Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT03779633
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2018-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-09-30', 'releaseDate': '2021-09-02'}], 'estimatedResultsFirstSubmitDate': '2021-09-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind, Placebo-controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2018-07-29', 'studyFirstSubmitQcDate': '2018-12-16', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'subjective prolapse associated symptoms (measured with the validated German pelvic floor questionnaire)', 'timeFrame': 'change from baseline POP Score at 6 weeks after treatment', 'description': 'treatment efficacy of preoperative vaginally administered oestrogen in postmenopausal women with symptomatic pelvic organ prolapse in comparison to placebo, measured by a subjective questionnaire. 42 questions. Range 0 to 3 points for each question. Lower values represent a better outcome'}], 'secondaryOutcomes': [{'measure': 'operative time in minutes', 'timeFrame': 'up to 1 week postoperative', 'description': 'effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo'}, {'measure': 'length of stay in days', 'timeFrame': 'up to 1 week postoperative', 'description': 'effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo'}, {'measure': 'intraoperative blood loss in ml', 'timeFrame': 'up to 1 week postoperative', 'description': 'effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo'}, {'measure': 'blood circulation of the tissue (good, regular, scarce, no blood circulation)', 'timeFrame': 'on day of surgery', 'description': 'differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation'}, {'measure': 'separability of the tissue layers (good, regular, scarce, not possible)', 'timeFrame': 'on day of surgery', 'description': 'differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation'}, {'measure': 'easy separation from the bladder (yes/no)', 'timeFrame': 'on day of surgery', 'description': 'differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation'}, {'measure': 'easy opening of the Douglas cavity (Yes/no)', 'timeFrame': 'on day of surgery', 'description': 'differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation'}, {'measure': 'subjective (all domains of the pelvic floor questionnaire) outcome 3 months postoperative', 'timeFrame': '3 months postoperative', 'description': 'possible differences regarding subjective outcome parameters between intervention and placebo-group 3 months after operation. 42 questions. Range 0 to 3 points for each question. Lower values represent a better outcome.'}, {'measure': 'objective (POP-Q score) outcome 3 months postoperative', 'timeFrame': '3 months postoperative', 'description': 'possible differences regarding objective outcome parameters between intervention and placebo-group 3 months after operation. POP-Q Score (Score between 0 and 4). The POP- quantification system consists of six defined points of measurement (Aa, Ba, C,D,Ap,Bp) and three other landmarks (GH,TVL, PB). Each is measured in centimeters above the hymen (negative number) or below the hymen (positive number).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Local Oestrogen'], 'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '26383760', 'type': 'BACKGROUND', 'citation': 'Weber MA, Kleijn MH, Langendam M, Limpens J, Heineman MJ, Roovers JP. Local Oestrogen for Pelvic Floor Disorders: A Systematic Review. PLoS One. 2015 Sep 18;10(9):e0136265. doi: 10.1371/journal.pone.0136265. eCollection 2015.'}, {'pmid': '24947034', 'type': 'BACKGROUND', 'citation': 'Rahn DD, Good MM, Roshanravan SM, Shi H, Schaffer JI, Singh RJ, Word RA. Effects of preoperative local estrogen in postmenopausal women with prolapse: a randomized trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3728-36. doi: 10.1210/jc.2014-1216. Epub 2014 Jun 20.'}, {'pmid': '37431855', 'type': 'DERIVED', 'citation': 'Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.'}, {'pmid': '35443258', 'type': 'DERIVED', 'citation': 'European Urogynaecological Association 2021 Annual Meeting | Hybrid Edition. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):244-271. doi: 10.1097/SPV.0000000000001172. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Introduction With increasing age the incidence of pelvic organ prolapse (POP) rises and will increase substantially in the future according to forecasting studies. It is possible that oestrogens, alone or in combination with other forms of therapy, may assist in the management of POP by increasing collagen synthesis and thereby improving the strength of the weakened vaginal epithelium. Yet, studies investigating the effect of topical oestrogen and its impact on POP associated symptoms, both self-reported improvement and observations of objective improvement, are lacking.\n\nObjective To evaluate the subjective efficacy concerning prolapse associated complaints measured by the German pelvic floor questionnaire (domain POP: POP-score) after preoperative use of local oestrogen compared to preoperative placebo treatment in postmenopausal women with symptomatic pelvic organ prolapse. Further variables of interest are POP-score after 3 months, differences regarding the objective prolapse quantification system (POP-Q), surgical outcome and tissue operability assessed by the surgeon.\n\nMethods In this prospective, randomized, double-blind, placebo-controlled, multicenter study the investigators aim to include 120 postmenopausal women with symptomatic pelvic organ prolapse and indicated operative procedure. An analysis of covariance will be computed with the depending variable POP-score after 6 weeks and the independent variables group (verum versus placebo) and Pop-Score at baseline.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women\n* Able to read, understand and sign informed consent\n* Able to apply a vaginal cream\n* Symptomatic pelvic organ prolapse with planned and indicated prolapse surgical repair\n\nExclusion Criteria:\n\n* Suspicion or history of breast cancer or other oestrogen responsive malignancies (endometrial cancer)\n* unexplained abnormal vaginal bleeding\n* history of deep vein thrombosis\n* inherited or acquired blood clotting disorders (eg, APC resistance, Antithrombin III deficiency)\n* transient ischaemic attack, myo- cardial infarction or ischaemic heart disease\n* Hypersensitivity to oestrogen\n* Unable to read and sign informed consent'}, 'identificationModule': {'nctId': 'NCT03779633', 'briefTitle': 'Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Preoperative Locally Applied Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse: Changes in Subjective and Objective Outcome - a Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study', 'orgStudyIdInfo': {'id': 'EstrogenPOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Linoladiol Estradiol', 'description': 'Linoladiol Estradiol cream 6 weeks before surgery of pelvic organ prolapse', 'interventionNames': ['Drug: Linoladiol Estradiol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo cream 6 weeks before surgery of pelvic organ prolapse', 'interventionNames': ['Other: Placebo vaginal cream']}], 'interventions': [{'name': 'Linoladiol Estradiol', 'type': 'DRUG', 'otherNames': ['Montavit ATC Code G03CA03'], 'description': 'Linoladiol Estradiol Initial dose (week 1): 1 application (2g Linoladiol = 0.2mg Estradiol) every day for the first week Maintenance dose 1 (week 2) : 1 application (2g Linoladiol = 0.2mg Estradiol) every 48 hours the following week.\n\nMaintenance dose 2 (week 3-6): 1 application (2g Linoladiol = 0.2mg Estradiol) twice per week the following 4 weeks.\n\nRoute of administration: intravaginally by means of a calibrated applicator before retiring at night Duration: 6 weeks', 'armGroupLabels': ['Linoladiol Estradiol']}, {'name': 'Placebo vaginal cream', 'type': 'OTHER', 'description': 'Initial dose (week 1): 1 application every day for the first week Maintenance dose 1 (week 2) : 1 application every 48 hours the following week.\n\nMaintenance dose 2 (week 3-6): 1 application twice per week the following 4 weeks.\n\nRoute of administration: intravaginally by means of a calibrated applicator before retiring at night Duration: 6 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3430', 'city': 'Tulln', 'country': 'Austria', 'facility': 'Department of Obstetrics and Gynecology, University of Tulln', 'geoPoint': {'lat': 48.32829, 'lon': 16.05858}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Department of General Gynecology and Gynecologic Oncology of the Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Barbara Bodner-Adler', 'investigatorAffiliation': 'Medical University of Vienna'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-09-02', 'type': 'RELEASE'}, {'date': '2021-09-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Barbara Bodner-Adler, Clinical Professor, Medical University of Vienna'}}}}