Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-02-05 @ 5:33 PM
Study NCT ID:
NCT05940233
Status:
RECRUITING
Last Update Posted:
2024-11-06
First Post:
2023-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.\n\nIn control group we give only Misoprostol 800 mcg SL.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2023-05-24', 'studyFirstSubmitQcDate': '2023-06-30', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of complete abortion', 'timeFrame': 'up to 7 days', 'description': 'Rate of complete abortion'}], 'secondaryOutcomes': [{'measure': 'Side effect between both group', 'timeFrame': 'up to 7 days', 'description': 'Number of patients with side effects between both group'}, {'measure': 'induced to abortion time between both group', 'timeFrame': 'up to 6 months', 'description': 'induced to abortion time between both group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Medical; Abortion, Fetus']}, 'descriptionModule': {'briefSummary': 'Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy', 'detailedDescription': 'Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy; RCT\n\nThis reseach focus on the medical abortion in the early pregnancy loss. The target population is 70 patients (35 per group). We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.\n\nIn control group we give only Misoprostol 800 mcg SL. Then, thepatien will follow up on day 7, TVS will be done to diagnose the complete abortion.\n\nThe primary outcome is rate of complete abortion between 2 groups. The secondary outcome is side effect of letrozole and induced to abortion time.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diafnoed Early pregnancy loss by TVS according to ACOG Practice bulletin 2018\n* GA \\<= 14 weeks\n* Os open \\<= 1 cm and no conceptus per os\n* Hematicrit \\>= 30\n* Systolic blood pressure \\>= 95 mmHg\n* Informed consent done and can follow up and comunicate in Thai language\n\nExclusion Criteria:\n\n* Allerguc to Letrozole or Misoprostol\n* Intrauterine contraceptive device use\n* Breast feeding\n* Diagnoed with ectopic pregnancy or undiagnoed adnexal mass\n* Severe or recurrent liver disease or AST or ALT more than or equal to 3 times of upper normal limit\n* Multiple pregnancy\n* Myoma uteri that involves the endometrium ex. Submucous myoma uteri\n* Thromboembolism or has a history of thromboembolism\n* Serum creatinine \\>= 2'}, 'identificationModule': {'nctId': 'NCT05940233', 'briefTitle': 'Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone', 'organization': {'class': 'OTHER', 'fullName': 'Queen Savang Vadhana Memorial Hospital, Thailand'}, 'officialTitle': 'Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone in First Trimester Pregnancy', 'orgStudyIdInfo': {'id': '014/2566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letrozole plus Misoprostol', 'description': 'We give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.', 'interventionNames': ['Drug: Letrozole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol', 'description': 'We give only Misoprostol 800 mcg SL.', 'interventionNames': ['Drug: Letrozole']}], 'interventions': [{'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': 'In the experimental group, we give the Letrozole 10 mg PO daily on the 4th day before Misoprostol 800 mcg SL on the 4th day. In the control group, we give Misoprostol 800 mcg SL on the 4th day.', 'armGroupLabels': ['Letrozole plus Misoprostol', 'Misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10120', 'city': 'Bangkok', 'state': 'Yannawa', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Sutinee Srimahachota', 'role': 'CONTACT', 'email': 'srimahachota@gmail.com', 'phone': '0847202666'}], 'facility': 'Sutinee Srimahachota', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Sutinee Srimahachota, M.D.', 'role': 'CONTACT', 'email': 'srimahachota@gmail.com', 'phone': '0847202666'}, {'name': 'Chuenrutai Yeekian, Ph.D.', 'role': 'CONTACT', 'email': 'jayeekian88@gmail.com', 'phone': '0818624534'}], 'overallOfficials': [{'name': 'ชื่นฤทัย ยี่เขียน, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Queen Savang Vadhana Memorial Hospital, Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Savang Vadhana Memorial Hospital, Thailand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}