Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-29 @ 7:48 PM
Study NCT ID:
NCT04312061
Status:
UNKNOWN
Last Update Posted:
2020-03-18
First Post:
2020-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oral Tramadol Administration Prior to IUD Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, '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': 108}}, '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': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', '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 the procedure', '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 oral tramadol 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* nulliparous adolescents and young women requesting LNG-IUD insertion\n\nExclusion Criteria:\n\n* parous women, contraindications to LNG-IUD insertion and allergy or contraindications to tramadol'}, 'identificationModule': {'nctId': 'NCT04312061', 'briefTitle': 'Effect of Oral Tramadol Administration Prior to IUD Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Safety and Efficacy of Oral Tramadol Administration in Reducing Pain During Levonorgestrel Intrauterine Device Insertion in Adolescents and Young Women: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'tramadol IUD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oral tramadol', 'description': 'oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion', 'interventionNames': ['Drug: oral tramadol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'oral placebo tablet given 1 hour before LNG-IUD insertion', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'oral tramadol', 'type': 'DRUG', 'description': 'oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion', 'armGroupLabels': ['oral tramadol']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'oral placebo tablet given 1 hour before 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'}}}}