Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT05266651
Status:
UNKNOWN
Last Update Posted:
2022-03-04
First Post:
2022-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficiency of Tadalafil for Management of Female Sexual Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2022-02-22', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clitorial Artery Doppler', 'timeFrame': 'after one month duration of drug use', 'description': 'Pulsatile index'}, {'measure': 'Clitorial artery doppler', 'timeFrame': 'after one month duration of drug use', 'description': 'Resistance index'}, {'measure': 'Clitorial artery doppler', 'timeFrame': 'after one month duration of drug use', 'description': 'Peak systolic velosity'}], 'secondaryOutcomes': [{'measure': 'score of sexual function', 'timeFrame': 'after on month of the drug use', 'description': 'arousal orgasm frequency'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['female genital mutilation', 'Sexual dysfunction', 'Clitoral artery Doppler'], 'conditions': ['Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'comparative study between tadalafil versus placebo effect for the management of circumsized female', 'detailedDescription': 'the group of patient will be randomly divided into 2 groups, half of the patients will receive tadalafil and the other half will receive placebo'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female with history of female genital mutilation female with history of sexual dysfunction\n\nExclusion Criteria:\n\n* any medical disorder'}, 'identificationModule': {'nctId': 'NCT05266651', 'briefTitle': 'Efficiency of Tadalafil for Management of Female Sexual Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Efficiency of Tadalafil for Management of Female Sexual Dysfunction in Females With Genital Mutilation', 'orgStudyIdInfo': {'id': '22022022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tadalafil group', 'description': '5 mg of Tadalafil on daily bases for one month duration', 'interventionNames': ['Drug: Tadalafil 5mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'the patients will receive oral tablets without any active substance for one month', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tadalafil 5mg', 'type': 'DRUG', 'description': 'oral tablets for one month duration', 'armGroupLabels': ['tadalafil group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral tablets for one month duration', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Elainy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'the exel sheet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hussein Aly Hussein', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}