Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-01 @ 11:24 PM
Study NCT ID:
NCT04042766
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2019-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Vaginal Treatment for GSM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2019-07-31', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "subjective measure of change in: the patient's most bothersome symptom", 'timeFrame': 'Baseline and 3 months after treatment start', 'description': 'The most bothersome symptom of GSM (vaginal dryness, discomfort, itching, dyspareunia, urinary urgency, dysuria) will be identified and its severity rated on a standardized 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menopausal Urethral Atrophy', 'Vulvar Atrophy']}, 'descriptionModule': {'briefSummary': "Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Females aged 45-70 years;\n2. 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);\n3. at least 1 vaginal symptom reported from the following list, experienced for the past 30 days which is moderate or severe at least once a week: dryness \\| itching \\| irritation \\| soreness/pain \\| dyspareunia;\n4. no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;\n5. vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Patient is pregnant/lactating\n2. unexplained abnormal genital bleeding\n3. current acute vaginal/ bladder infection\n4. antibiotic use the past 30 days;\n5. women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary;\n6. concurrent use of any other new GSM treatment\n7. pelvic surgery \\<3 months\n8. current treatment for chronic pelvic pain'}, 'identificationModule': {'nctId': 'NCT04042766', 'briefTitle': 'Laser Vaginal Treatment for GSM', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Laser Vaginal Treatment for GSM', 'orgStudyIdInfo': {'id': '094-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'laser treatment', 'interventionNames': ['Procedure: laser vaginal treatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham treatment', 'interventionNames': ['Procedure: laser vaginal treatment']}], 'interventions': [{'name': 'laser vaginal treatment', 'type': 'PROCEDURE', 'description': 'Er:YAG laser', 'armGroupLabels': ['laser treatment', 'sham treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Razia Sultana, MD', 'role': 'CONTACT'}], 'facility': 'Sunnybrook Health Sciences Centre, University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Razia Sultana, MD', 'role': 'CONTACT', 'email': 'razia.sultana@sri.utoronto.ca', 'phone': '4164806100', 'phoneExt': '87776'}], 'overallOfficials': [{'name': 'Patricia Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}