[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvovaginal-signs-and-symptoms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvovaginal-signs-and-symptoms":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":38,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100590048","changes-in-the-impact-of-genitourinary-syndrome-of-menopause-with-a-novel-nonhormonal-vulvovaginal-gel-assessed-by-proms-100590048",false,"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.","FEMALE","40 Years","70 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30,31,32,33,34,35,36,37],"Vulvar Atrophy","Vulvovaginal Signs and Symptoms","Genitourinary Syndrome of Menopause","Quality of Life","Menopause Related Conditions","Dyspareunia","Urinary Incontinence, Urgency-frequency","Sexual Function","Women´s Health","Vaginal Dryness",[30,29,39,31,40,36],"Patient Reported Outcome Measures","Day-to-Day Impact of Vaginal Ageing","RECRUITING","2026-03-25",{"date":44,"type":45},"2026-03-30","ACTUAL",{"date":47,"type":45},"2024-01-08",{"date":49,"type":22},"2026-12",{"name":51,"class":52},"Mucosa Innovations, S.L.","INDUSTRY",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":19,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":53},"100565978","vulvovaginal-graft-versus-host-disease-diagnosis-and-microbiome-evaluation-100565978","NCT06649201","Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation","Inclusion Criteria:\n\n* Female participants planning to undergo allogeneic HCT for any disease indication, OR, female participants who have already received HCT and have developed vulvovaginal GVHD during their post-transplant follow-up period\n* All conditioning regimens (myeloablative or reduced intensity) will be included.\n* All donor sources (HLA matched\u002Fmismatched related, unrelated, umbilical cord, haploidentical) will be included.\n* All graft sources (bone marrow or peripheral blood stem cells) will be included.\n* All GVHD prophylaxis regimens will be included.\n* Aged 18-70.\n* English speaking and able to sign written informed consent.\n* Participants agree to a vaginal gynecologic exam.\n* Co-enrollment on other clinical trials will be allowed.\n\nExclusion Criteria:\n\n* Participants who decline or unable to undergo vaginal gynecologic exam due to any discomfort or pain.\n* Any concurrent medical, psychiatric or other illness in which the provider believes the participants may not be able to comply with study assessments.\n* Participants with a current diagnosis of a sexually transmitted infection (STI) (Herpes Simplex Virus, Gonorrhea, Chlamydia, Trichomonas,) or a history of previously untreated STI which may incite inflammation that will impact the microbiome.\n* Participants with a history of lichen sclerosis, lichen planus, pre-transplant.\n* Participants with a history or current diagnosis of vaginal or vulvar malignancy.","18 Years",{"count":62,"type":22},40,"OBSERVATIONAL","The goal of this observational study is to investigate the development of vulvovaginal graft-versus-host- disease (GVHD), an under-reported and under-recognized manifestation of chronic GVHD. This study aims to characterize the vaginal microbiome in participants undergoing allogeneic hematopoietic cell transplantation (HCT). The main questions it aims to answer are:\n\n* Is the vaginal microbiome altered during allogeneic HCT?\n* What changes may help researchers understand the development of vulvovaginal GVHD?\n\nParticipants will be asked to undergo an assessment of vulvovaginal symptoms through a vulvovaginal symptom questionnaire once pre-transplant, 6 months post-transplant, and twelve12 months post- transplant. Participants will also be asked to undergo a vaginal microbiome (collection of bacteria, fungi, and viruses that live on our bodies) evaluation through a vaginal exam performed by a gynecologist with collection of vaginal samples once pre-transplant and again six months post-treatment and twelve months post-transplant. If a participant develops symptoms of vulvovaginal GVHD at any point in time during the post-transplant follow up, the participant may partake in additional vaginal exams to diagnose GVHD at the time of symptom onset.",[66,29],"Graft Vs Host Disease",[68,69,70,71,72,73],"Allogeneic Hematopoietic Cell Transplantation","Vaginal Microbiome","GVHD","HCT","Vulvovaginal GVHD","Vulvovaginal graft-versus-host disease","2026-03-05",{"date":76,"type":45},"2026-03-09",{"date":78,"type":45},"2024-12-19",{"date":80,"type":22},"2027-02-15",{"name":82,"class":83},"Case Comprehensive Cancer Center","OTHER"]