Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-05 @ 10:33 PM
Study NCT ID:
NCT06516757
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal Health and Balance', 'timeFrame': 'Baseline, Day 3, Day 7, and Day 8', 'description': 'Evaluation of vaginal health and balance via participant questionnaires.'}, {'measure': 'Vaginal Health and Balance', 'timeFrame': 'Baseline, and Day 8', 'description': 'Vaginal pH testing'}], 'secondaryOutcomes': [{'measure': 'Participant Perception of Product Convenience', 'timeFrame': 'Day 3 and Day 7', 'description': 'Assessment of participant perception of the convenience of the boric acid suppository compared to other boric acid suppositories via questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaginal pH Balance', 'Vaginal Flora', "Women's Health"], 'conditions': ['Vaginal Health', 'Bacterial Vaginosis']}, 'descriptionModule': {'briefSummary': 'This is a virtual single-group clinical trial that will last 12 weeks. Participants will use The Killer® (Boric Acid Suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Participants will complete a questionnaire before using the product and on Days 3 and 7 of using the product. They will also complete a vaginal swab pH test before using the product and after 7 days of using the product (Day 8).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female at birth\n* Aged 18+\n* Interested in maintaining a calm, soothed, and healthy vaginal environment and balanced vaginal pH levels\n* Regularly experience atypical vaginal smell, discharge, itching, swelling, irritation, pain or - burning during sex, and/or a burning sensation while urinating\n* Willing to avoid introducing any products or new forms of prescription medication or supplements targeting vaginal health during the study period\n* Has used a boric acid suppository before\n* Willing to avoid the use of any intra-vaginal products during the study product use\n* Willing and able to follow the study protocol\n\nExclusion Criteria:\n\n* Surgeries or invasive treatments in the last six months or planned during the study period\n* Introduced any products or forms of prescription medication or supplements targeting vaginal health in the last 12 weeks\n* Known allergies to the product ingredients\n* Diagnosed with chronic health conditions impacting participation\n* Pregnant, breastfeeding, or trying to conceive\n* History of substance abuse\n* Current or former smoker within the past six months\n* Unwilling to follow the study protocol\n* Currently participating in any other clinical trial or perception study'}, 'identificationModule': {'nctId': 'NCT06516757', 'briefTitle': 'A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Love Wellness'}, 'officialTitle': 'A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health.', 'orgStudyIdInfo': {'id': '20412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Boric Acid Suppository Group', 'description': 'Participants will use 600 mg Boric Acid Gelatin Capsules (The Killer®) once daily for 7 consecutive days when they feel they are experiencing any signs of vaginal imbalance such as vaginal malodor, irritation, and/or itching.', 'interventionNames': ['Dietary Supplement: Boric Acid Suppository']}], 'interventions': [{'name': 'Boric Acid Suppository', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['The Killer®'], 'description': 'Participants will complete a baseline questionnaire and a vaginal pH test before using the product, and additional questionnaires and a pH test after 3 and 7 days of product use.', 'armGroupLabels': ['Boric Acid Suppository Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Love Wellness', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}