Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-26 @ 2:58 PM
Study NCT ID:
NCT05800392
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2023-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of DEC103 in Pain Control Associated to Intrauterine Device (IUD) Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.', 'timeFrame': 'During the procedure.', 'description': 'Mean pain during the IUD insertion procedure during IUD deployment. The pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 (no pain) to 10 (worst pain possible).'}, {'measure': 'Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.', 'timeFrame': 'During the procedure.', 'description': 'Mean overall pain rating during the IUD insertion procedure. The pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 (no pain) to 10 (worst pain possible).'}, {'measure': 'Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.', 'timeFrame': '10 minutes after de procedure.', 'description': 'Mean pain 10 minuts after the IUD insertion The pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 (no pain) to 10 (worst pain possible).'}], 'secondaryOutcomes': [{'measure': 'Efficacy of DEC103 in pain associated to IUD insertion assessed by NRS.', 'timeFrame': 'During the procedure.', 'description': 'Mean pain during tenaculum placement and uterine sounding. The pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 (no pain) to 10 (worst pain possible).'}, {'measure': "Women's overall pain perception during the procedure assessed by a 4-point scale.", 'timeFrame': 'During the procedure.', 'description': 'The global pain perception during the procedure will be assessed through a 4-point scale as the following: 0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = intense pain'}, {'measure': "Physician's perception regarding ease of IUD insertion assessed by the following options: easy, moderate and difficult.", 'timeFrame': 'Immediately after the procedure.', 'description': "Physician's perception will be assessed through a questionnaire with the following options: easy, moderate and difficult."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'IUD insertion'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of DEC103 in the pain control associated with IUD insertion in women with 18 to 49 years.', 'detailedDescription': 'The DEC103 treatment is composed by two different medications that are already available in brazilian market. One is a sublingual pill and the other is an oral one. The participants must take 02 (two) pills of the sublingual formulation and 01 (one) of the oral formulation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has given written informed consent to participate in the study prior to admission;\n* Female patients aged between 18 and 49 years old;\n* First IUD users;\n* Nulliparous women.\n\nExclusion Criteria:\n\n* Any finding or clinical observation (clinical/physical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or presence of uncontrolled chronic disease(s);\n* Presence of chronic pelvic pain and any uterine malformation;\n* Presence of psychiatric disorder;\n* Chronic use of medications that interfere with the pain threshold, for example: antidepressants and anticonvulsants;\n* Use of analgesics and/or ant-inflammatory in the last 24 hours prior the procedure;\n* Any sign or symptom of vaginal or cervical infection;\n* Participants with any contraindication to one or both medicines that constitute the DEC103 treatment;\n* Actual abuse of alcohol or drugs;\n* Participants who are nursing;\n* Presence of known allergy or hypersensitivity to the components of the drugs used during the clinical trial;\n* Participants with a current medical history of cancer and/or cancer treatment in the last five (05) years;\n* Participation in a clinical research protocol in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit to it.'}, 'identificationModule': {'nctId': 'NCT05800392', 'acronym': 'DEC103', 'briefTitle': 'Efficacy and Safety of DEC103 in Pain Control Associated to Intrauterine Device (IUD) Insertion', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'A National, Single Center, Randomized, Prospective, Phase IV, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of DEC103 in the Pain Control Associated With Intrauterine Device (IUD) Insertion', 'orgStudyIdInfo': {'id': 'DEC103-IV-0123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'DEC103: The participants will take 02 (two) pills of the sublingual formulation and 01 (one) pill of the oral one, 1 hour prior the IUD insertion.', 'interventionNames': ['Drug: DEC103']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'PLACEBO DEC103: The participants will take 02 (two) pills of the placebo sublingual formulation and 01 (one) pill of the placebo oral one, 1 hour prior the IUD insertion.', 'interventionNames': ['Drug: Placebo DEC103']}], 'interventions': [{'name': 'DEC103', 'type': 'DRUG', 'description': 'The intervention is composed by two medications: An active sublingual pill and an active oral one.', 'armGroupLabels': ['Experimental']}, {'name': 'Placebo DEC103', 'type': 'DRUG', 'description': 'The intervention is composed by two medications: A placebo sublingual pill and an placebo oral one.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Luis G Bahamondes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Research on Reproductive Health of Campinas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}