Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-26 @ 11:11 PM
Study NCT ID:
NCT06577168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-29
First Post:
2024-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean number of days with menstrual bleeding changes', 'timeFrame': 'Six months after insertion of levonogestrel Intrauterine system', 'description': 'This include calculating the average number of days per month with bleeding-only, spotting-only,and bleeding and/or spotting in reproductive aged women using a 52 mg levonogestrel Intrauterine system (LNG-IUS) within the first six months ofuse, according to World Health Organization standards.'}]}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '31589865', 'type': 'BACKGROUND', 'citation': 'Maldonado LY, Sergison JE, Gao X, Hubacher D. Menstrual bleeding and spotting with the Levonorgestrel Intrauterine System (52 mg) during the first-year after insertion: a systematic review and meta-analysis. Am J Obstet Gynecol. 2020 May;222(5):451-468.e9. doi: 10.1016/j.ajog.2019.09.044. Epub 2019 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to systematically calculate the mean number of bleeding-only, spotting-only, and bleeding and/or spotting days experienced by a population of reproductive aged,52 mg levonogestrel Intrauterine System(LNG-IUS) users.', 'detailedDescription': 'The levonogestrel Intrauterine system (LNG-IUS)(52 mg per 20mg per day release) is associated with medically benign changes to the menstrual pattern. Amenorrhea, the complete cessation of vaginal bleeding for at least 90 consecutive days, is perhaps the most extreme bleeding pattern experienced by some users during the first year. Amenorrhea prevalence is positively associated with duration of use, with approximately 8% of users.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Females at reproductive age (18-45)', 'genderDescription': 'Females in reproductive age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Included participants with normal regular menses prior to LNG-IUS\n\ninsertion\n\n* Included participants of any age, race, ethnicity, or parity\n* Contained bleeding and/or spotting data on the 52 mg (20 mg/d) LNG-IUS\n* Collected daily menstrual bleeding data from written diaries for at least 90 consecutive days\n\nExclusion Criteria:\n\n* Heavy or prolonged menstrual bleeding (menorrhagia)\n* Actively breastfeeding\n* Hormonal long-acting reversible contraceptive method (LNG-IUS, implant) within 3 months of enrollment\n* Hormonal injectable contraceptive use within 6 months of enrollment\n* First 3 months (90 days) of data from women with postpartum or postabortion LNG-IUS insertions\n* Any anatomical or pathological condition (ie, uterine fibroids) that may have an impact on baseline menstrual bleeding pattern'}, 'identificationModule': {'nctId': 'NCT06577168', 'briefTitle': 'Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Prevalence and Predictors of Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion.', 'orgStudyIdInfo': {'id': 'Contraception'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Levonogestrel Intrauterine system (LNG-IUS)', 'type': 'OTHER', 'description': 'Contraception method'}]}, 'contactsLocationsModule': {'locations': [{'zip': '088', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Lotfy', 'role': 'CONTACT', 'email': 'mariomasamy90@gmail.com', 'phone': '+20 01220270988'}], 'facility': 'Assuit University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mariam S Lotfy', 'role': 'CONTACT', 'email': 'mariomasamy90@gmail.com', 'phone': '+20 01220270988'}, {'name': 'Ahmed M Alaa eldin, Professor', 'role': 'CONTACT', 'email': 'Ahmedalla11282.eg@gmail.com', 'phone': '+20 01006184921'}], 'overallOfficials': [{'name': 'Seif E Ahmed, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Mariam Samy Lotfy', 'investigatorAffiliation': 'Assiut University'}}}}