View clinical trials related to Menopause.
Filter by:Genitourinary Syndrome fo Menopause (GSM) is made up of a set of changes in the region of the vulva, vagina and lower urinary tract associated with a decrease in estrogen levels in the urogenital tissue, which leads to a reduction in blood supply, disorders in collagen metabolism and skin elasticity. The standard treatment for urinary incontinence during menopause is pelvic floor muscle training, associated or not with local hormone replacement therapy. Although low cost and easy to access, it is associated with low patient's adherence. Physical methods such as laser and radiofrequency in non-ablative, ablative and microablative forms are technologies that have recently been used in the vaginal mucosa to promote neoelastogenesis and neocollagenesis. It is hypothesized that menopausal women, who present symptoms of GSM, may benefit from this new, minimally invasive resource (microablative radiofrequency). This is a randomized clinical trial in which women aged between 40 and 65 years old will be included with clinical complaints of urinary symptoms associated with GSM. A basic anamnestic questionnaire will be used as the study instrument to collect sociodemographic, clinical data and symptoms, following the routine and standard of the service. To evaluate the treatment, the following will be used: voiding diary, pad test, vaginal cytology, histopathology, Female Sexual Function Index (FSFI), Short-Form Health Survey - SF-36 Questionnaire, King's Health Questionnaire, evolution of symptoms (dryness, pain during sexual activity, vaginal laxity, itching, burning sensation and pain in the vaginal introitus) and level of patient's satisfaction. Patients will be randomized into: group 1 or control group, which will perform pelvic floor muscle training, PFMT, with supervision (three times) and at home twice a day, and group 2 or test group, which will perform the same PFMT protocol associated with vaginal microablative radiofrequency. 10% lidocaine spray will be applied three minutes before the procedure and three applications will be made to the vagina/vaginal introitus, with an interval of 30 to 40 days. The purpose of this study is to test the efficacy and duration of effect of microablative radiofrequency in the treatment of urinary symptoms associated with GSM.
Menopause is one of the most significant lifecourse challenges for women. The decline in female sex hormones, in particular estrogen, during menopause leads to an increased risk in cardiometabolic diseases, and a decrease in quality of life due to symptoms such as low mood, anxiety, hot flushes and difficulty sleeping. As life expectancy continues to increase, on average, women will spend one third of their life in the postmenopausal period. Increasing evidence suggests that the gut microbiota plays a key role in menopause-related symptoms and conditions, being one of the main regulators of circulating sex hormones. Menopause has been linked to gut dysbiosis and lower gut microbial diversity, therefore nutritional strategies targeting the gut microbiome may be an effective approach to improve women's health during menopause. Both (poly)phenols and probiotics are promising candidates for the prevention and treatment of menopausal symptoms via different mechanisms, including the modulation of the gut-brain axis, while emerging evidence indicates that using both together may be a better approach than traditional carbohydrate-based synbiotics. To our knowledge, the efficacy of a (poly)phenol based synbiotic targeting the gut microbiome for improvement of menopausal symptoms has not been investigated so far.
Rotator cuff tears in the shoulder are common, often cause pain and disability, often fail to heal with surgery, and both tears and failure of healing are associated with estradiol deficiency. In this study, women who have gone through menopause 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, and function when given with rotator cuff repair.
The perimenopause is known as a vulnerable period for some women, with noticeable somatic and psychological issues. Aside from climacteric symptoms, insomnia and depression are common. About half of women during the peri-menopausal period experience sleep problems like problems falling asleep, awakening during the night and being unable to return to sleep. This is often attributed to vasomotor symptoms, but this is not the only reason of poor sleep (Joffe et al., 2010). Also, the peri-menopausal period is a critical time for the occurrence of new onset and recurrent depressions (Cohen et al., 2006). It has been suggested that fluctuations in estradiol may increase the risk for depression by altering neuronal functions in the brain. But there are also indications that the risk for depression increases by indirect effects, such as the increase in insomnia. Poor sleep has increasingly been recognized as the key modifiable factor affecting mental issues like depression (Van Someren, 2021). While antidepressants and psychotherapies continue to be the treatments of choice for depression, and Cognitive Behavioral Therapy for sleep (CBTi) for insomnia, preclinical and clinical data support the benefits of estrogen-based therapies to improve mood, sleep and other menopause-related symptoms (Gordon et al. 2018). Transdermal estradiol patches, which provide a stable release of estradiol and lead to more stable blood levels, have been suggested to have a positive effect on sleep (Joffe et al., 2020) and depressive symptoms (Gordon et al., 2018) in randomized controlled trials. However, it is currently unclear if the relation between improvement in mood and estradiol patches is mediated by improvement in sleep problems, and if the effect of estradiol patches on sleep problems is more effective during peri-menopause than the current evidence-based sleep interventions of CBTi, preferably in combination with Circadian Rhythm Support (CRS). The aim of the study is to pinpoint the determinants of complaints about sleep and mood and how they respond to Menopausal Hormone Treatment (MHT) with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS. Measurements will be conducted at baseline (T0), 2 months (T1) and 4 months (T3), with questionnaires, sleep measurements (EEG sleepband and actigraph) and skin conductance (to measure hot flushes). Participants will be recruited via www.slaapregister.nl and via OLVG outpatient clinic population of peri-menopausal women seeking help for climacteric complaints (like hot flushes, feeling bloated, increase in weight), including sleep problems. The participants are adults between 40-55 years old, with an Insomnia Severity Index score ≥10 and Climacteric Green Scale score ≥ 13.They have the self-considered capability to complete online questionnaires and diaries in Dutch. The intervention will be MHT (estradiol transdermal patches 50 mcg (Systen), in combination with 200 mg progesterone (Utrogestan tablets for 2 weeks, adjusted to the menstrual cycle to prevent endometrium carcinoma according to the international MHT guidelines), with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS.
The purpose of this research study is to evaluate the effectiveness of the study product on vasomotor symptoms (VMS) and overall menopause symptoms in healthy women, who are perimenopausal or postmenopausal, and aged 40 - 65.
This study aimed to determine the effects of Kegel exercise and Ba Duan Jin applications applied to premenopausal women with urinary incontinence on quality of life and psychological well-being. Study Group of the Research: Premenopausal women between the ages of 45-55 who come to the family health center with any complaint and have urinary incontinence. The research will be conducted as a randomized pre-test, post-test and control group intervention study design. The research will be conducted with women aged 45-55 with urinary incontinence who came for examination for any reason to a Family Health Center in Sinop between March 2024 and July 2024. According to the power analysis, the number of participants was calculated to be at least 54 when the type 1 error was taken as 0.05, the power was 0.95 and the effect size was medium (0.25) for the two-group design with two repeated measurements. To prevent possible data loss, the sample size was increased by 10% and the total number of participants was determined as 60. A total of 60 women, 30 experimental and 30 control, coming to the Family Health Center will be randomly included in the study. No information, Kegel exercise program and Ba Duan Jin applications will be given to the women in the experimental group, and no intervention will be given to the control group during the research process. Participants will be assigned to 2 groups: experimental and control. Those who come to FHC on odd days of the month will be included in the experimental group, and those who come on even days of the month will be included in the control group. Each group will be determined as 30 people. After the research is completed, the interventions applied to the experimental group will be applied to the women in the control group. Personal Information Form, Psychological Well-Being Scale and Incontinence Quality of Life Scale will be applied to women in the experimental and control groups as pre-test measurements. As a final test, the same measurements will be made to both the control group and the experimental group 16 weeks after the first measurement.
The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen.
In Greece, people of different age groups, including young children to older adults, are involved in traditional dance. To date, the well-know benefits of dancing include entertainment, socialization and increased physical activity. However, the acute effects of Greek traditional dancing on health, physical performance and muscle damage indices remain largely unknown. Therefore, the aim of this project is to evaluate the acute effect of Greek traditional dancing on health-, physical performance-, and muscle damage-related parameters by considering the impact of dancing tempo (slow vs moderate vs fast). In a crossover repeated measures design 10 pre- and 10 post-menopausal women will participate in the three dancing sessions of different tempo in a random order.
The aim of this research is to 1) test how the skin blood vessels and sweat glands function in women who experience hot flushes by using skin microdialysis to deliver small amounts of substances to the skin that cause increased skin blood flow and sweating, and 2) examine the structure of the skin blood vessels and sweat glands in the skin of women who experience hot flushes by taking a very small skin biopsy. Any changes in the function or structure of the skin blood vessels or sweat glands in women with hot flushes would increase our understanding of what causes hot flushes and help to design effective treatments.
The goal of this clinical trial is to investigate the effects of red clover isoflavones on menopausal symptoms and lipid profile in menopausal females.This prospective randomized, double-blind, placebo-controlled study included postmenopausal women with dyslipidemia. The red clover group received 40 mg isoflavone red clover capsule twice daily for 6 months, while placebo was 40 mg starch capsules, twice daily. Data were collected at baseline, 3 months and 6 months. The study was completed with 75 subjects [red clover (n = 39), placebo (n = 36)]. Menopause Rating Scale (MRS) was applied to calculate subdimension and total scores. Blood lipid profile, including total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride levels were measured.