Menopause

Perimenopause is the phase before menopause where women experience symptoms like hot flushes, night sweats, mood swings, anxiety, sleep problems, fatigue, and trouble with memory or concentration. These symptoms can be frequent and intense, affecting quality of life. Despite growing awareness, there is limited research on how diet and supplements impact menopause symptoms. This study investigates the effects of 12 weeks of magnesium supplementation on symptoms, cognition, sleep, and psychological well-being in perimenopausal women. The study compares two groups: one taking a magnesium hydroxide supplement and the other a placebo, both for 12 weeks. Each participant will take two capsules daily of either magnesium hydroxide or placebo. The trial is randomized and triple-blinded to fairly assess the effects of magnesium. The treatment period lasts 84 days with assessments conducted at baseline, 6 weeks, and 12 weeks. Participants will complete memory and cognitive tasks, such as numeric and alphabetic working memory tests, recognition tasks, and the Corsi blocks task, at three time points. They will also fill out questionnaires measuring menopause-specific quality of life, depression, anxiety, stress, mood, and sleep quality. These measures will help researchers understand how magnesium may influence cognition, psychological health, and sleep during perimenopause. The study is led by Northumbria University and plans to end in August 2026.

Perimenopause is a transition phase before menopause, marked by symptoms such as mood changes, anxiety, sleep problems, hot flushes, night sweats, fatigue, and cognitive challenges. These symptoms can significantly impact women's quality of life. Although awareness of menopause has grown, research on nutritional approaches to manage these symptoms remains limited. This study aims to evaluate the impact of a 12-week multi-vitamin/mineral and herbal supplement on perimenopause symptoms, memory, concentration, sleep, and psychological well-being compared to a placebo. Participants will be randomly assigned to one of two groups: one taking a placebo capsule daily for 84 days, and the other taking a multi-vitamin/mineral supplement daily for the same duration. The supplement includes herbal extracts and vitamins recommended by menopause societies. The study will compare the effects of these supplements on symptoms and cognitive function over the 12-week period. Throughout the study, participants will be assessed at the start, at 6 weeks, and at 12 weeks. Assessments include various memory and cognitive tests such as numeric and alphabetic working memory, 3-back task, word and picture recognition, as well as questionnaires on menopause quality of life, depression, anxiety, stress, mood, and sleep quality. The study monitors changes in these areas to understand the supplement's effects on perimenopausal women aged 40 to 60 years.

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 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 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 intervention's impact.