Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 9:55 PM
Study NCT ID:
NCT05198050
Status:
COMPLETED
Last Update Posted:
2023-09-11
First Post:
2022-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Letrozole in Induction of Abortion of Anembryonic Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D000527', 'term': 'Alprostadil'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011458', 'term': 'Prostaglandins E'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-19', 'lastUpdatePostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete abortion', 'timeFrame': '2 days', 'description': 'no emergency or elective curettage was necessary until next menstruation'}], 'secondaryOutcomes': [{'measure': 'Induction-to-abortion interval', 'timeFrame': '2 days', 'description': 'the interval between administration of misoprostol)'}, {'measure': 'Adverse effects of Misoprostol', 'timeFrame': '2 days', 'description': 'diarrhea, abdominal cramps, fever and sweating.'}, {'measure': 'Adverse effects of Letrozole', 'timeFrame': '2 days', 'description': 'hot flushes, drowsiness and nausea.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Letrozole', 'misoprostol', 'induction of abortion'], 'conditions': ['Anembryonic Pregnancy']}, 'referencesModule': {'references': [{'pmid': '21693030', 'type': 'BACKGROUND', 'citation': 'Fouda UM, Sayed AM. Extended letrozole regimen versus clomiphene citrate for superovulation in patients with unexplained infertility undergoing intrauterine insemination: a randomized controlled trial. Reprod Biol Endocrinol. 2011 Jun 21;9:84. doi: 10.1186/1477-7827-9-84.'}, {'pmid': '30647756', 'type': 'BACKGROUND', 'citation': 'Abbasalizadeh F, Sahhaf F, Sadeghi-Shabestari P, Mirza-Aghazadeh-Attari M, Naghavi-Behzad M. Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial. J Family Reprod Health. 2018 Mar;12(1):27-33.'}, {'pmid': '21252745', 'type': 'BACKGROUND', 'citation': 'Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-323. doi: 10.1097/AOG.0b013e3182073fbf.'}, {'pmid': '22302719', 'type': 'BACKGROUND', 'citation': 'Lee VC, Yeung TW, Tang OS, Ng EH, Yeung WS, Ho PC. Effect of letrozole on uterine artery Doppler flow indices prior to first-trimester termination of pregnancy: a randomized controlled trial. Ultrasound Obstet Gynecol. 2012 Oct;40(4):392-7. doi: 10.1002/uog.11115.'}]}, 'descriptionModule': {'briefSummary': 'Some studies suggest the prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion. the aim of the study is to compare the effectiveness of various regimens of letrozole combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with blighted ovum.', 'detailedDescription': 'Some studies suggest prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion, increases the efficiency of the treatment regimen and also decreases the need for surgical interventions. Some conducted studies have mentioned reinforcing the impact of misoprostol with letrozole, but reaching the ideal dose still needs more studies, so in this study, the investigators will compare the effectiveness of various regimens of letrozole ( 10 mg/d for 3 days or a single dose of 20 mg) combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with a blighted ovum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first trimester of pregnancy\n* pregnancy duration less than 12 weeks based on LMP.\n* non-viable fetus (blighted ovum)\n\nExclusion Criteria:\n\n* No heart disease,\n* No asthma\n* No History of thromboembolism\n* No History of cancer\n* No renal failure\n* No liver diseases\n* History of allergy to misoprostol or letrozole drugs.'}, 'identificationModule': {'nctId': 'NCT05198050', 'briefTitle': 'Letrozole in Induction of Abortion of Anembryonic Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Letrozole Plus Misoprostol Versus Misoprostol Alone in Induction of Abortion of Anembryonic Pregnancy:', 'orgStudyIdInfo': {'id': 'Letrozole and abortion'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'single dose letrozole tablets', 'description': 'starting from the first of January, patients will receive a single dose of letrozole (20 mg) two days, before starting misoprostol administration. Placebo tables with a similar appearance to letrozole will be administered the day before misoprostol administration and on the day of misoprostol administration.', 'interventionNames': ['Drug: Letrozole tablets', 'Drug: Misoprostol Tabets', 'Drug: Placebo tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'multiple dose letrozole tablets', 'description': 'starting from the first of January, patients will receive 10 mg letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.', 'interventionNames': ['Drug: Letrozole tablets', 'Drug: Misoprostol Tabets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'misoprostol tablets', 'description': 'starting from the first of January, patients will receive placebo tablets with a similar appearance to letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.', 'interventionNames': ['Drug: Misoprostol Tabets', 'Drug: Placebo tablets']}], 'interventions': [{'name': 'Letrozole tablets', 'type': 'DRUG', 'description': 'Letrozole is a third-generation non-steroidal aromatase inhibitor', 'armGroupLabels': ['multiple dose letrozole tablets', 'single dose letrozole tablets']}, {'name': 'Misoprostol Tabets', 'type': 'DRUG', 'otherNames': ['prostaglandin E1'], 'description': 'a synthetic prostaglandin medication', 'armGroupLabels': ['misoprostol tablets', 'multiple dose letrozole tablets', 'single dose letrozole tablets']}, {'name': 'Placebo tablets', 'type': 'DRUG', 'description': 'Placebo tables with a similar appearance to letrozole', 'armGroupLabels': ['misoprostol tablets', 'single dose letrozole tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Marwa M Abdalla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasralainy teaching hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor of Obstetrics and Gynecology', 'investigatorFullName': 'Marwa Mohamed Abdalla', 'investigatorAffiliation': 'Cairo University'}}}}