Clinical Research Directory

A Study to Assess the Bioavailability and Adhesion of Estradiol/Levonorgestrel TDS in Healthy Post-Menopausal Female Participants

The purpose of this study is to compare the bioequivalence and adhesion performance of a test estradiol/levonorgestrel transdermal delivery system (TDS) with the reference product, Climara Pro® (estradiol/levonorgestrel transdermal system), following a single 7-day application in healthy postmenopausal female participants. The study will also evaluate the safety and tolerability of the test and reference patches.

Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)

HOPES (Hops On Psychological and Estrogenic Symptoms in Menopause) is a randomized, double-blind, active-controlled nutritional intervention study in 120 peri- and postmenopausal women aged 45 to 60 years with moderate to severe menopausal symptoms. For 12 weeks, participants take one capsule per day of either a full spectrum hop (Humulus lupulus L.) extract or a soy isoflavone extract. Both products are marketed dietary supplements, and there is no placebo arm. The main question is whether the hop extract, which combines prenylated flavonoids with bitter acids, improves the psychological symptoms of menopause (depressive mood, irritability, anxiety, and physical and mental exhaustion) more than the soy extract. The main outcome is the change in the psychological subscale of the Menopause Rating Scale (MRS) from baseline to week 12. Secondary outcomes include the other MRS domains, anxiety, depressive symptoms, menopause-related quality of life, body composition, and safety.

Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Peri- and Postmenopausal Women

Menopause is a biological process characterized by the permanent cessation of menstruation, often accompanied by vasomotor symptoms, sleep disturbances, anxiety, and impaired quality of life. In primary healthcare settings, structured lifestyle interventions offer low-cost, safe, and sustainable non-pharmacological management strategies. The objective of this prospective, randomized controlled trial is to evaluate whether a structured lifestyle educational intervention leads to significant improvements in menopausal symptom severity, sleep quality, and anxiety levels compared with a control group receiving routine clinical care among perimenopausal and postmenopausal women aged 40 to 55 years. Primary and secondary outcomes are evaluated using the Menopause Rating Scale (MRS), Pittsburgh Sleep Quality Index (PSQI), and Generalized Anxiety Disorder-7 (GAD-7) at baseline and at 24 weeks.

Effects of a Dietary Supplement in Women With Late Perimenopause or Early Postmenopause

This study will evaluate the effects of a plant extract-based dietary supplement on menopausal symptoms and health indicators in women with late perimenopause or early postmenopause. Approximately 120 women aged 42 to 60 years will be randomly assigned to receive either the dietary supplement or a placebo daily for 12 weeks. Neither the participants nor the research team will know the assigned treatment during the study. Assessments will include the frequency and severity of hot flashes and night sweats, menopausal symptoms, quality of life, sleep quality, emotional well-being, body composition, and selected laboratory parameters.

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.

On the Effect of a Hybrid Health Literacy Intervention on Sexual Function and Digital Health Literacy in Menopausal Women

This randomized controlled study will evaluate whether a hybrid health literacy education program improves sexual function and digital health literacy in postmenopausal women. Hybrid education combines in-person and online sessions. The study will include 128 women aged 45-60 years who have not had a menstrual period for at least 12 months. Participants will be recruited from the gynecology and obstetrics outpatient clinic at Kahramanmaraş Sütçü İmam University Hospital in Türkiye and randomly assigned to an education group or a usual-care group, with 64 women in each group. The education group will receive a midwife-led program consisting of one in-person session and two online sessions over three weeks. The sessions will cover sexual health during menopause, finding and evaluating reliable online health information, and using this information in daily life. Women in the usual-care group will continue to receive routine health services without additional study education. Participants in both groups will complete questionnaires assessing sexual function and digital health literacy before and after the intervention period. Researchers will compare changes between the groups to assess the effects of the education program.

Exercise and Prolonged Fasting to Improve Brown Adipose Tissue Function in Postmenopausal Women

Type of Study: Clinical Trial Goal: The goal of this clinical trial is to investigate mitochondrial function in interscapular brown adipose tissue (iBAT) in postmenopausal women and determine whether aerobic exercise, prolonged fasting, or their combination can improve iBAT mitochondrial function and whole-body metabolic flexibility. Participant Population/Health Conditions: The study will involve 60 postmenopausal women aged 45-65 years living with overweight or obesity. Main Questions: The main questions this study aims to answer are: * What are the mitochondrial function and cellular characteristics of iBAT in postmenopausal women? * Can aerobic exercise or five-day prolonged fasting improve mitochondrial function in iBAT and whole-body metabolic flexibility? * Does combining aerobic exercise with prolonged fasting produce greater metabolic adaptations than either intervention alone? * Are improvements in metabolic flexibility maintained four weeks after the intervention? Participants Will: Be randomized into one of four groups: control, aerobic exercise, prolonged fasting, or combined aerobic exercise plus prolonged fasting. Follow their assigned intervention for five consecutive days. Undergo metabolic and physiological assessments before and after the intervention and again four weeks later. Provide dorsocervical adipose tissue biopsies and biological samples to investigate mitochondrial function, adipocyte characteristics, and metabolic adaptations. Comparison Group: Researchers will compare the effects of aerobic exercise, prolonged fasting, and their combination with a control condition to determine their effects on iBAT mitochondrial function and whole-body metabolic flexibility.

The Effect of Structured Health Information-Seeking Training on Cyberchondria and E-Health Literacy in Menopausal Women: A Randomized Controlled Trial

This randomized controlled study will examine whether two different forms of structured health information-seeking education can help women in perimenopause or postmenopause use online health information more effectively. It will assess whether video-based education and Pecha Kucha-based education reduce cyberchondria, which refers to repeated online health searches that may increase health-related worry, and improve e-health literacy and knowledge about menopause. The study will include 60 women aged 40 to 65 years. Participants will be randomly assigned in a 1:1:1 ratio to a video-based education group, a Pecha Kucha-based education group, or a control group, with 20 participants in each group. The education will cover how to identify reliable online health sources, evaluate health information, recognize misleading content, use effective search methods, and avoid online searching behaviors that may increase anxiety. The control group will not receive structured education during the study period. Outcomes will be assessed before the intervention, immediately after the intervention, and one month later. The findings will help determine which educational method is more effective in supporting safe and informed online health information-seeking among women during the menopausal transition.

To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets .

A Drug-Drug Interaction Study to Evaluate the Effect of Smoking (CYP1A2 Inducer) on the Pharmacokinetics Following a Single Oral Dose of GS1-144 Tablets in Chinese Healthy Postmenopausal Female Trial Participants

Spirulina Supplementation in Postmenopausal Women

The purpose of this study is to investigate the effects of spirulina supplementation on weight gain associated with menopause, changes in metabolic parameters, sleep quality, and markers of depression in mildly overweight postmenopausal women, and to evaluate the changes that occur in these parameters.

Nurses' Health Study (Cardiovascular Component)

To determine the relationships of hormonal, reproductive, dietary, and lifestyle factors, as well as biochemical and genetic factors, with the subsequent risk of coronary heart disease and other cardiovascular events in a cohort of female registered nurses. The current funding cycle involves comprehensive metabolomic profiling of coronary heart disease cases and controls and development of metabolomic risk scores for coronary heart disease.

Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy

Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide, with the highest incidence of any cancer type. The choice of therapeutic interventions hinges upon factors like cancer stage, cell subtype, and tumor size. Consequently, individuals with more aggressive tumors, such as HER+2 and Triple Negative, or larger tumors often undergo neoadjuvant chemotherapy before breast surgery. However, these anticancer treatments come with side effects like cancer-related fatigue, reduced functional capacity, and changes in body composition, notably skeletal muscle atrophy. Skeletal muscle loss correlates with heightened mortality rates, cardiotoxicity, and diminished quality of life, underscoring the need for early therapeutic interventions. One such promising strategy is prehabilitation, which involves resistance-exercise training aimed at bolstering skeletal muscle mass from the outset of the disease, even preceding breast surgery. Resistance-exercise training has shown favorable effects on women undergoing adjuvant therapy or survivors of breast cancer, however, its molecular and clinical effects in women with breast cancer undergoing neoadjuvant therapy are unknown.

The Effect of EX-PLISSIT Model-Based Sexual Counseling in Postmenopausal Women

The study will be conducted in two groups as counseling and control. Participants will be approached at the Public Education Center. After postmenopausal women are evaluated according to eligibility criteria, those who are eligible will be informed about the research and written informed consent will be obtained from those who agree. Random assignment of women to the study groups will be carried out using randomization. This study aimed to determine the effects of sexual counseling based on the EX-PLISSIT model on sexual quality of life, sexual satisfaction, and perceptions of sexuality in postmenopausal women.

Oral Antioxidant Therapy Targeted to the Mitochondria for Improving Brain Artery Health in Postmenopausal Women

The goal of this clinical trial is to learn if 3 months of taking the dietary supplement MitoQ \[a mitochondria-targeted antioxidant that targets to reduce mitochondrial reactive oxygen species (mitoROS)\] works to treat age- and menopause-related reductions in brain artery (cerebrovascular) function in postmenopausal women 60 years of age or older free of clinical disease. The main questions it aims to answer are: Does MitoQ improve cerebrovascular function in postmenopausal women? If so, does MitoQ improve cerebrovascular function by lowering mitoROS in these arteries? Researchers will compare MitoQ to a placebo (a look-alike substance that contains no drug) to see if MitoQ can improve cerebrovascular function by lowering mitoROS in arteries involved in brain health and function. Participants will: Take MitoQ (20 mg/day) or a placebo every day for 3 months Visit the research laboratory at baseline and then after 3 months for cerebrovascular testing; there is also a check-in visit at 6 weeks, which is the halfway point Keep track of symptoms and events during their treatment period to report to the study team

The Influence of Hormone Replacement Therapy and Supervised Exercise Training on Body Composition, Cardiovascular Risk and Insulin Sensitivity in Postmenopausal Women

This trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk, risk for dementia, osteoporosis and insulin sensitivity in postmenopausal women.

GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women

The aim of this study is to assess the effectiveness of GLYLO, a dietary supplement, in postmenopausal women aged 45 to 65 who are overweight or obese and have elevated HbA1c levels. Specifically, the study seeks to evaluate whether GLYLO can reduce advanced glycation end products (AGEs) levels, which are harmful compounds formed when sugar attaches to proteins or fats in the body and can contribute to aging and disease. The primary outcome of the study is to determine if GLYLO reduces AGEs, enhances metabolic and hormonal health, and mitigates age-related functional decline. This study includes one screening visit and three testing visits over a 6-month period. After eligibility is confirmed, participants will be randomly assigned to one of two groups to take either GLYLO (two capsules daily) or a placebo at home for 24 weeks. Participants will provide blood samples at every visit. During the three testing visits, they will complete physical performance and cognitive function tests, provide both blood and urine samples, and fill out quality of life and 24-hour dietary intake questionnaires. The dietary intake questionnaires will be completed only twice i.e. at the baseline visit and again at the final 6-month visit.

The Effect of Sujok Therapy on Urinary Incontinence and Quality of Life in Postmenopausal Women

This study aims to investigate the effect of Su Jok therapy, a complementary medicine practice, on urinary incontinence and quality of life among postmenopausal women. A total of 120 participants will be included in the study, with 60 in the intervention group and 60 in the control group. Participants in the intervention group will receive Su Jok seed therapy applied to the hand reflex points corresponding to the bladder. The therapy will be administered by the researcher and then taught to the participants, who will continue the application for 15 days. Assessments will be conducted at baseline, day 15, and day 30 using validated questionnaires.

Resting Energy Expenditure in Postmenopausal Women

Obesity and its associated comorbidities are rising at an alarming rate, particularly among postmenopausal women. Menopause, characterized by a decline in estradiol and progesterone levels, is often accompanied by weight gain. Fear of this weight gain is a major reason why many women hesitate to initiate or continue menopausal hormone therapy (MHT), with discontinuation often occurring within the first few months. However, scientific evidence on whether MHT influences weight gain remains inconclusive. A Cochrane Review found no significant effect of estrogen or combined estrogen-progestogen therapy on menopause-related weight gain, suggesting that aging and lifestyle changes play a more prominent role. While the effects of estrogen on energy intake have been well-documented, data on its impact on energy expenditure-particularly resting energy expenditure (REE), the largest component of total energy expenditure-are scarce. Several studies suggest that sex hormones may influence REE, as observed in premenopausal women, where REE increases during the luteal phase when estradiol and progesterone levels are high. However, findings on this topic remain inconsistent, and it is unclear whether estrogen or progesterone plays the primary role. Research on the effects of exogenous hormone administration, such as MHT, on REE is extremely limited, with existing studies producing mixed results. Additionally, the potential influence of progestogens on REE has been largely overlooked. Given that a low REE is a strong predictor of weight gain and obesity, understanding the effects of MHT on REE is crucial. This observational clinical trial aims to investigate the precise effect of MHT (estradiol + progesterone) on REE in postmenopausal women with an indication for MHT. Secondary objectives include examining MHT's impact on energy intake, physical activity energy expenditure, performance capacity, body composition, core body temperature, serum hormone profiles (luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone), glucose metabolism, fasting blood lipid levels, and miRNA expression (miR-370 and miR-29b, which are involved in lipid and glucose metabolism). Additionally, the study will assess various aspects of subjective well-being and quality of life. By addressing the current gaps in scientific knowledge, this study seeks to provide robust evidence on the role of MHT in energy metabolism, potentially reshaping perspectives on its risks and benefits in postmenopausal women.