Vaginal Atrophy

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 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 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.

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.

Researchers are studying the effects of conjugated estrogensbazedoxifene CEBZA on mood, specifically depression and anxiety, in women who are peri- or early postmenopausal. The study focuses on how estrogen fluctuations during menopause might contribute to these symptoms and explores whether treatment with CEBZA can improve mood and sleep. This is a pilot study involving 30 women seeking treatment for these symptoms. Participants will take a study medication called Duavive, which combines 0.45 mg conjugated estrogens and 20 mg bazedoxifene, once daily for 16 weeks. The study does not involve a placebo or comparison group and lasts for the full 16 weeks of treatment. The goal is to observe changes in mood and sleep during this period. During the study, researchers will regularly assess depressive and anxiety symptoms at 4, 8, 12, and 16 weeks after starting treatment. They will also monitor menopause symptoms and sleep quality, including total sleep time, time to fall asleep, and awakenings after sleep onset. Participants will be closely followed to measure these outcomes and track any changes over the 16 weeks of treatment.

Researchers are studying how changes in the gut microbiome relate to hormonal changes during womens ageing, especially throughout menopause. This observational study focuses on healthy women aged 40 to 64 living in Portugal. It aims to understand how menopause affects long-term health by examining gut microbiome, hormone levels, and markers of chronic low-grade inflammation, to help develop better prevention strategies for womens health. Participants are grouped by menopausal stage premenopausal with regular periods, perimenopausal with irregular periods and some menopausal symptoms, and menopausalpostmenopausal with no menstruation for 12 months. Women will provide stool and blood samples and complete questionnaires about their health, lifestyle, diet, and menopausal symptoms. The study collects data over 10 years, with baseline and follow-up assessments every two years. During the study, participants will be assessed for gut microbiome composition and function, hormone levels, inflammation markers, menopause-related symptoms, nutrition, physical activity, sleep habits, and stress levels. These evaluations help researchers identify microbiome and blood biomarkers linked to menopause and ageing. Participation involves regular sample collection and questionnaires, with ongoing monitoring to support personalized risk assessment and prevention in womens health.

Researchers are evaluating the effects of relaxation and breathing training delivered by a physiotherapist compared to an artificial intelligence-assisted system in postmenopausal women with chronic musculoskeletal pain. The study focuses on women aged 45 to 65 who are experiencing pain related to the natural decline in estrogen levels after menopause, which affects muscle and bone health as well as quality of life. This randomized controlled trial aims to compare traditional and AI-based relaxation methods to support symptom management in this population. Participants will be randomly assigned to one of three groups physiotherapist-led face-to-face sessions, AI-assisted training through prerecorded audio exercises on a smartphone or tablet, or a control group receiving general information without structured training. The interventions last eight weeks with sessions three times per week, each about 30 minutes. The physiotherapist-led group receives supervised training, while the AI group follows exercises created and voiced by AI technology and logs their practice daily. The control group continues their usual routines during the study period. Participants undergo assessments at the start and end of the eight weeks to measure pain intensity, pressure pain threshold, menopause-specific quality of life, musculoskeletal symptoms, psychological state, sleep quality, dyspnea, and satisfaction with the program. The study monitors these outcomes to understand how each training method affects pain, physical function, sleep, and psychological well-being. The trials findings aim to inform accessible and cost-effective approaches to improve daily functioning in postmenopausal women.