Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT04311658
Status:
UNKNOWN
Last Update Posted:
2020-03-17
First Post:
2020-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C030397', 'term': 'isosorbide-5-mononitrate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-07-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-14', 'studyFirstSubmitDate': '2020-03-14', 'studyFirstSubmitQcDate': '2020-03-14', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain during IUD insertion', 'timeFrame': '5 minutes', 'description': "intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 10 on a 10 cm horizontal straight line, where\n\n'zero' corresponds to no pain at all, and '10' to the worst possible pain imaginable."}], 'secondaryOutcomes': [{'measure': 'duration of IUD insertion', 'timeFrame': '5 minutes', 'description': 'duration of IUD insertion from speculum in to speculum out in minutes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'the aim of the study is to evaluate the safety and efficacy of isosorbide mononitrate vaginal administration in reducing pain during LNG-IUD insertion in adolescents and young women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adolescents and young women requesting LNG-IUD insertion\n\nExclusion Criteria:\n\n* heavy vaginal bleeding,pregnancy, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly'}, 'identificationModule': {'nctId': 'NCT04311658', 'briefTitle': 'Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion in Adolescents and Young Women', 'orgStudyIdInfo': {'id': 'isosorbide mononitrate IUDs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isosorbide Mononitrate', 'description': 'one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG-IUD insertion', 'interventionNames': ['Drug: Isosorbide Mononitrate 40 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'one tablet of placebo vaginally 3 hours prior to LNG- IUD insertion', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Isosorbide Mononitrate 40 MG', 'type': 'DRUG', 'description': 'one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG- IUD insertion', 'armGroupLabels': ['Isosorbide Mononitrate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'one tablet of placebo vaginally 3 hours prior to LNG-IUD insertion', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'AHMED SAMY', 'role': 'CONTACT', 'email': 'ahmedsamy8233@gmail.com', 'phone': '+201100681167'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor obstetrics and gynecology', 'investigatorFullName': 'Ahmed Samy aly ashour', 'investigatorAffiliation': 'Cairo University'}}}}