Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-27 @ 7:04 AM
Study NCT ID:
NCT01419392
Status:
UNKNOWN
Last Update Posted:
2012-04-17
First Post:
2011-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000026', 'term': 'Abortion, Habitual'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-04-14', 'studyFirstSubmitDate': '2011-08-17', 'studyFirstSubmitQcDate': '2011-08-17', 'lastUpdatePostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uterine arteries blood flow', 'timeFrame': '21 days', 'description': 'Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index'}], 'secondaryOutcomes': [{'measure': 'Nitric oxide serum level as a marked of oxidative stress', 'timeFrame': '21 days'}, {'measure': 'Total antioxidant capacity serum level as a marker of oxidative stress', 'timeFrame': '21 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sildenafil citrate', 'Doppler Ultrasonography', 'nitric oxide', 'total antioxidant capacity'], 'conditions': ['Recurrent Miscarriage']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether sildenafil citrate is effective in improving uterine artery blood flow and oxidative stress in patients with unexplained recurrent miscarriages'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-35 years\n* Three or more recurrent miscarriages before the 24th week of gestation with no apparent cause for their previous losses\n* Three or more months have elapsed since the last abortion\n* Postmenstrual period\n* No other therapy allowed during our treatment course\n\nExclusion Criteria:\n\n* Concomitant use of organic nitrites, or nitrates\n* Severe hepatic, renal, or cardiovascular impairment\n* History of stroke or myocardial infarction\n* Patients with retinitis pigmentosa.'}, 'identificationModule': {'nctId': 'NCT01419392', 'briefTitle': 'Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Ahmed-2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sildenafil citrate', 'interventionNames': ['Drug: Sildenafil citrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: matching placebo']}], 'interventions': [{'name': 'Sildenafil citrate', 'type': 'DRUG', 'otherNames': ['Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt'], 'description': '25 mg orally, 4 times per day for 21 days', 'armGroupLabels': ['Sildenafil citrate']}, {'name': 'matching placebo', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'orally, 4 times per day for 21 days', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology', 'investigatorFullName': 'Tamer El-Refaie', 'investigatorAffiliation': 'Ain Shams University'}}}}