Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT07152704
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clitoral Sensitivity Enhancement With Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009948', 'term': 'Orgasm'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of bothersome symptoms (decreased intensity of clitoral/vaginal response, decreased time of good sexual response, decreased orgasm sensation)', 'timeFrame': 'Change from Baseline at 2 months after last intervention', 'description': 'Evaluation of clitoral sensitivity change was performed 2 months after the last treatment session. Patients answered a five-point Likert scale (from 0 to 4) questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction with 5-point Likert scale', 'timeFrame': 'Each visit included recording of any adverse effect. Patients were instructed to report and adverse effect that may have occured during the whole duration of the study.', 'description': 'Patients were asked to assess their global satisfaction with the treatment on a 5-point Likert scale (1-Very unsatisfied, 2-Unsatisfied, 3-Neutral, 4-Satisfied, 5-Very satisfied).'}, {'measure': 'Recording of frequency and severity of adverse effects related to laser treatment', 'timeFrame': 'From Baseline to 2 months after last intervention', 'description': 'Each visit included recording of any adverse effect. Patients were instructed to report and adverse effect that may have occured during the whole duration of the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-ablative', 'Er:YAG laser', 'clitoral atrophy', 'hyperstacking', 'sexual health', 'orgasm', 'clitoris'], 'conditions': ['Decreased Clitoral Sensitivity']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to evaluate whether non-ablative Er:YAG laser treatment can improve decreased clitoral sensitivity in adult women who report this concern. Effectiveness and safety will be assessed after each laser session and again at a 2-month follow-up visit.', 'detailedDescription': 'This study is designed to investigate whether non-ablative Er:YAG laser treatment can improve clitoral sensitivity in adult women who report decreased sensitivity. Reduced clitoral sensitivity can negatively impact sexual response, orgasm, and quality of life, yet effective treatment options are limited.\n\nThe primary goal of this clinical trial is to determine the effectiveness and safety of non-ablative Er:YAG laser treatment for women experiencing decreased clitoral sensitivity. Specifically, the study aims to assess:\n\nThe degree to which laser treatment enhances vaginal and clitoral sexual response, the time required to achieve noticeable improvements in sexual response, the impact of treatment on orgasmic function and patient satisfaction with the treatment process and outcomes.\n\nParticipants will undergo three laser treatment sessions, with evaluations conducted at a 2-month follow-up. Both effectiveness (improvements in sexual response and satisfaction) and safety outcomes will be carefully monitored.\n\nBy exploring this minimally-invasive therapeutic option, the study seeks to provide new insights into the management of decreased clitoral sensitivity and to help identify safe and effective approaches for improving sexual health in women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* above 18 years\n* sexually active at least once per month\n\nExclusion Criteria:\n\n* anorgasmia\n* pregnancy\n* urinary tract infections\n* genital infectious diseases of other etiology (HPV, molluscum contagiosum, syphilis, HIV, etc.)\n* genital bleeding\n* collagenopathies\n* ongoing chemotherapy\n* active genital cancer\n* patients undergoing pelvic radiotherapy\n* any genital or extragenital pathology that may interfere with treatment\n* patients who have limitations in performing a follow-up to this study\n* patients with psychiatric disorders that may be difficult to treat\n* patients who have a contraindication to vaginal laser treatments'}, 'identificationModule': {'nctId': 'NCT07152704', 'briefTitle': 'Clitoral Sensitivity Enhancement With Laser', 'organization': {'class': 'OTHER', 'fullName': 'Espacio Gaspar Clinic'}, 'officialTitle': 'Clitoral Sensitivity Enhancement With Hyperstacking of Er:YAG SMOOTH Mode', 'orgStudyIdInfo': {'id': 'CLIT / 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active therapy with non-ablative Er:YAG laser', 'description': 'Patients underwent three laser sessions with non-ablative SMOOTH Er:YAG laser, with 20 days interval between sessions', 'interventionNames': ['Device: Active therapy with non-ablative Er:YAG laser']}], 'interventions': [{'name': 'Active therapy with non-ablative Er:YAG laser', 'type': 'DEVICE', 'description': 'three intravaginal and vulvar/clitoral treatments within 60 days', 'armGroupLabels': ['Active therapy with non-ablative Er:YAG laser']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Uroclinica', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}], 'overallOfficials': [{'name': 'Adrian Gaspar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Espacio Gaspar Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Espacio Gaspar Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adrian Gaspar', 'investigatorAffiliation': 'Espacio Gaspar Clinic'}}}}