Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT00260767
Status:
UNKNOWN
Last Update Posted:
2005-12-02
First Post:
2005-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 6}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'lastUpdateSubmitDate': '2005-11-30', 'studyFirstSubmitDate': '2005-11-30', 'studyFirstSubmitQcDate': '2005-11-30', 'lastUpdatePostDateStruct': {'date': '2005-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Number and size of bare spots, before and after simulated coitus.'}, {'measure': '2. Number of women with migration of gel into the endocervical canal and/or endometrial canal before and after simulated coitus.'}]}, 'conditionsModule': {'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI.', 'detailedDescription': 'This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI. MRIs will be performed with both a standard pelvic coil and an enhanced resolution endo-rectal coil in order to obtain maximal resolution. MRI images will be acquired before and after simulated coitus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 45 year old women\n* not pregnant\n* willingness to use effective method of contraception\n* regular menstrual cycle\n* normal Pap test result\n\nExclusion Criteria:\n\n* abnormal pelvic exam\n* pregnant or breastfeeding\n* claustrophobia or other MRI contraindications\n* hypertension, hemolytic anemia,latex allergy\n* history of hemorrhoids or irritable bowel syndrome'}, 'identificationModule': {'nctId': 'NCT00260767', 'briefTitle': 'Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosyn'}, 'officialTitle': 'An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution', 'orgStudyIdInfo': {'id': 'RRU009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HEC placebo gel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Kurt Barnhart, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Reproductive Research Unit, U of Penn Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Kurt Barnhart, MD', 'role': 'CONTACT', 'phone': '215 662 2974'}], 'overallOfficials': [{'name': 'Kurt Barnhart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosyn', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}]}}}