[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054200":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":40,"centralContacts":41,"locations":47,"responsibleParty":61,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":40,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":40,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":100,"whyStopped":40,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Centro de Atenção ao Assoalho Pélvico","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"GSM - Home-Based Blue LED Photobiomodulation","EXPERIMENTAL","Participants diagnosed with Genitourinary Syndrome of Menopause (GSM) will receive blue LED photobiomodulation (401 ± 5 nm) through a home-based protocol. Treatment will be administered for 8 minutes per session, three times per week, totaling 24 sessions. Participants will receive standardized training and instructions regarding device use and treatment procedures.",[13],"Device: Blue LED Photobiomodulation",{"label":15,"type":10,"description":16,"interventionNames":17},"GSM - Outpatient Blue LED Photobiomodulation","Participants diagnosed with Genitourinary Syndrome of Menopause (GSM) will receive blue LED photobiomodulation (401 ± 5 nm) in an outpatient setting. Treatment will be administered for 8 minutes per session, three times per week, totaling 24 sessions, under supervision of trained healthcare professionals.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"BV - Home-Based Blue LED Photobiomodulation","Participants diagnosed with Bacterial Vaginosis (BV) will receive blue LED photobiomodulation (401 ± 5 nm) through a home-based protocol. Treatment will be administered for 15 minutes per session, twice weekly, totaling 8 sessions. Participants will receive standardized training for safe and appropriate device use.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"BV - Outpatient Blue LED Photobiomodulation","Participants diagnosed with Bacterial Vaginosis (BV) will receive blue LED photobiomodulation (401 ± 5 nm) in an outpatient setting. Treatment will be administered for 15 minutes per session, twice weekly, totaling 8 sessions, under supervision of trained healthcare professionals.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"VVC - Home-Based Blue LED Photobiomodulation","Participants diagnosed with Vulvovaginal Candidiasis (VVC) will receive blue LED photobiomodulation (401 ± 5 nm) through a home-based protocol. Treatment will be administered for 15 minutes per session, twice weekly, totaling 8 sessions. Participants will be trained to perform the intervention safely at home.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"VVC - Outpatient Blue LED Photobiomodulation","Participants diagnosed with Vulvovaginal Candidiasis (VVC) will receive blue LED photobiomodulation (401 ± 5 nm) in an outpatient setting. Treatment will be administered for 15 minutes per session, twice weekly, totaling 8 sessions, under supervision of trained healthcare professionals.",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DEVICE","Blue LED Photobiomodulation","Blue LED photobiomodulation (401 ± 5 nm) delivered through a vaginal light-emitting device. Participants will receive treatment according to the assigned protocol (home-based or outpatient). For participants with Genitourinary Syndrome of Menopause, treatment will consist of 8-minute sessions performed three times per week for a total of 24 sessions. For participants with Bacterial Vaginosis or Vulvovaginal Candidiasis, treatment will consist of 15-minute sessions performed twice weekly for a total of 8 sessions.",[19,23,9,15,27,31],null,[42],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"Patricia Virginia Lordelo","CONTACT","(+55 71) 99972-0687","pvslordelo@hotmail.com",[48],{"facility":49,"status":40,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":40},"Escola Bahiana de Medicina e Saúde Pública","Salvador","Estado de Bahia","40.290-000","Brazil","BR",{"type":56,"coordinates":57},"Point",[58,59],-38.49096,-12.97563,{"lat":59,"lon":58},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"SPONSOR_INVESTIGATOR","Patricia Lordelo","Associate Professor",[66],{"name":67,"class":6},"Escola Bahiana de Medicina e Saude Publica","100054200","photobiomodulation-for-vaginal-dysfunctions-home-based-vs-outpatient-treatment-100054200",false,"NCT07697768","Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment","Therapeutic Response to Photobiomodulation in Home-Based and Outpatient Protocols for Vaginal Dysfunctions: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Women aged 18 to 75 years.\n* Clinical and\u002For laboratory-confirmed diagnosis of Genitourinary Syndrome of - Menopause (GSM), Bacterial Vaginosis (BV), or Vulvovaginal Candidiasis (VVC), according to established diagnostic criteria.\n* Ability to understand study procedures and provide written informed consent.\n* Willingness to comply with study procedures and follow-up assessments.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Use of a pacemaker or other implanted electronic medical device.\n* Active gynecological malignancy or suspicion of gynecological cancer.\n* Neurological and\u002For psychiatric disorders associated with cognitive impairment that may interfere with understanding study procedures.\n* Use of antibiotics, antifungal agents, corticosteroids, or vaginal creams within the previous 30 days in participants diagnosed with BV and\u002For VVC.\n* Suspected or confirmed vulvovaginal conditions other than GSM, BV, or VVC.\n* Any condition deemed by the investigators to compromise participant safety or interfere with study participation.","FEMALE","18 Years","75 Years",{"count":79,"type":80},150,"ESTIMATED","INTERVENTIONAL",[83],"NA","Vaginal disorders, including vulvovaginal candidiasis (VVC), bacterial vaginosis (BV), and genitourinary syndrome of menopause (GSM), are highly prevalent conditions that significantly affect women's quality of life and sexual health. These disorders are associated with inflammatory changes, vaginal dysbiosis, and symptoms such as pruritus, abnormal vaginal discharge, dryness, and dyspareunia. In this context, photobiomodulation has emerged as a noninvasive therapeutic approach with anti-inflammatory and tissue-repair properties. This study is a randomized clinical trial designed to compare the therapeutic response to blue LED photobiomodulation (401 ± 5 nm) delivered through home-based and outpatient treatment protocols. A total of 150 women aged 18 to 75 years with a diagnosis of GSM, BV, or VVC will be enrolled and randomly assigned to one of two treatment groups. Clinical and laboratory assessments will be performed before and after treatment. Participants will also complete the Female Sexual Function Index (FSFI) and the 36-Item Short Form Health Survey (SF-36). Outcomes will include the evaluation of gynecological signs and symptoms, sexual function, quality of life, treatment adherence, and adverse events. The anticipated risks are minimal and primarily related to potential discomfort during gynecological examinations and possible embarrassment associated with discussing sensitive health information. The study is expected to demonstrate that photobiomodulation may improve clinical and functional outcomes, representing a safe, non-hormonal therapeutic alternative for the management of vaginal disorders.",[86,87,88],"Genitourinary Syndrome of Menopause (GSM)","Bacterial Vaginosis","Vulvovaginal Candidiasis (VVC)",[90,91,92,93,87,94,95,96,97,98,99],"Photobiomodulation","Blue LED","Vaginal Disorders","Vulvovaginal Candidiasis","Genitourinary Syndrome of Menopause","Sexual Function","Non-Hormonal Therapy","Randomized Clinical Trial","Home-Based Therapy","Outpatient Therapy","NOT_YET_RECRUITING","2026-07-09",{"date":103,"type":104},"2026-07-13","ACTUAL",{"date":106,"type":80},"2026-07-30",{"date":108,"type":80},"2028-05-20",{"name":63,"class":6},1]