Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-25 @ 7:56 PM
Study NCT ID:
NCT02440750
Status:
UNKNOWN
Last Update Posted:
2016-03-09
First Post:
2015-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C023635', 'term': 'dienogest'}, {'id': 'C555622', 'term': 'ulipristal acetate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-08', 'studyFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endometrial thickness', 'timeFrame': 'Change in mm from baseline after farmacological therapy', 'description': 'We perform a transvaginal ultrasound (baseline) and we measure the maximum thickness of endometrial line; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm'}], 'secondaryOutcomes': [{'measure': 'Ovarian follicle dimensions', 'timeFrame': 'Change in mm from baseline after farmacological therapy', 'description': 'We perform a transvaginal ultrasound (baseline) and we measure the maximum diameter of follicles; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm'}, {'measure': 'Endometrial appearance', 'timeFrame': 'Change from baseline after farmacological therapy', 'description': 'We perform a diagnostic hysteroscopy (baseline) and we describe the endometrial appearance; at the time of surgery (operative hysteroscopy) we describe the endometrial appearance after pharmacological treatment'}, {'measure': 'Operative time', 'timeFrame': 'Within 2 hours after the end of the hysteroscopy', 'description': 'It will be expressed in minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uterine Fibroids']}, 'descriptionModule': {'briefSummary': 'The presence of a thin endometrium has an important role in allowing the best conditions for hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial preparation to operative hysteroscopy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis at office hysteroscopy of symptomatic submucous myomas with intramural development (G1 and G2)\n\nExclusion Criteria:\n\n* pregnancy\n* other hormonal therapy in the previous 8 weeks\n* hepatic or renal impairment\n* any medical condition that would increase the surgical risk\n* refusal or unable to sign written consent'}, 'identificationModule': {'nctId': 'NCT02440750', 'briefTitle': 'Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'orgStudyIdInfo': {'id': 'HYSTERO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dienogest', 'description': 'Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die', 'interventionNames': ['Procedure: operative hysteroscopy', 'Drug: Dienogest']}, {'type': 'EXPERIMENTAL', 'label': 'Ulipristal acetate', 'description': 'Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die', 'interventionNames': ['Procedure: operative hysteroscopy', 'Drug: Ulipristal acetate']}], 'interventions': [{'name': 'operative hysteroscopy', 'type': 'PROCEDURE', 'description': 'Performed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.', 'armGroupLabels': ['Dienogest', 'Ulipristal acetate']}, {'name': 'Dienogest', 'type': 'DRUG', 'otherNames': ['Visanne'], 'description': '21 days administration of dienogest 2 mg/die', 'armGroupLabels': ['Dienogest']}, {'name': 'Ulipristal acetate', 'type': 'DRUG', 'otherNames': ['Esmya'], 'description': '21 days administration of ulipristal acetate 5 mg/die', 'armGroupLabels': ['Ulipristal acetate']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stefano Angioni', 'investigatorAffiliation': 'University of Cagliari'}}}}