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.

This trial studies the effect of pollen extracts on menopausal symptoms in healthy women aged 45 to 65 years who experience moderate menopausal symptoms. It aims to compare changes in symptom severity measured by the Menopause Rating Scale (MRS) over 36 weeks among women taking Graminex Water Soluble Pollen Extract (WSPE), Graminex Lipid Soluble Pollen Extract (LSPE), or a placebo. The study is a randomized, triple-blind, placebo-controlled clinical trial sponsored by Graminex LLC. Participants will be randomly assigned to receive either WSPE standardized to 6% amino acids, LSPE standardized to 7% phytosterols, or a placebo. These dietary supplements will be taken over a 36-week period, during which menopausal symptoms will be tracked. The trial includes assessment at multiple timepoints to monitor changes in overall menopausal symptom severity as well as specific symptom domains such as somatic, psychological, and urogenital symptoms. Throughout the study, participants will complete the MRS questionnaire to rate their menopausal symptoms at baseline and at weeks 6, 12, 24, and 36. Researchers will evaluate symptom changes to understand the differences between the pollen extracts and placebo. The study also monitors sleep disturbance changes and includes safety assessments. Participation involves regular study visits and symptom assessments over the 36-week treatment period.

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 equol's role in menopausal symptoms.

Researchers are evaluating and comparing the immune modulation effects of three FDA-approved CDK4/6 inhibitors—palbociclib, ribociclib, and abemaciclib—combined with letrozole as neoadjuvant treatment for early estrogen-receptor positive (ER+)/HER2-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 CDK4/6 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 intervention's 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 use of autologous adipose tissue-derived mesenchymal stem cells (AD-MSCs) to improve sexual function in women with hormone deficiency and sexual function impairment. This phase II trial follows earlier findings that AD-MSC therapy was safe and showed potential to enhance sexual quality of life, as indicated by improvements in the Female Sexual Function Index (FSFI). The study focuses on hormone levels such as follicle-stimulating hormone (FSH) and estradiol (E2), which are important in female sexual health. Participants are randomly assigned to one of two groups receiving two intravenous infusions of their own AD-MSCs. Group A receives infusions on day 0 and day 90 (plus or minus 7 days), while group B receives infusions on day 180 (plus or minus 14 days) and day 270 (plus or minus 14 days). The dose is 1.0 x 10^6 cells per kilogram of body weight, and cells are prepared and infused over 30 minutes. During the study, participants will have their hormone levels (FSH and E2) and quality of life measured using FSFI and The Utian Quality of Life Scale at 1, 3, 6, and 12 months after the first infusion. Safety will also be monitored at these times. The trial runs until December 2025, with ongoing assessment to understand the therapy's impact on sexual function and overall quality of life in women aged 40 to 65 years.

Researchers are studying the effects of conjugated estrogens/bazedoxifene (CE/BZA) 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 CE/BZA 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 women's 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 women's health. Participants are grouped by menopausal stage: premenopausal with regular periods, perimenopausal with irregular periods and some menopausal symptoms, and menopausal/postmenopausal 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 women's health.