[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"genitourinary-syndrome-of-menopause\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:genitourinary-syndrome-of-menopause":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,44,75,111,138,158,180,203,233,254,278,299,321,344,373,395,416,441],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100636279","determining-the-extent-of-the-genitourinary-syndrome-of-menopause-burden-in-breast-cancer-survivors-100636279",false,"NCT07563621","Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors","Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors: a Cohort Study","V-light cohort","Inclusion Criteria:\n\n* Women diagnosed with breast cancer stage 0, I, II, and III\n* Prior to CT\u002FET, receiving only one of both (no combination)\n* Age 18 years or above\n* Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)\n* Dutch-speaking (be able to understand the informed consent and study-related questionnaires)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Concomitant CT and ET treatment\n* Structural restorative therapies, such as photobiomodulation therapy (PBM) and fractional CO₂ laser treatment, are not permitted during the study period. During the study period, only symptomatic treatment of GSM (e.g., vaginal lubricants or moisturizers) will be allowed",true,"FEMALE","18 Years",{"count":21,"type":22},264,"ESTIMATED","12 Months","OBSERVATIONAL","Breast cancer survivors (BCS) often face unique challenges during and after treatment, including the onset of menopause-related symptoms. Genitourinary Syndrome of Menopause (GSM) is a common concern in BCS undergoing endocrine therapy (ET). It is a chronic condition caused by estrogen deficiency, leading to vaginal and urinary symptoms such as dryness, irritation, pain during intercourse, recurrent infections, and urinary urgency.\n\nThe prevalence of GSM in BCS varies widely depending on factors such as the type of ET, individual patient characteristics, and the duration of treatment. As such, the prevalence of GSM in BCS can range from 13% to 95.2%. A recent systematic review performed by part of the investigators of this study concludes that GSM is a significant problem for breast cancer patients. However, most studies lack a control group, limiting the results' validity. Therefore, this study aims to determine the extent of the GSM burden in BCS using a prospective, controlled cohort study. This study will compare breast cancer patients receiving endocrine therapy (ET) with those undergoing chemotherapy (CT), as CT may also induce GSM-like symptoms. In addition, a comparison will be made with healthy controls.\n\nFor this study, two groups of participants are included: women with breast cancer and a healthy control group without breast cancer. Within the breast cancer group, a distinction is made between women receiving chemotherapy only and women undergoing hormone therapy only. All participants complete questionnaires. The control group completes these questionnaires once, whereas women with breast cancer are asked to complete the same questionnaires at multiple time points during their treatment and follow-up. This longitudinal approach allows us to assess how potential symptoms evolve over the course of treatment. By comparing responses between both groups, a clearer understanding of which symptoms occur more frequently in women with breast cancer as a consequence of their treatment can be obtained.",[27,28,29,30],"Genitourinary Syndrome of Menopause (GSM)","Breast Cancer","Vulvovaginal Atrophy","Genitourinary Syndrome of Menopause","RECRUITING","2026-04-29",{"date":34,"type":35},"2026-05-04","ACTUAL",{"date":37,"type":35},"2026-03-05",{"date":39,"type":22},"2028-08-31",{"name":41,"class":42},"Jessa Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":17,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100583257","eryag-laser-combined-with-vaginal-estriol-for-genitourinary-syndrome-of-menopause-100583257","NCT06873971","Er:YAG Laser Combined With Vaginal Estriol for Genitourinary Syndrome of Menopause","Effects of Erbium:YAG Laser Combined With Vaginal Estriol Therapy in Postmenopausal Women With Genitourinary Syndrome of Menopause: A Protocol for a Randomised, Double-blind Controlled Trial","Inclusion criteria\n\n* Postmenopausal women (45-70 years of age).\n* At least one of moderate symptom of GSM (vaginal dryness, burning sensation, dyspareunia, and persistent leukorrhea), defined by ≥ 4 on Visual Analog Scale (VAS) ranging from 0 to 10.\n* Vaginal pH ≥5.0 at baseline assessment.\n* Not having undergone hormone replacement therapy (vaginal or systemic) in the previous six months.\n* No use of vaginal moisturizers in the previous 30 days.\n* Demonstrated capacity and willingness to provide written informed consent and adhere to study protocols.\n\nExclusion criteria\n\n* Vaginal or vulvar energy-based interventions (e.g., laser, radiofrequency) in the previous six months.\n* Abnormal cervical cytology, specifically ASCUS, LSIL, or HSIL, documented in the previous six months.\n* Systemic corticosteroid therapy administered in the previous 90 days.\n* Body mass index (BMI) ≥35 kg\u002Fm².\n* Presence of abnormal uterine bleeding in the previous 30 days.\n* History of vaginal surgery in the previous 180 days or grade II or higher uterine prolapse (POP-q).\n* History of malignant neoplasms or exposure to vaginal radiotherapy.\n* Diagnosis of severe liver or kidney disease, autoimmune disease, or severe psychiatric disorder.","45 Years","70 Years",{"count":54,"type":22},60,"INTERVENTIONAL",[57],"NA","Chronic hypoestrogenism in postmenopausal women significantly impacts the urogenital epithelium, leading to Genitourinary Syndrome of Menopause (GSM) and increasing susceptibility to gynecological infections due to vaginal pH elevation. Therapies using the Erbium:YAG (Er:YAG) 2940nm laser and low dose topical estrogen have demonstrated efficacy in improving vaginal trophism and restoring microbiota balance.\n\nThis randomised, double-blind clinical study aims to assess the effects of combining Er: YAG laser therapy with vaginal estriol compared with estriol therapy alone in postmenopausal women with GSM. Sixty patients will be recruited and randomly assigned to two groups. All participants will receive low-dose topical estrogen therapy (estriol cream ) for 14 days, followed by twice-weekly applications until completing three laser sessions at four-week intervals. Group 1 (Sham) will receive the laser with minimal fluence (0.5J\u002Fcm²) applied to maintain blinding (auditory cues) below the threshold for biological tissue, while Group 2 , will undergo active laser treatment.\n\nInclusion criteria include age 45-70 years, vaginal pH ≥5, absence of hormone therapy or energy-based intimate treatments for 180 days, and moderate vaginal atrophy symptoms (SCORE \\>4). Exclusion criteria include abnormal cervicalvaginal cytology in the last six months, corticosteroid therapy within 90 days, and BMI ≥35kg\u002Fm².\n\nAssessments will occur at Baseline, 30 days after each laser session and 4 months after the third laser application. The primary outcome is the Vaginal Health Index (VHI), while secondary outcomes include GSM symptom evaluation via the Visual Analog Scale, vaginal microbiota analysis through 16S gene sequencing, and quality-of-life and sexual health questionnaires. Statistical analysis of the groups will be performed using SPSS version 22.0. For analytical statistics, repeated measures ANOVA will be used for continuous data, and non-parametric tests for repeated measures, such as the Friedman test, when appropriate. A p-value \\\u003C0.05 will be considered statistically significant.",[30],[61,62,63,64,65],"Genitourinary syndrome of menopause","postmenopausal women","Erbium: YAG laser","vaginal microbiome","vaginal estriol","2026-04-20",{"date":68,"type":35},"2026-04-23",{"date":70,"type":35},"2025-12-10",{"date":72,"type":22},"2026-12-31",{"name":74,"class":42},"University of Nove de Julho",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":18,"minAge":83,"maxAge":52,"enrollmentInfo":84,"targetDuration":4,"studyType":55,"phases":86,"briefSummary":87,"conditions":88,"keywords":98,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":43},"100590048","changes-in-the-impact-of-genitourinary-syndrome-of-menopause-with-a-novel-nonhormonal-vulvovaginal-gel-assessed-by-proms-100590048","NCT06962345","Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.","Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial. Part of STOP GSM PROJECT.","STOPGSMP","Inclusion Criteria:\n\n* Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination with a Vaginal Health Index ≤15).\n* Patient must be postmenopausal with at least 1 year without a menstrual period.\n* Patient must consider that her quality of life is affected by GSM symptoms\n* Patient not followed due to any gynecological disease.\n* All participants must be able to understand and to fill in the self-reported questionnaires.\n\nExclusion Criteria:\n\n* Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning.\n* Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone products within 4 weeks, neither prescription nor non-prescription therapies for GSM, including topical vaginal non-hormonal lubricants or moisturizers for the last week.\n* Patients with history of vulvar, vaginal and\u002For cervical malignancy.\n* Patients having received radiotherapy treatment in the pelvic and\u002For genital region.\n* Patients with any type of disease that causes alteration of collagenogenesis.\n* Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months.\n* Patients having received laser and\u002For radiofrequency treatment for handling genital atrophy or other pelvic floor dysfunctions.\n* Patients with active urinary and\u002For genital tract infection.\n* Patients with history of malignant neoplasm of the urinary system.\n* Patients with severe stress urinary incontinence (Sandvik test score equal to or greater than 8).\n* Patients with diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification.\n* Patients with medical or surgery history that, at the investigator's discretion, does not allow participation in the study.\n* Patients with any other condition that, at the investigator's discretion, implies that the patient is unable to understand the implication of participating in the study and\u002For following the established procedures.","40 Years",{"count":85,"type":22},80,[57],"The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess changes impact of GSM symptoms.",[89,90,30,91,92,93,94,95,96,97],"Vulvar Atrophy","Vulvovaginal Signs and Symptoms","Quality of Life","Menopause Related Conditions","Dyspareunia","Urinary Incontinence, Urgency-frequency","Sexual Function","Women´s Health","Vaginal Dryness",[30,90,99,91,100,96],"Patient Reported Outcome Measures","Day-to-Day Impact of Vaginal Ageing","2026-03-25",{"date":103,"type":35},"2026-03-30",{"date":105,"type":35},"2024-01-08",{"date":107,"type":22},"2026-12",{"name":109,"class":110},"Mucosa Innovations, S.L.","INDUSTRY",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":55,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100512487","valor-vaginal-atrophy--long-term-observation-of-recovery-100512487","NCT05953090","VALOR: Vaginal Atrophy & Long-term Observation of Recovery","VALOR","Inclusion Criteria:\n\n* Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus\n* Continuous vulvovaginal symptoms\n* Access to smartphone and tablet, laptop or computer\n* Access to a valid email address\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Patient unable to apply topical device\n* Allergy or intolerance to ingredients or excipients of the formulation of studied products\n* Systemic hormonal therapy started less than 30 days before baseline\n* Systemic corticosteroids ongoing treatment or used within the last 30 days before baseline\n* Ongoing topical HRT or corticosteroid treatment for the indication under investigation\n* Topical HRT or corticosteroid treatment used for the indication under investigation within the last 30 days before baseline",{"count":119,"type":22},2000,[57],"Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.",[123,124,30,125,126,127],"Atrophic Vaginitis","Vaginal Atrophy","Lichen Sclerosus of Vulva","Lichen Planus of Vulva","Lichen Simplex of Vulva (Disorder)","2026-02-19",{"date":130,"type":35},"2026-02-20",{"date":132,"type":35},"2023-10-30",{"date":134,"type":22},"2028-12",{"name":136,"class":110},"Stratpharma AG",14,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":55,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100490959","silicone-gel-vs-estrogen-vaginal-cream-for-the-management-of-genitourinary-syndrome-of-menopause-100490959","NCT05672901","Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause","Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial","VITAL-E","Inclusion Criteria:\n\n* Able to provide informed consent\n* Confirmed postmenopausal age\n* Diagnosed genitourinary syndrome of menopause\n* Access to a smartphone, tablet or computer, and to a functional email address.\n\nExclusion Criteria:\n\n* Contraindication for the use of estrogen therapy\n* Unable to provide informed consent\n* Patient unable to apply topical device\n* Allergy or intolerance to ingredients or excipients of the formulation of studied products",{"count":147,"type":22},100,[57],"The goal of this randomized controlled trial is to test the efficacy of StrataMGT in the management of Genitourinary Syndrome of Menopause (GSM) compared to estrogen therapy. The main question it aims to answer is:\n\n\\- Will StrataMGT be non-inferior regarding patient quality of life compared to standard of care?\n\nParticipants will use either StrataMGT or estrogen vaginal cream to treat GSM for 3 consecutive months. After the baseline assessment, participants will be assessed monthly for quality of life, clinical signs, symptoms, pathology and adverse reactions.",[30],{"date":130,"type":35},{"date":153,"type":35},"2023-04-04",{"date":155,"type":22},"2026-09",{"name":136,"class":110},3,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":55,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":43},"100569202","vaginal-changes-after-co2-laser-100569202","NCT06691178","Vaginal Changes After CO2 Laser","Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT\u002FOCTA\u002FOCE Endoscopy, a Randomized Controlled Trial","OCTRCT","Inclusion Criteria:\n\n1. Birth sex: female\n2. Desire for vaginal laser therapy for GSM\n3. Age \\>=18 years old\n4. Willingness to forego other treatments for GSM within the study period\n5. Diagnosed as postmenopausal (either by surgical removal of ovaries or natural progression defined as no periods in 1 year)\n\nExclusion Criteria:\n\n1. History of pelvic radiation\n2. On hormone replacement therapy in the prior 3 months\n3. Not able or willing to follow study instructions\n4. Current diagnosis of recurrent UTIs",{"count":167,"type":22},50,[57],"Genitourinary syndrome of menopause (GSM) occurs due to a decline in estrogen levels as a woman approaches menopause. The syndrome negatively impacts women's quality of life and is characterized by vaginal dryness, burning, diminished lubrication, painful intercourse and urinary symptoms such as frequency and urgency. GSM is diagnosed by symptom assessment and physical exam, with current mainstay of treatment being vaginal estrogen. Women with a history of breast cancer, gynecologic cancer, or venous thromboembolism may not be candidates for hormonal therapy. Thus, there has been a quest for effective non-hormonal forms of treatment for GSM. The use of vaginal CO2 laser treatment for GSM has shown promising results.\n\nIn this study, we aim to use long-wavelength optical coherence tomography\u002Fangiography\u002Felastography (OCT\u002FOCTA\u002FOCE) to document changes that occur in the vaginal epithelium during menopause as well as after treatment for GSM. OCT is a well-studied technology and is widely used in Dermatology and Ophthalmology. In collaboration with the Beckman Laser Institute (BLI), we have developed a non-invasive vaginal probe (HS# 2017-3686). The probe has subsequently been used in previous studies to validate measurements in the vaginal epithelium (HS# 2019-5446). A previous RCT compared clinical response to laser therapy to a control group that received a low level of laser therapy. The study also did not examine histology. This will be a randomized controlled trial in which women will be enrolled into one group receiving laser therapy and compared to a true sham group that will not receive laser therapy at all. Response will be measured primarily by OCT device as well as optional vaginal biopsies. There will also be questionnaires and exam of the vaginal tissue using the VHI.",[30],"2026-02-16",{"date":173,"type":35},"2026-02-18",{"date":175,"type":35},"2023-05-01",{"date":177,"type":22},"2027-07-01",{"name":179,"class":42},"University of California, Irvine",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":193,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":4},"100604589","impact-of-oral-supplementation-with-bioactive-collagen-peptides-and-other-functional-ingredients-100604589","NCT07151482","Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients","Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients on Quality of Life, Related to Vaginal Atrophy and Urinary Incontinence Inwomen With Genitourinary Syndrome of Menopause (GSM)","Maicol","Inclusion Criteria:\n\n* Menopausal women (at least 12 months since last menstrual period or bilateral oophorectomy)\n* Patients with Genitourinary Syndrome and the presence of vulvovaginal atrophy\u002Fvestibular trophism alteration (defined as Vaginal Health Index - VHI - less than 15; and Vestibular Trophic Health Score - VeTH - more than 5) and\u002For initial urinary incontinence based on patient history (stress incontinence , urge incontinence, nicturia reported by patients,) positive IU tests (Stamey score 1: loss of urine with sudden increase in abdominal pressure such as from coughing, sneezing, or laughing) and on a standardized stress test provocation \\[(cough test supine and in a standing position with a full bladder (300 ml)\\] in healthy post-menopausal women and\u002For positive OABSS score for overactive bladder.\n* Patients willing to provide Informed consent to participate in the study.\n* Women aged between 45 and 65 years.\n\nExclusion Criteria:\n\n* Renal insufficiency or sever nephropathy.\n* In case of known hypersensitivity to one or more of the components contained in the food supplement.\n* Active or recent (30 days) genitourinary tract infection.\n* Abnormal uterine bleeding.\n* Use of lubricants or any other local or systemic preparations, within the 30 days prior to the study.\n* Genital prolapse (grade II - III according to the Pelvic Organ Prolapse-Quantification, POP-Q, system classification).\n* Serious or chronic condition that could interfere with study compliance.\n* Treatment with hormones or other medicines to relieve menopausal symptoms within the 3 months prior the study.","65 Years",{"count":190,"type":22},43,"Genitourinary Syndrome of Menopause (GSM), characterized by vaginal dryness, pain, urinary incontinence, and other symptoms, can be mitigated through both hormonal and non-hormonal treatments. Collagen peptides have shown promising results in improving skin, cartilage, and exhibiting antioxidative activities in studies. This study evaluates changes of quality of life and sexual function, related to vulvovaginal atrophy (VVA) and initial urinary incontinence (UI) in women with GSM symptoms, with the intake of a daily oral food supplement containing 2.5 g of Bioactive Collagen Peptides (BCP®) and other functional ingredients over a 16-week period . This can represent a new therapeutic option for these patients, particularly when hormonal therapy is not an option.",[30],"NOT_YET_RECRUITING","2025-08-25",{"date":196,"type":35},"2025-09-03",{"date":198,"type":22},"2025-09-01",{"date":200,"type":22},"2028-02-28",{"name":202,"class":42},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":188,"enrollmentInfo":210,"targetDuration":4,"studyType":55,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":43},"100570650","effectiveness-of-a-telerehabilitation-program-for-improving-sexual-function-and-reducing-pain-in-menopausal-women-100570650","NCT06710002","Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women","Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women With Dyspareunia: Protocol of a Randomized Clinical Trial.","Inclusion Criteria:\n\n* Female\n* Age from 45 to 65 years.\n* Menopausal\n* Suffer dyspareunia for 3 months of evolution.\n* Willing to complete study questionnaires and informed consent study.\n\nExclusion Criteria:\n\n* Pacemaker or other types of electronic implant.\n* Thrombophlebitis.\n* Skin hypersensitivity or rejection of manual contact.\n* Active or previous treatment with chemotherapy or radiotherapy in the pelvic area.\n* Wounds or burns in the pelvic area.\n* Allergy to nickel and chromium.\n* Other pelvic floor physiotherapy treatments during the study intervention.\n* Other medical and surgical treatments in the pelvic region, such as muscle infiltrations or nerve blocks during the study intervention.\n* Surgical intervention in the pelvic area in the last 3 months.\n* Fibromyalgia.\n* Oncological processes that affect the sacrum.\n* Systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic conditions).\n* Neuromuscular diseases (Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Myasthenia Gravis or spinal muscular atrophy).\n* Myelopathy and Osteomyelitis.\n* Diseases that cause alterations of the central nervous system (traumatic or vascular spinal cord injury).\n* Neurological or metabolic conditions that affect the ability to respond (Diabetes, Parkinson's disease, senile dementia, etc).\n* Serious mental disorder.",{"count":211,"type":22},90,[57],"The aim of this study is to analyze the effectiveness of a telerehabilitation program with respect to a face-to-face physiotherapy protocol in relation to the improvement of sexual function, the reduction of pain and the improvement of the quality of life, in the treatment of menopausal women with dyspareunia.",[215,30,93],"Menopause",[217,218,219,220,221,222,223],"Physiotherapy","Telerehabilitation","face to face treatment","female sexual function","vaginal dilators","manual therapy","capacitive resistive monopolar radiofrequency","2025-05-20",{"date":226,"type":35},"2025-05-23",{"date":228,"type":35},"2025-05-05",{"date":230,"type":22},"2026-03",{"name":232,"class":42},"Instituto Médico Tecnológico SL",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":55,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":43},"100583716","concomitant-treatment-with-topical-hyaluronic-acid-and-high-concentration-oxygen-therapy-vaginal-natural-oxygenation-device---vnod-in-the-improvement-of-symptoms-related-to-genitourinary-syndrome-of-menopause-in-women-with-natural-and-oncological-postmenopause-open-label-single-center-randomize-100583716","NCT06879938","Concomitant Treatment with Topical Hyaluronic Acid and High Concentration Oxygen Therapy (Vaginal Natural Oxygenation Device - VNOD) in the Improvement of Symptoms Related to Genitourinary Syndrome of Menopause in Women with Natural and Oncological Postmenopause: Open-Label, Single-Center, Randomize","Concomitant Treatment with Topical Hyaluronic Acid and High Concentration Oxygen Therapy (Vaginal Natural Oxygenation Device - VNOD) in the Improvement of Symptoms Related to Genitourinary Syndrome of Menopause in Women with Natural and Oncological Postmenopause: Open-Label, Single-Center, Randomized Study","Caress","Inclusion Criteria:\n\n* Informed consent signature\n* Willingness to undergo treatment and follow-up evaluations according to the schedule outlined in the protocol\n* Age \\> 18 years\n\nCohort 1:\n\n* Diagnosis of non-metastatic breast cancer (M0\u002FMx according to TNM system) who have undergone surgical and\u002For chemotherapy and\u002For immunotherapy and\u002For radiotherapy and\u002For endocrine treatment.\n* Postmenopausal women (FSH \\> 30 UIIU\u002FL, E2 \\\u003C 20 pg\u002Fml), either naturally or surgically induced, or iatrogenic post-chemotherapy with absent menstrual cycle for at least 6 months; or premenopausal women on treatment with LHRH analog +\u002F- tamoxifen and\u002For aromatase inhibitor for at least 6 months.\n* At least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the MBS scale).\n* Signs of pelvic static alterations not exceeding POP-Q score 2 (POP-Q).\n\nCohort 2:\n\n* Postmenopausal women (FSH \\> 30 UI\u002FL, E2 \\\u003C 20 pg\u002Fml), with absent menstrual cycle for at least 6 months, or women who have undergone bilateral adnexectomy at least 6 months ago.\n* At least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the MBS scale).\n* Signs of pelvic static alterations not exceeding POP-Q score 2 (POP-Q).\n\nExclusion Criteria:\n\n* Other current therapy aimed at resolving symptoms associated with vulvo-vaginal atrophy, with the exception of the use of lubricants if sexual activity is present;\n* HRT in progress or discontinued for less than 6 months;\n* Ongoing vulvo-vaginal and urinary infections;\n* Bleeding of ndd;\n* Pathological pap-test within the previous 12 months.",{"count":85,"type":22},[57],"The Caress study is a single-center, open-label, randomized controlled trial (RCT) evaluating the efficacy of a combined treatment using topical hyaluronic acid and high-concentration oxygen therapy (Vaginal Natural Oxygenation Device - VNOD) in improving symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women, including those with a history of breast cancer. The primary objective is to assess vaginal dryness improvement one month after treatment, comparing two groups: an experimental group receiving VNOD therapy with hyaluronic acid and a control group using a hyaluronic acid-based gel (Hydeal-D®). Secondary endpoints include the evaluation of additional vaginal symptoms (pain, irritation, itching, sexual health, quality of life) up to six months post-treatment. The study will enroll 80 women (40 with a history of breast cancer and 40 without). Statistical analysis will use chi-square tests and logistic regression to compare symptom severity reduction between the two groups. With a duration of 18 months, the study aims to provide an innovative, non-hormonal treatment option to improve the quality of life for postmenopausal women, particularly those with a history of breast cancer",[30],"2025-03-11",{"date":247,"type":35},"2025-03-17",{"date":249,"type":35},"2023-10-16",{"date":251,"type":22},"2025-12",{"name":253,"class":42},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":55,"phases":263,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":193,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":4},"100578211","phase-4-difference-in-serum-estrogen-level-based-on-methods-of-vaginal-estrogen-application-fingertip-vs-applicator-use-in-post-menopausal-women-100578211","NCT06808347","Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Post-menopausal Women","Inclusion Criteria:\n\n* patients who are postmenopausal for at least 1 year (since their last menses)\n* patients who qualify for treatment with vaginal estrogen cream and are willing to complete the treatment\n* English speaking patients\n* patients should be able to self-apply the vaginal estrogen cream using the applicator method and the fingertip application\n* Patients who are surgically menopausal\n* Military healthcare beneficiary status\n\nExclusion Criteria:\n\n* pre and perimenopausal women\n* contraindication to estrogen therapy (Deep vein thrombosis, history or active cancer)\n* women who are not able to self apply the vaginal estrogen cream\n* vaginal bleeding of unknown origin\n* women currently on hormone replacement therapy or vaginal estrogen therapy","100 Years",{"count":262,"type":22},110,[264],"PHASE4","Study the change in serum estrogen level based on the method of vaginal cream application (applicator vs fingertip application) and Measure patient satisfaction with vaginal estrogen cream application based on the method of application using a validated patient questionnaire (Likert scale).",[267,30],"Postmenopausal Atrophic Vaginitis","2025-01-31",{"date":270,"type":35},"2025-02-05",{"date":272,"type":22},"2025-02-01",{"date":274,"type":22},"2025-09-30",{"name":276,"class":277},"Walter Reed National Military Medical Center","FED",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":55,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":193,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":298},"100575114","intravaginal-negative-pressure-medical-device-for-treatment-of-genitourinary-syndrome-of-menopause-gsm-100575114","NCT06768073","Intravaginal Negative Pressure Medical Device for Treatment of Genitourinary Syndrome of Menopause (GSM)","Clinical Outcomes and Safety of an Intravaginal Negative Pressure Medical Device in the Treatment of Genitourinary Syndrome of Menopause (GSM): A Pilot Study","Inclusion Criteria:\n\n1. Healthy postmenopausal subjects from 1 to 15 years since their last menstrual cycle.\n2. Willingness to refrain from using alternative therapies for treatment of symptoms of GSM, unless medically necessary, through the duration of this study.\n3. Moderate to severe dyspareunia associated with GSM. (i.e., ≥4 on the 11-point patient-reported numeric rated dyspareunia scale).\n4. Subjects who are sexually active (i.e. have had or have attempted to have sexual activity with vaginal penetration within approximately 1 month of screening visit).\n5. Subjects who anticipate engaging or attempting to engage in sexual activity (with vaginal penetration) at least twice a month during the trial.\n6. Vaginal Health Index (VHI) score of less than or equal to 15.\n7. Vaginal pH \\>5.0.\n8. The subject is anatomically suitable to the intravaginal tip as determined by the Investigator.\n9. Normal Papanicolaou test within the past year (or should be done 2 weeks before the trial begins). Subject can ONLY participate on negative results.\n10. Vaginal canal free of any lesions other than symptoms of GSM as determined by the Investigator.\n11. Negative screening for chlamydia, gonorrhea, bacterial vaginosis, trichomonas and yeast.\n12. Willingness and ability to give voluntary written informed consent to participate in the study and comply with protocol requirements.\n13. Willingness to refrain from sexual intercourse for at least 48 hours before all visits and for at least 48 hours after all treatments.\n14. Willingness to stop using current vaginal lubricant, moisturizers or similar and only use the lubricant provided by the clinic.\n15. Willingness to stop using the clinic assigned lubricant for at least 48 hours before all scheduled visits post screening.\n16. Willingness to refrain from any pelvic floor therapy for the duration of the trial.\n17. Willingness to refrain from enrolling in another clinical trial for the duration of this study.\n\nExclusion Criteria:\n\n1. Subjects on Hormone Therapies (HT), systemic or local, or within 6 months of cessation of HT prior to inclusion in the study.\n2. Subjects with bleeding disorders.\n3. Subjects with any sexually transmitted disease.\n4. Subjects on prescribed anticoagulants such as antiplatelets and anticoagulants (Heparin, Warfarin, Clopidogrel, Apixaban, Rivaroxaban).\n5. Any active genital infections.\n6. Abnormal Papanicolaou test within the past year.\n7. Positive pregnancy test or planned pregnancy during the study period.\n8. Complete procidentia or prolapse that in investigator opinion would be unsuitable for probe placement.\n9. Subjects with urogenital sinus (this is when urethral opening is combined with the vagina opening), otherwise the urethral opening will be traumatized potentially resulting in a urinary tract infection (UTI).\n10. Subjects with a compromised immune system.\n11. Subjects who have undergone pelvic irradiation treatment.\n12. Subjects who have undergone off-label procedures such as \"vaginal rejuvenation\" (e.g., laser or thermoablative techniques).\n13. Pelvic surgery within 6 months prior to the start of the study.\n14. Undiagnosed vaginal bleeding.\n15. Subjects with bleeding during screening examination due to friable vaginal mucosa and\u002For very thin epithelial layer, such that investigator determines the VITA AV treatment would be contraindicated.\n16. Subjects receiving chemotherapy or radiotherapy or subjects with any diagnosed gynecological cancers.\n17. History of breast cancer who have had chemotherapy within the last 5 years or are on aromatase inhibitors.\n18. Any general health or anatomical conditions, mental health or social situation which, in the opinion of the investigator, could represent an increased risk for the subject, or the ability of the subject to complete study requirements.\n19. Currently participating or considering participation in any other research of an investigational drug or device. Does not include observational studies.\n20. Subjects that have previously received this treatment as part of a clinical trial.",{"count":54,"type":22},[57],"This pilot study aims to evaluate the safety and effectiveness of the VITA AV Clinical System over a period of up to three months after the last treatment, compared to a sham device. The study focuses on improving vaginal signs and symptoms of Genitourinary Syndrome of Menopause (GSM) in post-menopausal women who experience moderate to severe pain during intercourse (dyspareunia). Long-term follow-up visits will assess the ongoing effectiveness and durability of the treatment, while also collecting safety data.",[30],"2025-01-06",{"date":291,"type":35},"2025-01-10",{"date":293,"type":22},"2025-03-03",{"date":295,"type":22},"2025-11-03",{"name":297,"class":42},"AVeta Medical",2,{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":260,"enrollmentInfo":306,"targetDuration":4,"studyType":55,"phases":307,"briefSummary":308,"conditions":309,"keywords":310,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":319,"locationsCount":43},"100516631","vaginal-co2-laser-therapy-for-genitourinary-syndrome-in-breast-cancer-survivors-100516631","NCT06007027","Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors","Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study","Inclusion Criteria:\n\n* Breast cancer survivor in endocrine therapy\n* Symptomatic genitourinary symdrom of menopause with vaginal discomfort and\u002For dyspareunia\n* Able to read and understand Danish\n* Able to give written informed consent\n\nExclusion Criteria:\n\n* Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system\n* Use of non-hormonal\u002Fhormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively)\n* Use of Chemotherapy (6 months prior to the baseline visit)\n* Acute urinary tract infection or active genital infection\n* History of vaginal reconstructive surgery",{"count":54,"type":22},[57],"This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.",[30],[311,312],"laser","mamma cancer","2024-12-04",{"date":315,"type":35},"2024-12-05",{"date":317,"type":35},"2024-12-01",{"date":103,"type":22},{"name":320,"class":42},"University of Aarhus",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":328,"targetDuration":330,"studyType":24,"phases":4,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":43},"100555184","combination-of-the-vaginal-laser-with-a-moisturizing-and-repairing-niosomal-gel-in-the-treatment-of-genitourinary-syndrome-in-oncology-patients-100555184","NCT06508788","Combination of the Vaginal Laser With a Moisturizing and Repairing Niosomal Gel in the Treatment of Genitourinary Syndrome in Oncology Patients","Combinación Del láser Vaginal Con un Gel Niosomal Hidratante y Reparador en el Tratamiento Del síndrome Genitourinario en Pacientes oncológicas","Inclusion Criteria:\n\n* Patients with an established SGM diagnosis.\n* Patients with a history of neoplasia in whom the use of estrogens as the first alternative for the treatment of GMS is not recommended.\n\nExclusion Criteria:\n\n* Patients with concomitant vulvovaginal pathology.\n* Patients with a diagnosis of pelvic organ prolapse grade II or greater.",{"count":329,"type":22},30,"1 Year","Vaginal laser together with the use of moisturizing and repairing gels could be an effective therapy for the treatment of genitourinary syndrome in women with a history of neoplasia in whom the use of estrogens is not recommended.\n\nThe purpose of this study is to evaluate the effectiveness of vaginal laser together with adjuvant treatment with a hydrating and repairing niosomal gel as a beneficial treatment in this group of patients.",[30],[30,334],"CO2 laser","2024-07-26",{"date":337,"type":35},"2024-07-29",{"date":339,"type":35},"2024-07-01",{"date":341,"type":22},"2026-07-01",{"name":343,"class":42},"Hospital Universitari de Bellvitge",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":17,"sex":18,"minAge":351,"maxAge":188,"enrollmentInfo":352,"targetDuration":4,"studyType":55,"phases":354,"briefSummary":356,"conditions":357,"keywords":358,"overallStatus":193,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":43},"100555630","phase-3-the-efficacy-of-topical-vaginal-oxytocin-gel-in-postmenopausal-women-with-vulvovaginal-atrophy-100555630","NCT06514586","The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy","The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vuluvovaginal Atrophy: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Postmenopausal, sexually active female subject of age 47 - 65 years, at the time of randomization, willing to provide an informed consent.\n2. Physical Assessment showing vaginal atrophy (according to the following criteria: pale, smooth, or shiny vaginal epithelium, friable, epithelium showing no rugae, loss of elasticity or turgor of the skin, dryness of labia, fusion of labia minora, vulvar lesions, or erythema.) 3. Patients with at least one present symptom (ex. vaginal dryness, itching, burning, dysuria, and\u002For dyspareunia) and able to identify one symptom as the most bothersome symptom, with at least moderate severity.\n\n4\\. Vaginal smear cytology at screening showing ≤ 5% superficial cells 5. Vaginal pH \\> 5.0 at screening 6. A level of estradiol ≤ 30 pg\u002FmL and a level of Follicle Stimulating Hormone (FSH) \\> 40 milli International Units (mIU)\u002Fml at screening 7. Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and the study follow-up visits\n\nExclusion Criteria:\n\n1. Previous treatment with other local non-hormonal moisturizers\u002Fhormonal products within 1 month or use of lubricants within 1 week prior to inclusion.\n2. Women taking systemic hormone replacement or pills within the last 6 months.\n3. Current or history of endometrial hyperplasia or uterine\u002Fendometrial, breast, or ovarian cancer, or undiagnosed vaginal bleeding\n4. Any untreated urogenital infection within 14 days prior to randomization.\n5. Ongoing treatment with systemic medications for other non-related health conditions which might impact the study results and have the potential to bring about change in the vaginal environment e.g. glucocorticosteroids, antibiotics, etc.\n6. Critically ill patients.\n7. Patients with severe renal impairment (GFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2 as measured by the Cockcroft-Gault formula).\n8. Patients with known severe hepatic impairment (Child-Pugh C; 10 - 15 points), biliary cirrhosis, or cholestasis.\n9. Patients with known or suspected allergy or any contraindications to oxytocin.","47 Years",{"count":353,"type":22},244,[355],"PHASE3","A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM.",[124,30,89],[359,360,361,362],"vulvovaginal atrophy","postmenopause","vulvovaginal","atrophy","2024-07-17",{"date":365,"type":35},"2024-07-23",{"date":367,"type":22},"2024-09",{"date":369,"type":22},"2025-08",{"name":371,"class":372},"Oxagon","NETWORK",{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":381,"targetDuration":4,"studyType":55,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":43},"100548821","phase-4-efficacy-of-the-use-of-cellular-matrix-a-cp-ha-kit-100548821","NCT06425978","Efficacy of the Use of Cellular Matrix\u002F A-CP-HA Kit","The Efficacy of the Use of Cellular Matrix \u002F A-CP-HA Kit (Combination of Autologous Platelet-rich Plasma and Non-cross-linked Hyaluronic Acid) Compared to Local Estrogen Therapy (Blissel, Estriol 50 Micrograms\u002Fg Vaginal Gel) in Women With Genitourinary Syndrome of Menopause. A Randomized Controlled Trial, With a Second Blind Observer.","CellularMatrix","Inclusion Criteria:\n\n* Women ≤70 years old\n* Women that are sexually active\n* Women who report symptoms and signs of SGM, with a vaginal health index (VHIS - Bachmann score) \\\u003C 15 points.\n* Women who understand the Spanish language\n* Willing to participate in the study and sign informed consent.\n\nExclusion Criteria:\n\n* Systemic or local hormonal treatment in the last 3 months\n* Tamoxifen or Aromatase inhibitor treatments\n* Vulvovaginal pathologies (condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, lichen sclerosus, lichen planus, history of radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation, or active genital infection (eg. g., bacterial vaginosis, genital herpes, candida) Contraindication for vaginal estrogen therapy\n* Women with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases.\n* Women who have had pelvic surgery within 6 months.\n* Women who are unwilling or unable to give informed consent and\u002For do not comply with the study requirements.",{"count":382,"type":22},192,[264],"This study is a randomized, controlled, non-inferiority trial, that will be performed on 192 women on Menopause (absence of menstruation for at least 12 months), with diagnostic of genitourinary syndrome of menopause (SGM) and a vaginal health index \\\u003C15 points, that are sexually active.\n\nPatients will be randomized 1:1, equal number assigned to each of the two treatment groups, to receive treatment with two dose of Cellular Matrix \u002F A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) separated for a month, and control group that will receive the standard treatment for SGM, local estrogen therapy (Blissel, estriol 50 micrograms\u002Fg vaginal gel).\n\nBoth groups will be follow-up for 3 and 6 month afther treatment, a blind observer will assess the application of the validated scale (VHIS, VHI), and the investigators will do the FSD, symptom record, maturation index, follow-up photography and evaluation of adverse events and treatment compliance and adherence.",[30],"2024-07-15",{"date":388,"type":35},"2024-07-16",{"date":390,"type":35},"2024-05-30",{"date":392,"type":22},"2026-08",{"name":394,"class":42},"Fundación Santiago Dexeus Font",{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":404,"conditions":405,"keywords":406,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":43},"100554739","non-ablative-diode-laser-therapy-for-genitourinary-syndrome-of-menopause-a-prospective-study-on-efficacy-safety-and-quality-of-life-and-sexuality-impact-100554739","NCT06503003","Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact","GSMLASER","Inclusion Criteria:\n\n* Post-menopausal women aged 45-73 years.\n* Sexually active.\n* Experiencing physiological amenorrhea for more than 12 months.\n* Exhibiting at least one symptom of Genitourinary Syndrome of Menopause (GSM).\n* Not using lubricants or hormonal therapy in the previous 6 months.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Untreated uterine or vulvovaginal cancers.\n* Pacemaker or other implanted electrode carriers.\n* Severe multi-organ or neurological diseases.\n* Active sexually transmitted infections.\n* Moderate to severe uterine prolapse.\n* Active urinary tract infections.\n* Acute or chronic dermatological conditions in the vulvar or vaginal area.\n* Active genital herpes.\n* Active high-risk Human Papillomavirus (HPV).\n* Ischemic tissues, unhealed wounds, sores, or undiagnosed mucosal or epithelial alterations.\n* Recent unhealed invasive or ablative surgeries.\n* Bleeding disorders or anticoagulant therapy.\n* Immunodeficiencies.\n* Uncontrolled diabetes.","73 Years",{"count":167,"type":22},"The goal of this observational study is to evaluate the efficacy, safety, and impact on quality of life and sexuality of non-ablative dual-wavelength diode laser treatments in managing Genitourinary Syndrome of Menopause (GSM) in sexually active post-menopausal women who cannot use or have not benefited from local estrogen-based therapies. The main questions it aims to answer are:\n\nDoes non-ablative dual-wavelength diode laser therapy improve vaginal dryness, burning sensation, and dyspareunia in post-menopausal women? What is the impact of this therapy on the vaginal health index and sexual function? Researchers will compare the laser-treated group to their baseline measurements to see if non-ablative dual-wavelength diode laser therapy effectively treats GSM.\n\nParticipants will:\n\nUndergo three monthly sessions of dual-wavelength diode laser therapy. Participate in follow-up evaluations at three and six months post-treatment. Complete self-assessments of GSM symptoms and questionnaires evaluating sexual function and quality of life at each follow-up.\n\nThis study aims to provide preliminary evidence that non-ablative dual-wavelength diode laser therapy is a safe and effective non-hormonal treatment for GSM, addressing a gap in existing treatments for women who cannot use or have not benefited from hormonal therapies.",[30],[30,407,124,215,95],"Diode laser","2024-07-13",{"date":388,"type":35},{"date":411,"type":35},"2023-09-01",{"date":413,"type":22},"2025-01-01",{"name":415,"class":42},"University of Cagliari",{"id":417,"slug":418,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":260,"enrollmentInfo":424,"targetDuration":4,"studyType":55,"phases":426,"briefSummary":427,"conditions":428,"keywords":429,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":439,"locationsCount":43},"100494073","use-of-fractional-co2-laser-versus-erbiumyag-laser-for-the-treatment-of-gsm-in-patients-using-aromatase-inhibitors-100494073","NCT05713435","Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors","Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of Genitourinary Syndrome of Menopause (GSM) in Patients Using Aromatase Inhibitors: Double Blinded Randomized Controlled Clinical Trial.","LASI","Inclusion Criteria:\n\nRecruited participants will meet all of these criteria:\n\n* a history of breast cancer\n* premenopausal at diagnosis of breast cancer\n* using AI as an adjuvant treatment\n* moderate to severe symptoms of GSM (VAS ≥ 4\u002F10)\n* currently menopausal, which can be either biochemical menopause as confirmed after chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of the trial)\n\nExclusion Criteria:\n\n* Not willing to abstain from vaginal intercourse for 1 week following laser therapy\n* Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion\n* Use of hormonal therapy within 6 months prior to inclusion (systemic or local)\n* Acute urinary or genital tract infections\n* A history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree laceration\n* Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System\n* Previous vaginal mesh implantation\n* Abnormal result in the last cervical smear (maximum 36 month before enrollment)\n* Active cancer treatment (radiotherapy or chemotherapy) ongoing or planned prior to the measurement of the primary outcome (6 months after inclusion, 3 months after last laser)\n* Vaginal stenosis that does not allow the placement of the laser probe\n* Any condition that could interfere with study compliance",{"count":425,"type":22},162,[57],"To study the efficacy and safety of intravaginal CO2 laser versus intravaginal Er:YAG laser and sham application in alleviating genitourinary symptoms in patients receiving an aromatase inhibitor as adjuvant treatment of breast cancer",[30],[430,431,432,433],"genitourinary syndrome of menopause","intravaginal laser","breast cancer","aromatase inhibitor","2024-06-28",{"date":339,"type":35},{"date":437,"type":35},"2022-12-27",{"date":251,"type":22},{"name":440,"class":42},"Universitaire Ziekenhuizen KU Leuven",{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":188,"enrollmentInfo":447,"targetDuration":4,"studyType":55,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":43},"100324637","radiofrequency-non-ablative-in-the-treatment-of-genitourinary-syndrome-of-menopause-100324637","NCT03506594","Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause","Inclusion Criteria:\n\n* will be women in menopause until 65 years of age with clinical complaints of Genitourinary Syndrome of Menopause and who agree to voluntarily participate in the research.\n\nExclusion Criteria:\n\n* will be excluded from the study participants with limited understanding, with neurological degenerative chronic diseases, sensory deficit in the genital region, users of pacemaker and intrauterine device of cooper and women under hormone therapy under six months",{"count":448,"type":22},58,[57],"The study is conducted in women at the menopause with a clinical diagnosis of Genitourinary Syndrome, which presents symptoms in of vulvovaginal atrophy and tract urinary and were treated with radiofrequency non ablative technique for capacitive transfer in intra-vaginal. All participants were evaluated by a physical therapist and did the exam of PH vaginal, cell maturation index and questionnaires. The participants made five sessions of Radio Frequency (RF) with an interval of seven days between them. The application of RF was performed by physical therapist trained in the technique of radio frequency through the Capenergie brand device with capacitive transfer method using non-ablative handle with active electrode intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 minutes more in the posterior wall of vagina.",[30],"2024-05-27",{"date":454,"type":35},"2024-05-29",{"date":456,"type":35},"2018-04-01",{"date":458,"type":22},"2026-06-20",{"name":460,"class":42},"Centro de Atenção ao Assoalho Pélvico"]