Menopause

Researchers are evaluating the effects of Poly L-lactic Acid PLLA biostimulator treatment on women at various menopausal stages who have moderate-to-severe cheek wrinkles. This randomized, prospective study aims to assess changes in protein expression in the skin after treatment, using punch biopsies taken at several follow-up visits compared to baseline. The study is sponsored by Galderma R&D and involves about 40 participants across two sites. Participants will receive Sculptraae, a biostimulator device, applied to both cheeks in up to three treatments spaced four weeks apart. Initially, a punch biopsy is taken on one pre-auricular cheek side at baseline. After the first and second treatments, participants may receive a third optional treatment at week 8. At 12 weeks after the last Sculptra treatment, half of the subjects will have a second punch biopsy on the opposite cheek side, with the rest receiving this biopsy at 36 weeks post-treatment. Follow-up visits occur at 24 weeks after the final treatment. During the study, participants will be monitored through physical assessments, biopsy procedures, and self-assessment questionnaires measuring satisfaction at 12, 24, and 36 weeks after treatment. Researchers will analyze protein expression changes and track participant experiences. The study includes safety and adherence monitoring throughout the treatment and follow-up period, lasting up to 36 weeks after the last Sculptra treatment.

Researchers are evaluating the effects of different pollen extracts on menopausal symptoms in healthy women aged 45 to 65 years. The study aims to compare changes in symptom severity, measured by the Menopause Rating Scale MRS, between Graminex Water Soluble Pollen Extract WSPE, Graminex Lipid Soluble Pollen Extract LSPE, and a placebo over 36 weeks. This Phase 2, randomized, triple-blind, placebo-controlled trial assesses how these extracts impact menopausal symptoms including vasomotor, psychological, and urogenital domains. Participants are randomly assigned to receive either Graminex WSPE, a water soluble pollen extract standardized to 6% amino acids Graminex LSPE, a lipid soluble pollen extract standardized to 7% phytosterols or a placebo. The intervention lasts for 36 weeks, during which participants complete the MRS assessment tool at baseline and at several points up to Week 36 to rate their menopausal symptoms. The study uses a parallel design and quadruple masking to compare the effects of these treatments. Throughout the study, participants provide symptom ratings using the MRS at baseline, Week 6, 12, 24, and 36. Researchers monitor changes in total MRS scores as well as individual symptom domains such as sleep disturbance, mood, and physical symptoms. The trial includes regular assessments to capture symptom changes over time, with safety and adherence monitored by qualified investigators. Participation will last approximately 36 weeks from baseline to the final outcome measurement.

This research aims to evaluate if men with prostate cancer who experience hot flashes from their androgen deprivation therapy ADT will consistently wear a smartwatch to track their health data and log hot flashes. The study focuses on comparing smartwatch data with daily surveys about hot flash experiences to better understand these symptoms. The study is conducted with patients receiving ADT who report daily hot flashes and are willing to use wearable technology for monitoring. Participants will be given an EmbracePlus smartwatch and a charging device after consent and eligibility confirmation. They will be trained to use the device, including how to log hot flashes by pressing a button on the watch. The smartwatch pairs with a smartphone app to transmit biometric data and hot flash events to a cloud server for research access. Participants will wear the watch continuously for 28 days, except for charging, and receive up to four daily surveys through text message links to report their hot flash experiences. Throughout the study, participants will be monitored by the research team who will verify data collection and device use. They will receive a check-in call and complete an end-of-study survey. Researchers will measure the duration of watch wear per day, the percentage of days with self-reported hot flash events, and how well smartwatch logs match the surveys. The total participation lasts 28 days, during which biometric data and subjective hot flash reports are collected and analyzed.

This research aims to understand how menopause affects the risk of cardiovascular diseases such as atherosclerosis, heart attacks, and strokes in women. It focuses on the time around menopause when estrogen production stops, which is linked to a higher risk of these conditions. The study will follow 200 women from before menopause to at least 10 years after, using advanced methods to observe changes in blood vessels, the heart, and the brain, along with microRNA analysis of blood and tissue samples. Participants will be observed over a long period with repeated assessments before menopause and at 1, 3, 5, 10, and 20 years after menopause. These assessments include invasive and non-invasive measures of vascular function, as well as monitoring changes in skeletal muscle proteins and RNA expression from muscle and blood samples. Blood pressure will also be tracked regularly during this time. Women involved in the study will undergo detailed cardiovascular and biological evaluations at various time points throughout the study. This includes tests of blood vessel function, muscle tissue analysis, and blood sample collections. The researchers will also monitor blood pressure and other health indicators to understand the long-term impact of menopause on cardiovascular health. The total participation may last over 20 years, providing extensive data on how menopause influences disease risk over time.

This research aims to evaluate the effect of equol, a compound produced by gut bacteria from soy-related diets, on menopausal symptoms in women aged 40 to 60. The study hypothesizes that women who produce equol may experience milder menopausal symptoms compared to those who do not. Equol has estrogen-like activity, which is thought to influence these symptoms. Participants will consume a soy protein bar after dinner on the first day of the study. Urine samples will be collected before and after consuming the soy bar to measure equol concentration. The samples will be analyzed to assess the relationship between equol production and menopausal symptoms. During the study, participants will have their height, weight, and blood pressure measured and will complete questionnaires about their demographics, menopausal symptoms, diet, and physical activity. Urine samples will be collected on two consecutive mornings and sent for analysis. The main outcome measured is the urine equol concentration before and after soy bar consumption, helping researchers understand equols role in menopausal symptoms.

Researchers are evaluating and comparing the immune modulation effects of three FDA-approved CDK46 inhibitorspalbociclib, ribociclib, and abemaciclibcombined with letrozole as neoadjuvant treatment for early estrogen-receptor positive ERHER2-negative breast cancer. While all three inhibitors have shown progression-free survival benefits in advanced breast cancer, differences in overall survival might be influenced by their varying effects on the tumor microenvironment and immune system. This Phase 2 randomized study aims to provide a head-to-head comparison of these effects in the same trial. Participants will receive one of three treatment combinations palbociclib with letrozole, ribociclib with letrozole, or abemaciclib with letrozole. These CDK46 inhibitors are given alongside endocrine therapy before surgery over a 12-week period. Tissue, blood, and stool samples will be collected before treatment, two weeks after starting treatment, and after 12 weeks at surgery to analyze immune-related changes through RNA sequencing of breast tumors. During the study, researchers will monitor participants for immune response changes and adverse events. The primary outcome is the change in immune-related gene expression after treatment, assessed through RNA sequencing over an average follow-up of three years. Safety will be assessed over four months. Participants organ function and performance status will be evaluated before and during treatment to ensure safety and compliance with study procedures.

Researchers are studying Canadian women who are in menopause and experiencing bothersome hot flashes and night sweats, also called vasomotor symptoms VMS. The study focuses on women whose own doctors have prescribed the drug fezolinetant as part of their usual health care. The main goal is to find out if fezolinetant improves these symptoms after 12 weeks, with additional aims to observe benefits over a full year, including better sleep and overall wellbeing. Participants will take oral tablets of fezolinetant every day for up to 52 weeks. This observational study records information about how the drug is used in real-life clinical settings, without the study team deciding on treatment. The study also gathers data on treatment satisfaction, adherence, reasons for starting or stopping the drug, and any safety concerns. Other menopausal treatments taken alongside fezolinetant are tracked as well. Women in the study will provide information through questionnaires and reports at various times during the year, including baseline and weeks 4, 12, 24, and 52. These assessments cover symptom improvement, sleep quality, treatment satisfaction, and side effects. Safety events are monitored up to 56 weeks. All participant data helps researchers understand the effects and use of fezolinetant during routine care, with no extra treatments provided by the study.

Researchers are studying sexual health and vulvovaginal health in premenopausal and perimenopausal women with hormone receptor positive breast cancer who are receiving ovarian suppression. The study aims to find out if starting sexual health counseling and using non-hormonal moisturizers early can prevent or reduce side effects like vaginal dryness and sexual dysfunction. This is compared to the usual care approach where treatment begins only after symptoms appear. Participants will be randomly assigned to one of two groups. One group will receive sexual health counseling and start using non-hormonal moisturizers 3 to 5 times weekly from the beginning of ovarian suppression, along with education about vaginal dilators and a consultation with a pelvic floor physical therapist. The other group will start treatment only after developing symptoms and will receive a list of recommended moisturizers to purchase themselves. Both groups will complete various questionnaires to monitor sexual health and vaginal symptoms. During the study, participants will be monitored through surveys and subjective and objective assessments of vaginal dryness and sexual function. Researchers will track the number of participants who have a score of 4 or higher on the Vaginal Assessment Scale within one year. The study includes regular completion of validated questionnaires and a weekly diary about moisturizer use. The total participation time corresponds with one year of follow-up to evaluate the interventions impact.

This research aims to evaluate how accurately a wearable device can detect and characterize symptoms experienced by women during perimenopause and menopause. The study focuses on symptoms such as hot flashes, night sweats, anxiety, and sleep quality, comparing the devices data with self-reported symptoms recorded daily through an app. The goal is to understand how well the devices algorithm matches participants own reports of their symptoms. Participants will use IndentifyHers Peri, a commercial, non-invasive wearable sensor designed to monitor the frequency and severity of perimenopausal symptoms. They will wear this device continuously while also completing daily electronic diaries and questionnaires about stress, anxiety, and sleep for a period of two weeks. This combination allows researchers to compare the devices measurements with participants self-reports. During the study, participants will be asked to maintain their usual lifestyle habits, including diet, exercise, supplements or medications, and sleep patterns. Researchers will collect data from the wearable device, daily app questionnaires, and stress and sleep assessments. The main outcomes measured are the accuracy of the devices algorithm in tracking vasomotor symptoms, anxiety, sleep quality, and overall perimenopausal symptoms during the 14-day study period. The study is observational and virtual, with involvement lasting approximately two weeks.

Researchers are investigating the effects of a high-fat mixed meal containing a whey protein-enriched milk fat globule membrane MFGM supplement on heart and brain health markers in middle-to-older-aged, postmenopausal women who are overweight and at moderate risk for cardiovascular disease. This randomized, single-blind, placebo-controlled crossover study aims to understand how this specific nutritional ingredient influences post-meal responses related to cardiovascular and cognitive health. Participants will attend two approximately 8-hour visits. During each visit, they will consume a high-fat meal containing about 75 grams of refined palm oil fat supplemented either with a whey protein-enriched MFGM powdered ingredient or a placebo whey protein-based powdered ingredient without MFGM. The meals are matched for energy and protein content and given in random order with a washout period of at least 21 days between visits. During each visit, researchers will take body measurements and periodically assess heart health through blood pressure and blood vessel stiffness tests. Blood samples will be collected at multiple time points before and after the meal, over a 6-hour period, to measure changes in blood fats, glucose, insulin, and inflammatory markers. Participants will also complete computer-based tests to assess mood and cognitive function. The study will monitor how the supplement affects these heart and brain health markers in the hours following a meal.