Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-29 @ 7:14 PM
Study NCT ID:
NCT05174195
Status:
TERMINATED
Last Update Posted:
2021-12-30
First Post:
2021-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized prospective'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'whyStopped': 'difficult recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-29', 'studyFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerance of Implanon', 'timeFrame': 'at 1 year after implant insertion (or at ablation)', 'description': 'self-reported'}], 'secondaryOutcomes': [{'measure': 'Discontinuation of implant,', 'timeFrame': 'at any time after insertion through study completion, an average of 1 year', 'description': 'frequency of ablation of any cause and due to intolerance\n\n* severity of specific symptoms at 1 year (or at ablation)\n* severity of specific symptoms at 1 year (or at ablation)'}, {'measure': 'specific symptoms', 'timeFrame': 'at 1 year after implant insertion', 'description': 'measured by questionnaires on bleeding patterns and satisfaction on a Likert scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception', 'Progestogen Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '36915205', 'type': 'DERIVED', 'citation': 'Lombardi Fah V, Catarino R, Castillo S, Badda M, Gezer-Dickschat S, Thieringer F, Tschudin S, Viviano M, Yaron M. Can a 3 months treatment with oral Desogestrel prior to insertion of the etonogestrel-releasing contraceptive implant improve continuation rate at 1 year? A randomized trial. BMC Res Notes. 2023 Mar 13;16(1):35. doi: 10.1186/s13104-023-06304-3.'}]}, 'descriptionModule': {'briefSummary': "Objective: The etonogestrel subdermal implant (ESI) is an effective and safe method of contraception. Although highly efficient, ESI produces often side effects that reduce its tolerance and acceptance. Daily oral desogestrel (DSG) prior to the insertion of ESI might help reduce its premature discontinuation. Our aim was to evaluate if this pre-treatment increases ESI's tolerance.\n\nMethods: Between 15.08.2016 and 30.09.2019, the investigators conducted a randomized prospective study of women aged 18 to 42 years who were interested to use Implanon and were willing to have 90 days of pre-treatment with DSG, in the family planning clinic of the Geneva University Hospitals and the Hospital of Basel. Women were randomized into either the study ESI only group or to the DSG + ESI group. In the DSG + ESI group, patients were given a 3 months' supply of 75µg of DSG before the insertion of the ESI.\n\nA 3 months visit was pre-programmed for all participants where the bleeding calendar and the questionnaires were collected. All patients were called over the phone after 12 months post ESI insertion in both groups.", 'detailedDescription': 'Study and treatment periods\n\n1 year of patient recruitment 15 months of follow up (90 days OD plus 1 year Implant or 1 year Implant)\n\nMeasurements and Procedures:\n\nAssessment of premature ablation (PA) in months 3-12 (ESI only) or 3-15 (OD+ESI). This will require a contact with all patients at 12/15 months to verify if implant is still in place, and if it was removed, why (and possibly to also reassess symptoms).\n\nWomen with known PA can be exempted from this follow-up. In case of PA, reasons will be explored and questioned.\n\n* Assessment of symptoms at 3 months only (bleeding calendar and satisfaction questionnaire, see below)\n* Assessment of willingness to receive implant at 3 months in OD+ESI group data collection is limited to these items, in order to limit burden on participants, and to focus resources on high quality of data (as opposed to quantity).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Women age of 18 - 42 years\n* Interested in the use of ESI\n* Accepting to have 90 days pre-treatment with OD\n* Signed informed consent\n\nExclusion criteria:\n\n* Pregnancy\n* Lactation,\n* vaginal bleeding of unknown origin,\n* wish to become pregnant,\n* weight over 80 kg,\n* history of deep vein thrombosis/Pulmanory embolism,\n* hypertension,\n* Diabetes or other metabolic diseases,\n* coagulation disorders,\n* severe hepatic disorder,\n* history of breast/endometrial cancer,\n* known hypersensitivity to study drug,\n* current treatment with enzyme inducing drugs (e.g.: phenytoin, carbamazepine, phenobarbital, etc.)'}, 'identificationModule': {'nctId': 'NCT05174195', 'briefTitle': 'Does Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Can a Three Months Treatment With Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?', 'orgStudyIdInfo': {'id': 'CCER 16-972'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESI (Implanon NXT® subdermal implant)', 'description': 'In this group, the implant was inserted immediately after thorough explanations of the potential side effects and possible adverse events', 'interventionNames': ['Drug: Implanon NXT® subdermal implant']}, {'type': 'EXPERIMENTAL', 'label': 'DSG + ESI(Desogestrel +Implanon NXT® subdermal implant)', 'description': "In this group, patients were given a 3 months' supply of 75µg of DSG to be started immediately after which insertion of an ESI was proposed. Similarly, explanations of the potential side effects and possible adverse events were presented to the patient before treatment initiation.", 'interventionNames': ['Drug: Desogestrel 0.075 milligram', 'Drug: Implanon NXT® subdermal implant']}], 'interventions': [{'name': 'Desogestrel 0.075 milligram', 'type': 'DRUG', 'otherNames': ['Implanon NXT® subdermal implant'], 'description': 'Inserted after 3 months use of DESOGESTREL', 'armGroupLabels': ['DSG + ESI(Desogestrel +Implanon NXT® subdermal implant)']}, {'name': 'Implanon NXT® subdermal implant', 'type': 'DRUG', 'description': 'Inserted immediately', 'armGroupLabels': ['DSG + ESI(Desogestrel +Implanon NXT® subdermal implant)', 'ESI (Implanon NXT® subdermal implant)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Unit Ambulatory Gynecology', 'investigatorFullName': 'Michal Yaron', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}