Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 1:53 AM
Study NCT ID:
NCT04270994
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2020-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expulsion rate of endometrial polyps', 'timeFrame': '7 days after misoprostol has been applied'}], 'secondaryOutcomes': [{'measure': 'Pregnancy rate after expulsion', 'timeFrame': '14-21 days after positive β-human Chorionic Gonadotropin (β-hCG)'}, {'measure': 'The pregnancy rate after expulsion in patients with primary sterility', 'timeFrame': '14-21 days after positive β-hCG'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Polyps in Infertile Patients']}, 'descriptionModule': {'briefSummary': 'Endometrial polyps are one of the main causes of infertility in women. In this work we propose an alternative, effective, economical and safe treatment: the use of misoprostol', 'detailedDescription': 'The prevalence of uterine polyps has been estimated in the general population at 10-15%, while in infertile patients it ranges from 6-32%. Its etiology is considered as multifactorial. Polyps induce a local inflammatory response in the endometrial cavity, causing infertility. The treatment of choice considered "gold standard" is the excision by hysteroscopy, however, improvement has been shown in patients with conservative management due to the regression rate of 27%. There are no recommended drugs to provide a definitive treatment for uterine polyps. Misoprostol is a synthetic analogue derived from prostaglandin E1 that has stimulating effects on the smooth muscle fibers of the uterus, causing contractions of the myometrium, which cause endouterine evacuation. The present study shows a possible utility of misoprostol for the conservative treatment of uterine polyps.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with uterine polyps diagnosed by endovaginal ultrasound and/or hysterosonography, female ≤ 45 years of age\n\nExclusion Criteria:\n\n* Patients older than 45 years, polyps larger than 60 mm, who did not perform surveillance and/or minimum assessment 6 months after medical management'}, 'identificationModule': {'nctId': 'NCT04270994', 'briefTitle': 'Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients', 'organization': {'class': 'INDIV', 'fullName': 'Mateo-Sánez, Henry A.'}, 'officialTitle': 'Misoprotol as a Treatment for Endometrial Polyps in Infertile Patients', 'orgStudyIdInfo': {'id': 'MSP_2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Misoprostol', 'interventionNames': ['Drug: Misoprostol']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'armGroupLabels': ['Misoprostol']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'HENRY A MATEO-SÁNEZ, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Henry Aristoteles Mate-Sánez'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Aristoteles Mate-Sánez', 'class': 'INDIV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Henry Aristoteles Mate-Sánez', 'investigatorAffiliation': 'Mateo-Sánez, Henry A.'}}}}