Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-02 @ 4:20 PM
Study NCT ID:
NCT06324851
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2024-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014591', 'term': 'Uterine Diseases'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718213', 'term': 'drospirenone and estetrol'}, {'id': 'C038501', 'term': 'nomegestrol acetate'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'C023635', 'term': 'dienogest'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of endometrial preparation', 'timeFrame': '14th day of treatment', 'description': 'Quality of endometrial preparation assessed visually intraoperatively by the surgeon using a visual analog scale from 0 to 5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hysteroscopy', 'Endometrial preparation'], 'conditions': ['Endometrial Polyp', 'Endometrial Diseases']}, 'descriptionModule': {'briefSummary': 'The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Drospirenone/Estetrol or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with endometrial polyps.\n\nExclusion Criteria:\n\n* Patients with other endometrial pathologies.'}, 'identificationModule': {'nctId': 'NCT06324851', 'briefTitle': 'The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study', 'orgStudyIdInfo': {'id': 'DROVZOEFFIPREP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drospirenone/Estetrol', 'description': 'Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Drospirenone/Estetrol at any time of the menstrual cycle', 'interventionNames': ['Drug: Drospirenone / Estetrol']}, {'type': 'EXPERIMENTAL', 'label': 'Nomegestrol Acetate/Estradiol', 'description': 'Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Nomegestrol Acetate/Estradiol at any time of the menstrual cycle', 'interventionNames': ['Drug: Nomegestrol Acetate / Estradiol']}, {'type': 'EXPERIMENTAL', 'label': 'Ethinylestradiol/Dienogest', 'description': 'Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest at any time of the menstrual cycle', 'interventionNames': ['Drug: Ethinylestradiol / Dienogest']}], 'interventions': [{'name': 'Drospirenone / Estetrol', 'type': 'DRUG', 'description': 'Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Drospirenone/Estetrol at any time of the menstrual cycle', 'armGroupLabels': ['Drospirenone/Estetrol']}, {'name': 'Nomegestrol Acetate / Estradiol', 'type': 'DRUG', 'description': 'Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Nomegestrol Acetate/Estradiol at any time of the menstrual cycle', 'armGroupLabels': ['Nomegestrol Acetate/Estradiol']}, {'name': 'Ethinylestradiol / Dienogest', 'type': 'DRUG', 'description': 'Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest at any time of the menstrual cycle', 'armGroupLabels': ['Ethinylestradiol/Dienogest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90123', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Andrea Etrusco', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Marco Monti', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Palermo', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Roma La Sapienza', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Andrea Etrusco', 'investigatorAffiliation': 'University of Palermo'}}}}