Clinical Research Directory

Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women

This clinical study aims to compare the effects of time-restricted eating and a personalized energy-restricted diet on anthropometric measurements, body composition, biochemical parameters, blood pressure, handgrip strength, menopausal symptoms, and sleep quality in obese postmenopausal women. The study is a 12-week, open-label, controlled, parallel-group clinical trial with a quasi-randomized allocation design. The coordinating center is the Department of Internal Medicine, Faculty of Medicine, Gazi University, and the study will be conducted at the Internal Medicine Outpatient Clinic of Cihanbeyli State Hospital in Konya, Türkiye. A total of 40 postmenopausal women are planned to participate, with 20 participants in each group. Participants will undergo an initial medical examination and baseline assessments, including demographic and health information, dietary habits, menopausal symptoms, sleep quality, physical activity, and dietary intake. Anthropometric measurements, body composition, handgrip strength, blood pressure, and biochemical parameters will also be assessed. Participants in the intervention group will follow a time-restricted eating schedule in which they will consume food within an 8-hour daily eating window and fast for 16 hours. The eating window will begin between 8:00 AM and 12:00 PM and will be determined by the participant. During the fasting period, water, unsweetened tea, plain coffee, and plain mineral water will be permitted. Participants in the control group will follow a personalized energy-restricted diet providing approximately 25% less energy than their estimated energy requirements. The diet will be planned according to menopausal nutrition recommendations and individual preferences. Dietary intake will be monitored every 2 weeks. Anthropometric measurements, blood pressure, and handgrip strength will be assessed every 4 weeks. All baseline assessments will be repeated after the 12-week intervention period. The study hypothesis is that time-restricted eating will result in greater improvements than the personalized energy-restricted diet in anthropometric measurements and body composition, biochemical parameters, blood pressure, handgrip strength, menopausal symptoms, and sleep quality in obese postmenopausal women.

Self-Management Box on Hot Flash in Postmenopausal Women

Aim of the study This study aims to evaluate the effect of a nurse-led menopause self-management box on hot flash frequency and menopause-specific quality of life among postmenopausal women. Research hypotheses * Postmenopausal women who receive the nurse-led menopause self-management box will demonstrate significantly lower mean daily hot flash frequency immediately after the four-week intervention and at the three-month follow-up compared with baseline. * Postmenopausal women who receive the intervention will demonstrate significantly lower hot flash severity immediately after the four-week intervention and at the three-month follow-up compared with baseline. * Postmenopausal women who receive the intervention will demonstrate significantly lower MENQOL scores, indicating improved menopause-specific quality of life, immediately after the four-week intervention and at the three-month follow-up compared with baseline.

Examination of the Effects of Pelvic Floor Exercises on Vaginal and Sexual Health in Postmenopausal Women.

The purpose of this study; To investigate the effects of pelvic floor muscle exercises on vaginal and sexual health in postmenopausal women. Vaginal symptoms such as vaginal dryness, burning and dyspareunia occur in the postmenopausal period. Vaginal symptoms affect sexual function, leading to a decrease in quality of life. In our study, we plan to evaluate vaginal dryness, one of the vaginal symptoms, using Schirmer's Test. Also in our study; Severities of vaginal dryness, burning and dyspareunia will be evaluated with the visual analog scale (VAS), sexual function will be evaluated with the Post-Menopausal Sexuality Questionnaire and Female Sexual Function Scale, vaginal aging will be evaluated with the Daily Effect of Vaginal Aging Scale, and the presence/severity of pelvic floor symptoms will be evaluated with the Pelvic Floor Distress Inventory-20. The cases will be randomized into two groups and pelvic floor exercises will be given to one group. After the exercises are given, vaginal pH and moistness will be evaluated for acute effect. In the other group, vaginal PH and moisture will be measured after 5 minutes. The cases will be followed without any intervention to the control group. After 12 weeks, the same evaluations will be made to both groups and the results will be compared. The data will be compared using appropriate statistical methods (statistical significance value will be taken as p\<0.05) and discussed with the literature.

Telerehabilitation Versus Supervised Pelvic Floor Muscle Training in Urinary Incontinence

Urinary Incontinence (UI) is a prevalent condition impacting women across all age groups, varing in both severity and type. Urinary Incontinence affects 25%-45% of women worldwide. A systematic review explains that menopause-driven estrogen decline leads to atrophy of pelvic floor muscles (PFM). The goal of this randomized controlled trial is to compare the effects of telerehabilitation-based pelvic floor muscle training with a supervised face-to-face pelvic floor muscle training program in improving urinary incontinence symptoms, pelvic floor muscle funtion and quality of life (QoL) in postmenopausal women. Participnts will be randomly assigned to one of the two groups, and both will receive an identical standardized pelvic floor muscle training protocol. The results of this clinical trial will help evaluate how telerehabilitation can provide support for postmenopausal women with urinary incontinence and improve health outcomes.

Circadian Rhythms in Postmenopausal Women

This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.

Relaxation Training Via Tele-Rehabilitation in Postmenopausal Women

Menopause is associated with various physiological and psychological changes that may adversely affect women's quality of life. Menopausal symptoms, sleep disturbances, and fatigue are among the most common complaints during the postmenopausal period. Non-pharmacological interventions, such as relaxation training, have been suggested as effective approaches for managing these symptoms. This randomized controlled trial aims to investigate the effectiveness of a physiotherapist-supervised relaxation training program delivered synchronously via tele-rehabilitation on menopausal symptoms, sleep quality, and fatigue in postmenopausal women. Thirty women in the early postmenopausal period will be randomly assigned to either an intervention group receiving a 6-week tele-rehabilitation-based relaxation training program (twice weekly) or a control group receiving no structured intervention. Outcomes, including menopausal symptoms, sleep quality, objectively monitored sleep parameters, and fatigue, will be assessed before and after the intervention using validated outcome measures. The findings of this study are expected to provide evidence regarding the feasibility and effectiveness of tele-rehabilitation-based relaxation training as a non-pharmacological approach for managing postmenopausal symptoms.

Cholinergic Health After Menopause (CHAMP)

Women are at increased risk for Alzheimer's disease (AD). Notably at menopause, some women experience a change in cognition. However, not all women experience negative effects of menopause on cognition. The cognitive changes that occur at menopause have not yet been connected to late life risk for pathological aging including AD. Thus, understanding the neurobiological factors related to individual differences in cognition at menopause is critical for understanding normal cognitive aging and for determining risk for pathological aging. The challenge in understanding the role of estrogen loss on the risk for AD is the long lag time between the hormonal changes at menopause and the clinical manifestations of AD. Thus, identifying how the hormone changes after menopause are related to AD risk will alter the risk calculus for postmenopausal women in the future. The novel study proposed here will examine an established AD-related neurotransmitter-based mechanism that may also underlie cognitive changes after menopause. The investigators propose that the change in the hormonal milieu at menopause interacts with the cholinergic system and other brain pathologies to influence a woman's risk for cognitive decline. Preclinical studies have shown that estrogen is necessary for normal cholinergic functioning and its withdrawal leads to cholinergic dysfunction and cognitive impairment. It is important to determine whether menopause-related cognitive changes correlate with both cholinergic functional integrity and established AD biomarkers that portend increased risk for late-life cognitive impairment or dementia. This study will examine brain functioning following cholinergic blockade to separate individuals into those who are able to compensate for the hormone change after menopause and those who are not. The investigators hypothesize women with poor compensation have increased sensitivity to cholinergic blockade by showing poor performance on a cognitive task, altered brain activation, and decreased basal forebrain cholinergic system (BFCS) volume. These cholinergic markers will be related to menopausal factors associated with poor cognition and biomarkers of AD. Specific Aim 1 is to examine cholinergic functional "integrity" by measuring working memory performance, functional brain activation, and BFCS structure in postmenopausal women. Specific Aim 2 will examine whether individual differences in menopause-relevant symptoms and known AD biomarkers are related to cognition and brain activation after anticholinergic challenge. The public health significance of this study is that it will identify individual difference factors that are associated with cognitive performance changes after menopause and their relationship to structural, functional, and biomarker evidence of risk for later life cognitive dysfunction. Knowledge of these factors will serve to advance personalized future risk-mitigation strategies for women including hormonal, medication, cognitive remediation, etc. that will be the subject of further research.

Multimodal Program for Climacteric Women

Your study seems to aim at emphasizing the significance of non-pharmacological and non-hormonal approaches in managing menopausal symptoms, particularly focusing on muscle training and education. This holistic approach acknowledges the importance of physical well-being, psychological support, and education to enhance women's quality of life during the menopausal transition.

Exercise Training and Fat Metabolism in Postmenopausal Women

Adipose tissue turnover plays a critical role in body weight maintenance, and obesity is underscored by the dysregulated balance between fat breakdown and synthesis. Although there are clear health-related benefits of physical activity, little is known about how resistance exercise, as opposed to endurance exercise, can reduce the risk of metabolic disorders, particularly in women. The goal of the proposed study is to investigate the effectiveness of resistance training to improve basal and stimulated fat metabolism in postmenopausal women with obesity and pre-diabetes, potentially serving as a viable and practical approach to prevent the onset of type 2 diabetes.

Psychosocial Effects of Mindfulness-Based Exercise in Postmenopausal Women

Menopause is a natural biological process characterized by the permanent cessation of the menstrual cycle in women. Hormonal changes associated with menopause commonly lead to mood swings, anxiety, depression, stress, and decreased sleep quality in women. While the current literature indicates that mindfulness-based interventions offer potential benefits in alleviating psychological and physical symptoms in postmenopausal women, the limited number of studies in the literature and methodological differences suggest a need for more randomized controlled trials in this area. The aim of this study is to examine the effect of mindfulness-based exercises on psychosomatic complaints such as anxiety, depression, and sleep quality in postmenopausal women. Designed as a randomized controlled experimental study, it was planned to include at least 20 women in the early postmenopausal period residing in Istanbul and Izmir between March and June 2026. The women included in the study will be randomized into Group 1 (n=10), which will perform mindfulness-based exercises, and Group 2 (n=10), which will receive no intervention as usual. The STAI I-II Form State and Trait Anxiety Scale and Beck Anxiety Inventory will be used to assess state and anxiety level, the Beck Depression Scale for depression level, and the Pittsburgh Sleep Quality Scale for sleep quality. Continuous variables will be presented as mean ± standard deviation, and qualitative variables as number and percentage (%). If parametric test assumptions are met, the Independent Samples t-test will be used to compare independent groups, and the Paired Samples t-test will be used to compare dependent groups. If parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent groups, and the Wilcoxon test will be used to compare dependent groups. Statistical significance will be set at p≤0.05. This study is expected to contribute to the literature by providing evidence-based data on the effectiveness of mindfulness-based exercises on common psychological symptoms in the postmenopausal period.

Estrogen Deficiency on Cardiovascular Risk

To explore how estrogen deficiency impacts the blood pressure (BP) and sympathetic nerve activity (SNA), and how it impacts the production of the key pro-inflammatory mediators such as Tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It is hypothesized that estrogen deficiency increases BP, SNA and the pathway activities of the key pro-inflammatory mediators. Those effects are impacted through the downregulation of the estrogen receptor.

PRP Injections for Genitourinary Syndrome of Menopause

Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has been patented as the O-Shot and V-Shot. This is a single-blinded randomized control trial to determine if PRP injections into the anterior vaginal wall improve sexual functioning in women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal dryness/irritation.

LASER and Radiofrequency and Genitourinary Syndrome of Menopause

This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic strogen to treat symptoms of vulvovaginal atrophy of post menopause.

Hormone Replacement Trial Against ALzheimers' Disease

The influence of postmenopausal hormone treatment on dementia is not clear. Dysfunctions in the metabolism of amyloid in the disease of Alzheimer result in an elevated presence of degradation products in cerebrospinal fluid. The degradation products in blood will be analysed during the trial, to get better insight in menopause and the start of hormonal therapy. Postmenopausal women with and without history of breast cancer will be recruited for the trial.

Sexual Effects of Transdermal or Vaginal Testosterone

The aim of the study is to elucidate the role of testosterone treatment in postmenopausal women's sexual function and their therapeutic safety.

Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women

The goal of this randomised controlled trial is to investigate the effects of and compare two modes of physical exercise (strength training and high-intensity aerobic exercise) to unchanged physical activity on vasomotor symptoms (hot flushes) in postmenopausal women. The main question it aims to answer is the effect of 15 weeks of strength training vs high intensity aerobic training vs unchanged physical activity on frequency and severity of hot flushes. Participants will be randomised to: 1. strength training 2. high-intensity aerobic training 3. untreated control group. Researchers will compare strength training, high-intensity aerobic training and untreated control group to see if training can reduce hot flushes.

Virtual perI-/Menopause Registry of AusTrALia

13 million (50.7%) Australians are born with ovaries, 14% (\~3 million) are currently aged 40-59 yrs, \& all such who live to midlife will experience menopause, defined as \>12 months without a period. Peri-menopause (peri), typically occurs 5 yrs before menopause as hormone levels decrease. As with oestrogen, peri symptoms can affect every bodily system; e.g. depression/anxiety, diminished mental function, irregular periods, hot flushes, sleep problems, vaginal atrophy \& urinary urgency. These symptoms are linked with lower quality of life \& significantly higher work impairment; a third experiencing symptoms so severe as to impede daily life \& increase risk of suicide. Lifetime increased risks of diabetes, heart disease, osteoporosis \& dementia are also associated with menopause, yet it remains disconcertingly poorly studied. The investigators propose to create a world-first, cutting-edge, consumer-driven, Virtual peri-/menopause registry of AusTrALia (VITAL). The unique design will enable consumers to determine VITAL's questions, encourage secure revelation of private data e.g. vaginal \& mental health symptoms, \& to direct priorities for research, education, \& health service improvements. VITAL will thus deliver optimal assessments of incidence, prevalence \& impact. The participating consumers, researchers, clinical specialists, policy makers, \& modern virtual data infrastructure enable this unique \& innovative registry design, future translation to improved community health, \& promote awareness \& collaborative synergies. Leveraging the investigators' critical range of expertise \& ongoing feedback opportunities for both participants \& stakeholder partnerships, the investigators will create a ground-breaking platform that: * empowers the consumer voice and priorities, * enables peri-/menopause research to extend beyond existing niche focuses, * evidences the true impact of peri-/menopause across the nation, * evolves healthcare services and outcomes, \& * educates community, clinicians, \& policy-makers. After Australian registry establishment, the investigators will expand VITAL to mirror it in other nations while still protecting individual's data the right way, but so all can learn \& apply the best aspects of care from across the world.

Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women

The goal of this clinical trial is to learn about the effects of phytoestrogen from Pueraria Mirifica in improvement of serum lipid parameters. The primary question it aims to answer are: • phytoestrogen from Pueraria Mirifica can reduce serum triglyceride, total cholesterol, LDL and increase HDL or not Participants will receive capsules which composed of dry weight 50 mg of Pueraria Mirifica twice a day for 2 months. Researchers will compare with diet control\&life style modification to see if there is the improvement of serum lipid parameters