in the HOPPSA trial, where they were randomly assigned to either removal of the fallopian tubes or no removal. The main question is: • Does removing the fallopian tubes at the time of hysterectomy lead to an earlier menopause? Researchers will compare women who had their fallopian tubes removed during hysterectomy with women who had hysterectomy alone to see whether menopause occurs earlier after tube removal. Age at menopause will be estimated by measuring follicle-stimulating hormone (FSH) in small blood samples collected on a paper card. Participants will: * Collect 4-5 drops of blood using a finger prick * Place the drops on a paper card and mail it to the researchers * Complete an online questionnaire These steps will be done twice, one year apart.

Pilot Study of Individualized Treatment for Genitourinary Syndrome of Menopause in Women After Cancer Treatment

This pilot study is designed to evaluate an individualized approach to the treatment of genitourinary syndrome of menopause (GSM) in women who have undergone oncological treatment. GSM is a common condition in postmenopausal women and may include symptoms such as vaginal dryness, irritation, pain during intercourse, and urinary discomfort. These symptoms can significantly affect quality of life and sexual function, particularly in women after cancer treatment. The purpose of this study is to assess whether a personalized, non-hormonal treatment approach can effectively reduce GSM symptoms and improve overall quality of life and sexual function in this patient population. Participants will be assigned to an intervention group or a control group and will be followed prospectively over time. The study will include women in menopause who have completed oncological treatment and experience symptoms of GSM. Clinical assessments, patient-reported outcomes, and quality-of-life questionnaires will be used to evaluate treatment effectiveness and safety. The results of this pilot study may help inform future clinical practice and support the development of individualized, non-hormonal treatment strategies for women with GSM after cancer treatment.

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.

The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxiety in Menopausal Women

The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxiety in Menopausal Women

Effect of a Mindfulness-Based Stress Reduction Program on Hot Flashes and Sleep Quality in Menopausal Women: A Randomized Controlled Trial

Menopause is a natural transition characterized by vasomotor symptoms such as hot flashes and sleep disturbances, which can significantly impair quality of life. Non-pharmacological interventions are increasingly recommended for women who cannot or prefer not to use hormone therapy. Mindfulness-Based Stress Reduction (MBSR) is a structured behavioral intervention that has shown beneficial effects on stress-related symptoms and sleep quality; however, evidence regarding its effects on menopausal symptoms remains limited. This randomized controlled trial aims to evaluate the effectiveness of an 8-week MBSR program on hot flash frequency and severity and sleep quality in menopausal women. A total of 90 menopausal women will be randomly assigned to either an intervention group receiving the MBSR program or a control group receiving no intervention. Participants in the intervention group will attend weekly sessions and engage in mindfulness practices, including breathing awareness, body scan, and stress management techniques. Primary outcomes include changes in hot flash frequency and severity and sleep quality, assessed using validated self-report measures. The findings of this study are expected to contribute to evidence-based, non-pharmacological management strategies for menopausal symptoms.

Facial Yoga in Menopausal Women

Purpose: The purpose of this study is to evaluate the effects of a structured facial yoga-based behavioral intervention on perceived stress, cognitive control, cognitive flexibility, and salivary cortisol levels in women during the menopausal period. The study aims to determine whether a non-pharmacological and non-invasive behavioral intervention can support psychological and cognitive functioning and reduce biological stress responses in menopausal women. Design: This study is designed as a randomized, controlled, pretest-posttest experimental trial with a post-intervention follow-up assessment. Eligible participants will be randomly assigned to either an intervention group or a control (usual care) group. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up to evaluate both the immediate and sustained effects of the intervention. Method: A total of 100 menopausal women aged 45-65 years will be recruited from a menopause outpatient clinic and randomly allocated to either the intervention group or the control group. The intervention group will participate in a 12-week online facial yoga program consisting of two 60-minute sessions per week. In this study, facial yoga refers to a non-pharmacological and non-invasive behavioral intervention focusing on facial myofascial relaxation, breathing regulation, and body awareness for stress regulation and cognitive functioning. The program will include facial myofascial relaxation techniques, basic yoga postures suitable for all physical levels, and structured breathing exercises. All sessions will be conducted online in a group format, and no audio or video recordings will be taken. The control group will continue to receive routine outpatient care during the study period and will be offered the facial yoga program after the completion of follow-up assessments, upon request. Data will be collected at three time points: at baseline prior to the intervention, immediately after completion of the 12-week intervention, and at 8 weeks following the intervention as a follow-up assessment. Perceived stress, cognitive control, and cognitive flexibility will be assessed using validated self-report questionnaires. Salivary cortisol samples will be collected under standardized morning conditions at each assessment point to evaluate biological stress response. Hypotheses: H1: Menopausal women participating in the facial yoga intervention will demonstrate a significant reduction in perceived stress levels compared to the control group at post-intervention and follow-up assessments. H2: Menopausal women participating in the facial yoga intervention will demonstrate a significant reduction in salivary cortisol levels compared to the control group at post-intervention and follow-up assessments. H3: Menopausal women participating in the facial yoga intervention will demonstrate a significant improvement in cognitive control and cognitive flexibility compared to the control group at post-intervention and follow-up assessments.

Impact of New Hormone Replacement Therapy After Menopause on Heart Health in Women

This prospective registry study investigates the impact of new hormone replacement therapy (HRT) delivery methods, such as creams, gels, and sprays, on cardiovascular risk in postmenopausal women. Menopause-related estrogen deficiency leads to metabolic and vascular changes that increase atherosclerosis and cardiovascular events. This study hypothesizes that new HRT forms may reduce cardiovascular risk in high-risk women."

Effect of a Pender Model-Based Mobile App on Symptom Severity, Quality of Life, and Sleep in Menopausal Women With Urinary Incontinence

Objective: This randomized controlled trial aims to examine the effects of education and counseling delivered through a mobile application based on the Pender Health Promotion Model on symptom severity, quality of life, and sleep quality in menopausal women with urinary incontinence. Methods: The study was conducted at Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, targeting women who presented to the urology outpatient clinic and met the inclusion criteria. The sample consisted of 82 participants, with 41 women in the intervention group and 41 in the control group. To account for potential dropouts during the mobile intervention, the sample size was increased by 20% above the calculated requirement. Data collection tools included the Descriptive Information Form, Incontinence Quality of Life Questionnaire (I-QOL), Incontinence Severity Index (ISI), International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), and Pittsburgh Sleep Quality Index (PSQI). The intervention group received an 8-week mobile application-based education program developed in line with the Pender Health Promotion Model. Additionally, participants in the intervention group were contacted twice weekly by phone for counseling and support. The control group received no educational intervention but was assessed with pre-test and post-test measurements. Results: Data were analyzed using descriptive statistics, independent and paired sample t-tests, one-way and repeated measures ANOVA, Pearson correlation analysis, and chi-square tests for group homogeneity. The study aims to determine whether the mobile application-based intervention significantly improves urinary incontinence symptoms, quality of life, and sleep quality compared to the control group. Conclusion: This study may provide evidence supporting the use of mobile health interventions based on health promotion models like Pender's to enhance the management and overall well-being of menopausal women with urinary incontinence.