Postmenopausal Women

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 find out if men with prostate cancer who experience hot flashes due to their Androgen Deprivation Therapy (ADT) will consistently use a smartwatch to track their health and log these symptoms. The study focuses on comparing data recorded by the smartwatch with daily surveys about the participants' hot flashes to better understand their experiences during ADT treatment. Participants will receive an EmbracePlus smartwatch and be trained on how to log hot flashes by pressing a button on the watch at the start and end of each event. They will be asked to wear the smartwatch continuously, except when charging, for 4 weeks. During this time, they will also receive up to four daily electronic surveys via text message to report the frequency and experience of their hot flashes. Throughout the study, biometric data will be collected via Bluetooth from the smartwatch to a smartphone app and then to a secure cloud server for monitoring. Participants will have periodic check-in calls and complete an end-of-study survey. The main outcomes measured include daily watch wear duration, days with logged hot flashes, and how closely the smartwatch logs match the daily surveys. Overall participation lasts 28 days.

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 safety and early effects of vitamin K2 (menaquinone-7, MK-7) supplementation in adults aged 40 to 75 years with low bone mineral density, including osteopenia or osteoporosis. The study focuses on individuals carrying a specific "unfavorable" variant in the vitamin D receptor (VDR) gene, comparing them to those without this gene variant. The goal is to see if MK-7 supplementation improves bone health and related markers more in the variant group, who may have a reduced response to vitamin D. Participants will receive vitamin K2 (menaquinone-7) at doses of 100 to 200 micrograms per day along with vitamin D3 at 800 to 1000 IU per day for a period of 6 to 9 months. The study has two groups: one with homozygous carriers of the VDR variant and one control group without the variant. Both groups will follow the same supplementation regimen to compare outcomes related to bone health. During the study, participants will be monitored for changes in bone mineral density over 9 months, along with serum osteocalcin levels, bone turnover markers, vitamin D levels, and quality of life measures. Safety and tolerability will be assessed by recording any treatment-related adverse events. Participants will maintain stable diets and exercise routines, and genotyping will confirm their group assignment. Total participation will last up to 9 months with regular assessments.

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 conducting a monocentric observational prospective study to assess how common vertebral fractures are among male patients aged 50 years and older who undergo chest-abdomen CT scans for reasons other than bone metabolic diseases. The study aims to use advanced imaging techniques combined with artificial intelligence to identify fractures that may otherwise be unnoticed. Participants will have their CT scans evaluated both by radiologists using automatic 3D reconstruction of the thoracic and lumbar spine and by AI software called NanoxAIHealthVCF from NANO-X IMAGING LTD. The study plans to enroll about 250 patients between March 1, 2025, and February 28, 2026. If one or more vertebral fractures are detected by either method, the patient will be referred for further evaluation in an Endocrinology Unit as part of standard care. Participants will provide clinical, body measurement, and medical history data at the time of their CT scan. The study involves only one evaluation during the CT scan visit, with no additional study visits unless a fracture is found. The main outcome measured is the number of vertebral fractures detected by the combined AI and 3D reconstruction method during the specified enrollment period. The study is observational, so no experimental treatment is given, and patient care follows usual medical practices.

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 evaluating the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, comparing results with those from the FREEDOM substudy. This study focuses on women aged 60 to 90 years who have a BMD T-score between -4.0 and -2.5. It aims to assess ACC's impact both with and without the addition of Denosumab treatment, an osteoporosis therapy, in an open-label setting. Participants are assigned to one of two groups: the A arm includes women who meet National Health Insurance (NHI) criteria for Denosumab and receive 5 ACC tablets daily plus a 60 mg Denosumab injection every 6 months; the B arm includes women who do not meet NHI criteria or prefer not to receive Denosumab and take 5 ACC tablets daily only. All participants with certain vitamin D levels receive daily vitamin D3 supplements. The study spans 7 clinic visits over 24 months, including screening, treatment start, and follow-up visits. During visits, researchers perform BMD assessments and blood draws at baseline and months 1, 6, 12, and 24. They monitor changes in lumbar spine BMD as the primary outcome, along with overall BMD and bone turnover markers over 2 years. Participants are expected to comply with vitamin D intake limits and complete study procedures, allowing researchers to evaluate the effects of ACC with or without Denosumab on bone health.

Researchers are evaluating the clinical efficacy, safety, and immune response of the drug 9MW0311 compared to Prolia® in Chinese postmenopausal women with osteoporosis who are at high risk for fractures. This Phase III, multicenter, randomized, double-blind study aims to better understand how these treatments affect bone density over a year. The study focuses on women aged 50 to 80 years with osteoporosis and additional risk factors for fractures. Participants are randomly assigned to one of two groups to receive either 9MW0311 or Prolia®, both given as a 60 mg denosumab injection under the skin every six months for a total of two doses over 12 months. The main goal is to measure the percentage change in bone mineral density (BMD) of the lumbar spine after one year. Secondary measures include changes in BMD at other bone sites, bone turnover markers, fracture occurrence, and assessment of any side effects or immune reactions. Throughout the study, participants will undergo bone density scans, blood tests for bone markers and immune response, and monitoring for fractures and adverse events at various time points up to 12 months. Safety assessments include vital signs, physical and oral exams, lab tests, and heart monitoring. The study tracks participants' health and treatment effects carefully to evaluate both drugs' performance and tolerability over the course of the year.