[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvodynia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvodynia":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,39,73,121,143,171,197,229,250,274,297,318,341],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100635517","effectiveness-of-a-four-session-focal-shock-wave-therapy-protocol-in-women-with-vulvodynia-100635517",false,"NCT07553715","Effectiveness of a Four-Session Focal Shock Wave Therapy Protocol in Women With Vulvodynia","Evaluation of the Effectiveness of a Four-Session Low-Intensity Focal Extracorporeal Shock Wave Therapy (LiSWT) Protocol in Women With Vulvodynia: A Retrospective Observational Cohort Study","Shock-V","Inclusion Criteria:\n\n* Female patients aged 18 years or older\n* Clinical diagnosis of vulvodynia\n* Received at least one session of low-intensity focal extracorporeal shock wave therapy in routine clinical practice\n\nExclusion Criteria:\n\n* Refusal to participate (non-opposition not obtained)\n* Inability to understand French language, preventing completion of study questionnaires","FEMALE","18 Years",{"count":20,"type":21},50,"ESTIMATED","OBSERVATIONAL","Vulvodynia is a chronic vulvar pain condition that can significantly affect quality of life. Low-intensity focal extracorporeal shock wave therapy has been proposed as a non-invasive therapeutic option, but real-world data remain limited.\n\nThis retrospective observational study aims to evaluate the effectiveness of a four-session focal shock wave therapy protocol in women with vulvodynia treated in routine clinical practice at a university hospital. Clinical data collected during standard care, as well as questionnaire responses, will be analyzed to assess changes in symptoms and functional outcomes following treatment.",[25],"Vulvodynia","RECRUITING","2026-06-23",{"date":29,"type":30},"2026-06-24","ACTUAL",{"date":32,"type":30},"2026-04-01",{"date":34,"type":21},"2026-12-01",{"name":36,"class":37},"Nantes University Hospital","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100566825","biomodulation-and-rehabilitation-interventions-to-target-pelvic-health-100566825","NCT06660212","Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health","Is Multimodal Physiotherapy and\u002For Photobiomodulation Therapy Effective for Pain Reduction Among Those Who Experience Provoked Vestibulodynia: a Randomized Controlled Trial","BRIGHT","Inclusion Criteria:\n\n* Willing to travel to Ottawa area or Quebec City area\n* Biologically born female older than eighteen years\n* Pre-menopausal\n* Not currently pregnant or pregnancy\u002Fgiven birth in the past six months\n* Experiencing signs and symptoms consistent with provoked vestibulodynia alone or provoked vestibulodynia plus vaginismus\n\nExclusion Criteria:\n\n* gynaecologist cannot insert a single digit intravaginally and thus the participant would be unlikely able to tolerate the assessment procedures\n* other gynaecologic conditions such as lichen sclerosus, fissures, endometriosis, adenomyosis, or pelvic organ prolapse",{"count":48,"type":21},240,"INTERVENTIONAL",[51],"NA","This trial will provide evidence for the effective management of pain and pain-related domains among those who experience provoked vestibulodynia (PVD) using photobiomodulation (PBM) and multimodal physiotherapy (mPT) in a randomized controlled trial (RCT). PVD is the most common subcategory of vulvovaginal pain experienced during sexual and non-sexual activities, affects the psychological and sexual health of an astounding one in five Canadian women, yet access to evidence-informed management approaches is limited. We will employ four intervention groups: PBM, sham PBM (control), PBM combined with mPT, and mPT with sham PBM to evaluate the effectiveness of each approach on its own and the two approaches in combination.\n\nAmong those who experience PVD, we seek to answer:\n\n1. Relative to baseline and to sham PBM, does a 14-week intervention involving PBM, mPT, or a combination of mPT and PMB reduce vulvar pain severity reported on the Vulvar Pain Assessment Questionnaire (VPAQ)?\n2. Is a combined mPT and PBM intervention more effective than mPT or PMB alone when considering vulvar pain severity and\u002For related domains as measured through VPAQ?\n3. Are positive changes in vulvar pain severity and related domains observed following a 14-week intervention involving PBM, mPT or a combination of PBM and mPT retained at 6 months and at 1 year?\n\nSecondary objectives include determining the effectiveness of PBM, mPT, and mPT combined with PBM relative to sham PBM on: Patient Global Impression of Change (PGIC), pain sensitivity measured using provocative tests, the other domains of the VPAQ, sexual function, as well as investigating mediating effects of psychosocial variables (central sensitization index, chronic pain acceptance), gender identity, and the presence of vaginismus on patient response to mPT, PBM and mPT combined with PBM. Lastly we will monitor patient satisfaction with the interventions, adherence to the interventions, and any adverse events.",[25,54,55],"Provoked Vestibulodynia","Dyspareunia",[57,58,25,59,60,61,62],"Provoked vestibulodynia","Intervention","Double-blinded","Pelvic floor","laser","Vulvar pain","2026-04-28",{"date":65,"type":30},"2026-05-05",{"date":67,"type":30},"2025-03-17",{"date":69,"type":21},"2028-11",{"name":71,"class":37},"University of Ottawa",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":49,"phases":82,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100612703","phase-2-topical-ketotifen-025-for-secondary-vestibulodynia-100612703","NCT07257029","Topical Ketotifen 0.25% for Secondary Vestibulodynia","A Multi-center, Randomized, Double-blind, Placebo-controlled Trial of Topical Ketotifen Fumarate 0.25% Cream for Females With Secondary Vestibulodynia","Inclusion Criteria:\n\n* Female participants ≥18 years of age\n* Able to provide signed and dated informed consent\n* Able to read, write, understand, and complete English-language study-related forms and communicate in English\n* Has a stable address and is available for the duration of the study\n* In good general health based on medical history\n* Willing to comply with all study procedures\n* Body mass index (BMI) between 18.5 kg\u002Fm² and 32.0 kg\u002Fm² (inclusive)\n* Meets ISSVD\u002FISSWSH\u002FIPPS criteria for secondary provoked vestibulodynia, including: 6 continuous months of vulvar symptoms (insertional dyspareunia, pain with tampon insertion, or pain to touch); moderate to severe vestibular tenderness to light touch on physical exam\n* No evidence of vulvovaginal atrophy\n* If atrophy is present, must complete ≥12 weeks of topical hormone therapy and be re-screened to confirm resolution before enrollment\n* Negative vaginal culture for infection at randomization (participants with positive cultures at screening may be treated and retested)\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Unable to tolerate the smallest dilator during baseline dilator assessment\n* Active vaginal infection (Candida, BV, trichomonas, HSV)\n* May re-screen after treatment and documented cure\n* Active cutaneous disease of the vestibule\n* Current presentation of other painful vulvar conditions, including:\n\nPudendal neuralgia Lichen sclerosus Lichen planus Plasma cell vulvitis Vulvar intraepithelial neoplasia Sjögren's disease Desquamative inflammatory vaginitis\n\n* Hypoestrogenic states (e.g., vulvar atrophy due to menopause or medications)\n* History of significant vestibular or vaginal surgery, including:\n\nVestibulectomy Perineoplasty Bladder neck suspension Anterior\u002Fposterior colporrhaphy Pudendal nerve neurolysis Ablative or fractional laser procedures\n\n* Initiation or planned change in any of the following within 30 days before screening or during the study:\n\nGabapentinoids Tricyclic antidepressants SSRIs or SNRIs Hormone replacement therapy Systemic or local muscle relaxants (benzodiazepines, baclofen, botulinum toxin, cyclobenzaprine, CBD suppositories) Pelvic floor physical therapy\n\n* Use of another investigational drug or intervention within the past 3 months\n* Positive vaginal culture during the study requiring two or more treatments (per protocol, second infection leads to termination)\n* Any condition or factor that, in the opinion of the investigator, would interfere with study participation or safety",{"count":81,"type":21},54,[83],"PHASE2","This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of topical ketotifen fumarate 0.25% cream in adult women with secondary provoked vestibulodynia (PVD). Secondary PVD is a chronic vulvar pain condition characterized by burning or sharp pain with vaginal penetration (e.g., intercourse, tampon use) and touch of the vulvar vestibule, often following recurrent infections or topical irritant exposures. Preclinical studies suggest that ketotifen, a mast-cell stabilizer and histamine H1 antagonist, may reduce neuroinflammation and abnormal nerve growth in the vulvar vestibule, offering a mechanism-based, non-surgical treatment option.\n\nApproximately 54 women aged 18 years and older who meet ISSVD\u002FISSWSH\u002FIPPS criteria for secondary PVD without vulvovaginal atrophy will be enrolled. After a 1-week screening period, all participants will complete a 2-week single-blind placebo run-in; those with a strong placebo response or intolerance to vehicle cream will not be randomized. Eligible participants will then be randomized 1:1 to receive ketotifen fumarate 0.25% cream or matching placebo cream applied twice daily to the vulvar vestibule for 12 weeks.\n\nThe primary outcome is change from baseline to Week 15 in pain intensity with the baseline dilator maximum tested size (DMTS), measured on an 11-point numeric rating scale. Secondary outcomes include changes in Vulvodynia Experience Questionnaire (VEQ) scores, vestibular pain thresholds measured by Wagner algometry, and participant-reported meaningful benefit at the end of treatment. Safety assessments will include adverse events, application-site reactions, physical examinations, vital signs, and pregnancy testing. This study will provide the first controlled clinical data on topical ketotifen for secondary PVD and inform the feasibility of larger registration trials.",[54,86,25,87,88,89,90],"Secondary Provoked Vestibulodynia","Vulvary Pain Disorders","Neuroproliferative Vestibulodynia","Mast Cell-mediated Neuroinflammation","Instertional Dyspareunia",[92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110],"ketotifen fumarate","vulvodynia","provoked vestibulodynia","secondary vestibulodynia","vulvar pain","insertional dyspareunia","mast cell stabilizer","neuroproliferative pain","topical antihistamine","vulvar vestibule","non-hormonal treatment","vestibular tenderness","female sexual pain","vestibulodynia clinical trial","vulvar pain disorder","randomized controlled trial","algometer","dilator test","vulvodynia experience questionnaire (VEQ)","2026-03-16",{"date":113,"type":30},"2026-03-18",{"date":115,"type":30},"2026-01-02",{"date":117,"type":21},"2027-01-01",{"name":119,"class":37},"Center for Vulvovaginal Disorders",3,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":49,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":140,"locationsCount":38},"100623023","phase-2-a-phase-2-study-to-evaluate-the-efficacy-and-safety-of-pudafensine-in-vulvodynia-provoked-vestibulodynia-100623023","NCT07391241","A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)","A Randomised, Double-blind, Placebo-controlled, 4-way Cross-over Trial Studying the Efficacy and Safety of Single Dose Administration of Pudafensine in Vulvodynia (Provoked Vestibulodynia).","Inclusion Criteria:\n\n* Participant with vulvodynia (provoked vestibulodynia).\n\nExclusion Criteria:\n\n* Women with vulvar pain caused by a specific disorder:\n\n  1. Infectious (e.g. recurrent candidiasis, herpes).\n  2. Inflammatory (e.g. lichen sclerosus, lichen planus, immunobullous disorders).\n  3. Neoplastic (e.g. Paget disease, squamous cell carcinoma).\n  4. Neurologic (e.g. postherpetic neuralgia, nerve compression or injury, neuroma).\n  5. Trauma (e.g. female genital cutting, obstetrical).\n  6. Iatrogenic (e.g. postoperative, chemotherapy, radiation).\n  7. Hormonal deficiencies (e.g. genitourinary syndrome of menopause (vulvovaginal atrophy), lactational amenorrhea).\n* History or current diagnosis of significant pelvic floor dysfunction.\n* Co-morbid pelvic pain conditions including pain due to pelvic fractures, pelvic girdle pain or post-partum pelvic pain (to avoid confounding pain outcomes).\n* History or current diagnosis of pelvic inflammatory disease.\n* History or current diagnosis of endometriosis.\n* History or current diagnosis of interstitial cystitis.","65 Years",{"count":130,"type":21},24,[83],"The study (IP2015CS05) is a randomised, double-blind, placebo-controlled, 4-way cross-over trial studying the efficacy and safety of single dose administration of pudafensine in vulvodynia (provoked vestibulodynia) patients.",[25],"2026-01-29",{"date":136,"type":30},"2026-02-05",{"date":138,"type":30},"2025-12-17",{"date":34,"type":21},{"name":141,"class":142},"Initiator Pharma","INDUSTRY",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":151,"sex":17,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":156,"studyType":22,"phases":4,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":38},"100196134","prospective-data-bank-creation-to-study-vaginal-conditions-100196134","NCT01829204","Prospective Data Bank Creation to Study Vaginal Conditions","A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach","CRIPB-13-002","Inclusion Criteria:\n\n* All patients willing to participate, and give informed consent, and\n* Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination.\n* Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition.\n* Pregnant women ages 21 to 75 years who are both asymptomatic and healthy\n* Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition\n\nExclusion Criteria:\n\n* Asymptomatic patients ages \\\u003C 21 or \\> 75, or symptomatic patients ages \\\u003C 21 or \\> 75 years.\n* Patients diagnosed with cancer or having any medical condition that is not under control including: diabetes mellitus, hypertension, collagen disease, hemoglobinopathy, renal insufficiency, depression, anxiety, psychosis and panic attacks\n* Patients unable to follow the protocol or unwilling to participate",true,"21 Years","75 Years",{"count":155,"type":21},550,"12 Months","The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.",[25,159,160,161],"Mycoses","Bacterial Vaginosis","Preterm Labor","2025-12-10",{"date":164,"type":30},"2025-12-18",{"date":166,"type":4},"2013-04",{"date":168,"type":21},"2027-12",{"name":170,"class":37},"Texas Tech University Health Sciences Center",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":49,"phases":179,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":72},"100612995","phase-2-use-of-topical-testosterone-and-estrogen-vs-estrogen-alone-in-vulvodynia-a-randomized-controlled-trial-100612995","NCT07260825","Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial","Inclusion Criteria:\n\n* 18 years or older\n* Patients with vulvodynia who present with pain (with vaginal penetration) rating score of 4 or greater\n\nExclusion Criteria:\n\n* Active vaginal infection\n* Pregnancy\n* Breast-feeding\n* Taking anti-androgenic medication (finasteride, dutasteride)\n* Using any other topical hormones to the vulva or vagina",{"count":178,"type":21},44,[83,180],"PHASE3","We are looking to see if patients using both topical testosterone and estrogen will have a greater improvement in pain with vaginal penetration compared to those using topical estrogen alone.",[25,55,183],"Lichen Sclerosus of Vulva",[185,186,93],"topical testosterone","estrogen cream","NOT_YET_RECRUITING","2025-11-21",{"date":190,"type":30},"2025-12-03",{"date":192,"type":21},"2025-12",{"date":194,"type":21},"2026-08",{"name":196,"class":37},"TriHealth Inc.",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":205,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":49,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":38},"100600041","young-vulvodynia-effect-and-efficacy-of-multimodal-treatment-100600041","NCT07092332","Young Vulvodynia: Effect and Efficacy of Multimodal Treatment.","Young Vulvodynia: Effect and Efficacy of a Multimodal Treatment for Young Women With Vulvar Pain","UV","Inclusion Criteria:\n\n* Biological sex female\n* 15-23 years of age\n* Diagnosed with Provoked vulvodynia\n\nExclusion Criteria:\n\n* Severe psychological issues that should be prioritized before vulvodynia treatment (e.g., substance abuse, psychosis)\n* Ongoing pregnancy\n* Childbirth within the last year\n* Post-traumatic stress disorder (PTSD) related to sexual trauma\n* Insufficient mastery of the Swedish language\n* No experience of vaginal sex, as vaginismus might be suspected, which requires different treatment","15 Years","23 Years",{"count":208,"type":21},15,[51],"The aim of this SCED-study is to evaluate a multimodal treatment for vulvodynia in young women. The main questions it aims to answer are:\n\nIs multimodal treatment effective for provoked vulvodynia in young women? How is multimodal treatment experienced by young women with vulvodynia?\n\nParticipants will respond to frequent questionnaires (two times a week) during a baseline period of 4,5 or 6 weeks, as well as during their treatment period ( a total of 25 weeks). In addition they will respond to pre-, post-treatment and 6 month follow-up questionnaires.",[25],[25,213,214,215,216,217,218,219],"Provoked Vulvodynia","Multimodal Treatment","Cognitive Behavior Therapy","Single-Case Experimental Design","Chronic Pain","Adolescent","Emerging Adulthood","2025-07-22",{"date":222,"type":30},"2025-07-29",{"date":224,"type":30},"2025-06-10",{"date":226,"type":21},"2026-12-31",{"name":228,"class":37},"Region Örebro County",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":151,"sex":17,"minAge":18,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":38},"100582642","vestibulodynia-at-high-resolution-omics-approach-to-improve-diagnosis-100582642","NCT06865963","Vestibulodynia At High Resolution: Omics Approach to Improve Diagnosis","Inclusion Criteria:\n\n* Age between 18 and 50\n* abstinence from intercourse for 7 days prior to the visit\n* non-use of intravaginal products for 7 days prior to the visit\n\nExclusion Criteria:\n\n* patients whit generalized vulvodynia and those with only spontaneous, but not provoked vestibulodynia\n* Endometriosis\n* Pregnancy\n* Infectious vulvar disease\n* Post-menopause\n* Feeding time\n* gave birth within 4 months\n* received systemic or vaginal antimicrobial or probiotic therapy within 1 month before the visit","50 Years",{"count":237,"type":21},400,"According to recent nomenclature, vulvodynia is vulvar pain without a clear identifiable cause persisting for at least 3-months and distinguished from vulvar pain caused by a specific disorder (inflammatory, neoplastic, traumatic). Vulvodynia can be provoked (when the pain is felt after touching the area), or unprovoked (pain is constant). Localized provoked vulvodynia of the vestibule, known as vestibulodynia (VBD), is the most common manifestation of the disease (about 80%). Data collected suggests that up to 16% of women, particularly sexually active reproductive-aged women, suffers from this condition. Despite affecting almost 1 out of 8 women of all ages, vulvodynia remains completely unacknowledged to the most. These data highlight that VBD cannot be considered a rare disease, but it rather is a high frequency women's health condition, albeit neglected and hard to diagnose because of a lack of obvious markers. Despite the paucity of molecular data, studies about pathogenesis of VBD have highlighted several risk factors including inflammation, recurrent vulvovaginal infections and microbiota dysfunction, mucosal nerve fiber proliferation, hormonal alterations, pelvic floor muscle dysfunction, central pain mechanisms, and genetic factors. A recent study has highlighted that, compared to healthy controls, women with VBD demonstrated differences primarily in vaginal (but not plasma) concentrations of metabolites of the sphingolipid signaling pathways, suggesting localized effects in vagina and vulvar vestibule rather than systemic effects. The current prevalent theory on the etiology of VBD is that during or after an initial and persistent vulvovaginal insult (infection, microtrauma, allergic reaction), a \"susceptible\" individual is then unable to successfully clear the inflammation process that alters and sensitizes the neural tissue in the vestibular area, resulting in localized allodynia and hyperalgesia. The under-diagnosis of VBD is the result of different factors including practical, cultural, sociological and psychological ones. The women with VBD confirmed that healthcare provider knowledge and attitudes as well as system challenges (specialist and allied healthcare provider availability) are major barriers to timely diagnosis, mainly due to lack of diagnostic tests. For instance, many patients do not seek treatment due to feelings of inadequacy, invalidation, isolation or guilt. This attitude also has a cultural background that is rooted in shame, in the endurance of pain, in embarrassment and resulting silence of patients, dismissal of vulvar pain as a \"psychological disorder\" by clinicians have resulted in widespread ignorance about this disabling condition. Finally, one of the most important, and doubtlessly the easiest one to solve, is the lack of either molecular or cellular markers of the disease itself. Unfortunately the VBD diagnosis always comes too late, when the mechanism of aberrant immune response already has caused the irreversible nervous sprouting in the vulvar vestibule and the chronicization of the symptoms has already happened. This delayed diagnosis increases the women's risk for sexual dysfunction and diminishes their quality of life. The VBD diagnosis is generally a diagnosis of exclusion, where basically all other possible differential diagnoses have been excluded and this is what is \"left over\". Many markers of inflammation were investigated without significant results, likely because the method employed in the study was focused on few pre-selected targets and an unbiased analysis has not been performed, yet. For all these reasons, the search for suitable diagnostic markers of VBD remains a high but unmet research priority. In the NGS era the absence of genomic study of VBD is despicable. RNA-sequencing of vestibule vaginae (vestibular) cell swab is a pain-free method that we already tested and could allow the identification of diagnostic markers of VBD for the development and the optimization of a reliable and quantifiable diagnostic test. In this context we plan to perform transcriptomic analysis integrated with the state-of-the-art single cell omic analysis on VBD patients and healthy controls to unbiasedly identify specific VBD markers. Moreover, considering the different pathogenesis and the range of symptoms and severity of the disease, with these markers we also aim at stratifying different groups of VBD. This stratification will lay the foundation for further studies to move patients towards a real personalized medicine. This analysis has never been performed on VBD patients with this global approach and at such high resolution. The results of our project will help the clinicians in VBD diagnosis, in therapy direction and in the earlier identification of patients with higher risk to develop chronic VBD, thus helping to build a preventive strategy to avoid the progression and chronicization of the symptoms",[240,25],"Vestibulodynia (VBD)","2025-03-06",{"date":243,"type":30},"2025-03-10",{"date":245,"type":30},"2024-06-25",{"date":247,"type":21},"2026-06-25",{"name":249,"class":37},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":49,"phases":260,"briefSummary":261,"conditions":262,"keywords":263,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":38},"100417106","lasertherapy-for-vulvodynia-100417106","NCT04711369","Lasertherapy for Vulvodynia","Lydia","Inclusion Criteria:\n\n* Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)\n* multidisciplinary treatment for at least 3 months\n* Informed consent\n\nExclusion Criteria:\n\n* Current genital infection (i.e. candidiasis, herpes )\n* Inflammatory vulvar disease\u002F dermatosis (i.e. lichen sclerosus, lichen planus)\n* Neoplastic vulvar disease (e.g. HSIL Vulva, Paget disease)\n* Recent vulvar trauma (i.e. bleeding, erosion or ulceration)\n* Pudendal neuralgia\n* Pregnancy, delivery \\\u003C6 months\n* Epilepsy or major neurologic or psychiatric morbidity\n* Active systemic infection\n* Previous treatment with ionizing radiation in the area to be treated\n* History of wound healing disorders (i.e. hyperpigmentation, abnormal scarring)\n* Fever\n* Systemic or local autoimmune disorders\n* History of photosensitivity disorder","80 Years",{"count":259,"type":21},92,[51],"The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.",[25],[264],"Erbium:Yag laser","2025-03-03",{"date":267,"type":30},"2025-03-04",{"date":269,"type":30},"2021-01-15",{"date":271,"type":21},"2026-07-30",{"name":273,"class":37},"Medical University of Graz",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":257,"enrollmentInfo":281,"targetDuration":4,"studyType":49,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":38},"100464175","acupuncture-in-a-multidisciplinary-approach-for-vulvodynia-and-chronic-pelvic-pain-100464175","NCT05324280","Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain","AMALIA","Inclusion Criteria:\n\n* Women with vulvodynia and\u002For chronic pelvic pain of at least 6 months duration\n* multidisciplinary treatment for at least 3 months\n\nExclusion Criteria:\n\n* Pregnancy\n* Current malignancy\n* Major neurologic or psychiatric morbidity\n* Study participation in Lydia trial (Lasertherapy for vulvodynia)",{"count":282,"type":21},68,[51],"Background: Vulvodynia and chronic pelvic pain (CPP) are common and challenging gynecologic pain syndromes. A multidisciplinary approach is recommended.\n\nStudy aim: To study the effectiveness of acupuncture as part of a multimodal treatment for women with vulvodynia and CPP.\n\nDesign: Randomised controlled clinical study\n\nStudy Population: Recruitment from a University outpatient clinic Study groups: Participants will be randomised (1:1)\n\n* Acupuncture group\n* Waiting list control group\n\nSample size: 68 patients\n\nStudy outcome\n\n* Subjective Pain Perception (VAS)\n* Health-related quality of life (questionnaires)",[25,286],"Chronic Pelvic Pain",[288],"acupuncture","2024-12-09",{"date":291,"type":30},"2024-12-12",{"date":293,"type":30},"2022-06-23",{"date":295,"type":21},"2026-07",{"name":273,"class":37},{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":257,"enrollmentInfo":304,"targetDuration":4,"studyType":49,"phases":306,"briefSummary":301,"conditions":307,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":38},"100465627","vestibulectomy-surgical-techniques-comparison-study-100465627","NCT05343182","Vestibulectomy Surgical Techniques Comparison Study","Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the Treatment of Provoked Localized Vulvodynia (PVD)","Inclusion Criteria:\n\n1. Reported provoked tenderness to the vestibule for at least 3 months in non-pregnant, estrogen-replete healthy subjects aged 18 years or over meeting Friedrich's criteria for PVD44-45 and supported by the ISSVD Terminology Consensus Definition45 for vulvar pain. Subjects who are \\>45years of age must have either have a maturation index52 of \\\u003C 10% parabasal cells or willingness to participate in local estrogen replacement until achieving this same clinical result.\n2. Cotton swab Test30-31 mean verbal rating score of ≥4\u002F10 in 4 of 6 defined points of the vestibule (2, 4, 6, 8, 10, 12 o'clock) and cotton swab test verbal score ≤ 2\u002F10 for the labia majora and minora, intra labial sulcus, and perineum\n3. Ability to insert a regular Tampax® tampon\n4. Baseline Tampon Test verbal pain score ≥430\n\nf. Phone and internet access e. Willingness to engage in pelvic floor physical therapy (PT)\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus)\n3. Unable or unwilling to complete baseline assessments\n4. Prior vestibulectomy or hymen surgery\n5. Prior or current use of testosterone dosed for gender affirmation",{"count":305,"type":21},118,[51],[308,25],"Vulvar Pain","2024-09-06",{"date":311,"type":30},"2024-09-19",{"date":313,"type":30},"2022-10-06",{"date":315,"type":21},"2027-06",{"name":317,"class":37},"Oregon Health and Science University",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":128,"enrollmentInfo":325,"targetDuration":4,"studyType":49,"phases":327,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":38},"100542021","light-emitting-diode-in-the-treatment-of-vulvodynia-100542021","NCT06337448","Light Emitting Diode in the Treatment of Vulvodynia","Light Emitting Diode in the Treatment of Vulvodynia: a Pilot Study","Inclusion Criteria:\n\n* vulvodynia diagnosis\n\nExclusion Criteria:\n\n* patients diagnosed with vaginal infection\n* difficulty in understanding the proposed instruments\n* patients with chronic degenerative neurological diseases\n* pregnant women",{"count":326,"type":21},10,[51],"Vulvar pain can be related to a specific cause (inflammation, cancer, trauma, infection) or can be classified as vulvodynia, when vulvar pain is idiopathic and lasts for at least three months. The main symptoms reported are pain, burning, erythema, increased sensitivity, itching and burning, which affect the quality of life, psycho-emotional well-being, relationships and sexual function of these women. Photobiomodulation has been described in the literature as an alternative to treat pain. Our group has studied blue LED for some vulvovaginal dysfunctions and, due to the positive sensory effects observed in patients with vaginal stenosis and genitourinary syndrome of menopause, it is hypothesized that this technique could also bring beneficial effects for women with vulvodynia. A pilot study will be carried out, with descriptive data, with 10 women with vulvodynia. Participants will be evaluated with a basic anamnestic questionnaire and sociodemographic data. The following questionnaires will be used: Female Sexual Function Index (FSFI), Sexual Quotient - Female Version, Vulvar Pain Assessment Questionnaire. After answering the questionnaires, the volunteer will undergo a perineal physical assessment by an experienced physiotherapist, which includes a) inspection of the genital region, reflex tests, assessment of the functions of the pelvic floor muscles, b) the cotton swab test to evaluate painful sensitivity in the vestibule, c) the tampon test to evaluate painful sensitivity in the introitus and vaginal canal. Pain assessments will be quantified by the visual analogue pain scale (VAS), which ranges from 0 (no pain) to 10 (maximum pain). At the end of the treatment, the participant will answer the questionnaires again, undergo reassessment of pain sensitivity in vulva, introitus and vaginal canal, of the function of the pelvic floor muscles and will be asked \"What is your perception of improvement\" and \"What is your level of satisfaction with the treatment?\". The answers will be giving according to a Likert Scale of five points. The LED application protocol will be carried out with external use equipment model Antares, from the company IBRAMED (Amparo, São Paulo, Brazil), with a cluster G2 applicator. The power will be 450mW\u002Fcm2 and dose 5J\u002Fcm2 for 2 minutes and 13 seconds (automatic programming) in 450nm waves (blue wavelength). The treatment consists of eight sessions, carried out daily, except on weekends.",[25],[93,331],"Light-emitting diode","2024-08-19",{"date":334,"type":30},"2024-08-21",{"date":336,"type":21},"2025-08-16",{"date":338,"type":21},"2026-12",{"name":340,"class":37},"Centro de Atenção ao Assoalho Pélvico",{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":235,"enrollmentInfo":348,"targetDuration":4,"studyType":49,"phases":350,"briefSummary":351,"conditions":352,"keywords":355,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":364,"locationsCount":38},"100512658","phase-2-effectiveness-of-low-dose-naltrexone-in-patients-with-different-types-of-vulvodynia-100512658","NCT05955313","Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia","Effectiveness of Low-doses of Naltrexone (LDN) on Pain Perception and Quality of Life in Women With Vulvodynia","Inclusion Criteria:\n\n1. Women from the age of 18 to the menopause or to the age of 50 (on the day of inclusion for testing).\n2. Patients who are not pregnant and do not plan to become pregnant in the next 9 months from the inclusion in the study\n3. Signing the patient's informed and voluntary consent to participate in the study.\n4. General health of the patient (WHO = 0-2).\n5. Diagnosis of vulvodynia.\n6. Negative drug test found at the visit randomization.\n7. Documented correct cytology result from 3 years ago (before the visit screening).\n8. Stable dose of drugs acting on the central nervous system used min. 1 month before the screening visit and during the entire patient's participation in the study.\n9. Acceptance or readiness to use a highly effective method of contraception from the screening visit throughout the study. Sexual abstinence is not accepted.\n10. The ability to understand the principles of testing and operating electronic devices.\n\nExclusion Criteria:\n\n1. Severe, hepatic and renal dysfunction defined as:\n\n   i. An ASPT or ALT result 5 times the upper limit; ii. The level of bilirubin 3 times above the upper limit of normal - excluding patients with Gilbert's syndrome; iii. EGFR result below 30 ml \u002F min \u002F m2, on the basis of historical studies not older than 3 years before the screening visit or from the tests performed during the screening visit according with point 12 of the Protocol, version 1.0 of March 28, 2022.\n2. Abuse of alcohol (more than 14 units per week) and other stimulants. 3. Taking psychoactive substances, including drugs, except for SSRI, SNRI, SARI (Trazodone), and anticonvulsants (Gabapentin, Pregabalin, Lamotrigine) in fixed doses from the screening visit.\n\n4\\. Taking opioid drugs in the last 2 months before the screening visit (also in OTC preparations, eg Loperamide).\n\n5\\. Taking naltrexone hydrochloride and Mysimba for weight loss at any time in your life.\n\n6\\. BTA injection in the vulva in the last 4 months before the screening visit. 7. Endovascular procedures in the area of the small pelvis in the last 6 months before the screening visit.\n\n8\\. Previous surgical procedures requiring general anesthesia (with general anesthesia) in the last 2 months before the screening visit.\n\n9\\. Completed multidisciplinary therapeutic program in the treatment of vulvodynia in the last 4 months before the screening visit.\n\n10\\. Diseases of the vulva: lichen, current contact vulvovaginitis, bacterial and \u002F or yeast infections, other dermatological diseases, recurrent genital herpes (HSV; min 4 times \u002F year).\n\n11\\. Diagnosis of current or past serious mental disorders according to the criteria of ICD-10 and DSM-5, including psychotic and organic disorders (except depression and anxiety disorders).\n\n12\\. Gynecological abnormalities requiring medical treatment: current HSIL, CIN II \u002F III, pelvic inflammation, mixed or solid ovarian tumors, simple ovarian cysts greater than 5 cm, abnormal vaginal inter-cycle bleeding.\n\n13\\. Pelvic venous diseases (PeVD), 4 criteria met on USG. 14. Pregnancy and lactation. 15. Spastic diseases: multiple sclerosis (MS), connective tissue diseases (Marfan syndrome and marfan-like syndromes), reactive arthritis (RA). 16. Vaginismus, Lamont scale 3-5 (gynecological examination impossible due to anxiety).\n\n17\\. Significant and \u002F or uncorrected disability in the field of sight or hearing, making it difficult to perform psychological tests.",{"count":349,"type":21},300,[83],"Vulvodynia (Vd) is chronic functional vulvar pain, with prevalence of 3-16% and unclear etiopathology. Although Vd significantly deteriorates quality of life, the problem is marginalized, no pharmacologic treatment standards exist. Naltrexone hydrochloride is a specific opioid antagonist with slight agonist activity. There is growing body of evidence supporting the effectiveness of low-dose naltrexone (LDN) in different types of chronic pain. The main goal of this trial is to test the effect of LDN on pain perception and quality of life in women with different types of Vd. Half of the study population receives LDN and the remaining patients take placebo, according to randomization list. This RTC is quadruplet blinded.",[25,353,354],"Naltrexone","Quality of Life",[93,356,357],"low dose naltrexone","quality of life","2023-07-12",{"date":360,"type":30},"2023-07-21",{"date":362,"type":30},"2023-05-31",{"date":226,"type":21},{"name":365,"class":37},"Medical University of Lublin"]