Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT05742503
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2022-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}, {'id': 'C044815', 'term': 'etonogestrel'}, {'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D016912', 'term': 'Levonorgestrel'}], 'ancestors': [{'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level', 'timeFrame': 'Six mounths', 'description': 'The effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Progesterone', 'Contraceptive Methods']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level', 'detailedDescription': "Progestogen-only' contraceptives are presented as injections, implants, oral formulations, hormone-releasing intrauterine methods and emergency contraceptives. These substances could be used by females who are breastfeeding or have other contraindications to estrogen treatment, including those who are immediately postpartum, have thalassemia, sickle-cell disease, gallbladder disease, or currently experiencing thrombo-embolic disorders, valvular heart disease, ischemic heart disease.\n\nIntrauterine, injectable methods and contraceptive implants named as long-acting reversible contraceptives (LARC) are the more efficient reversible contraceptive approaches are highly effective, longer-acting contraceptive methods levels."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Among patients attending Tanta University Hospitals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 80 healthy fertile females\n* 20-35 years\n* With normal menstrual history\n* Had at least one offspring after spontaneous pregnancy\n\nExclusion Criteria:\n\n* Any disease affects uterus (uterine tumors fibroids, endometriosis, prolapse, or tuberculosis).\n* Ovarian tumors\n* submucous myoma\n* irregular menstrual cycle\n* past or family history of breast disease\n* Diabetic patients,\n* medication affecting reproductive or metabolic functions.\n* endometrial thickness \\<7 mm on the secretory transformation day\n* history of spontaneous abortions\n* history of embryo transfer failure on over three occasions\n* Patients had cortisol medications\n* patients who received radiological treatment'}, 'identificationModule': {'nctId': 'NCT05742503', 'briefTitle': 'Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effects of Different Progesterone Containing Contraceptive Methods on Safety and Endogenous Progesterone Level', 'orgStudyIdInfo': {'id': '36035/11/22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Depo-Provera group', 'description': 'This group will receive150 mg of injectable progesterone every 90 days or 3 months', 'interventionNames': ['Other: Depo-Provera']}, {'label': 'Implanon group', 'description': 'This group will receive 68 mg of etonogestrel implant formerly known as Implanon.', 'interventionNames': ['Other: Implanon']}, {'label': 'Norgestrel group', 'description': 'This group will receive 0.075 mg of norgestrel (Ovrette®) once daily.', 'interventionNames': ['Other: Norgestrel']}, {'label': 'Mirena group', 'description': 'This group will receive IUD (Mirena) containing 52 mg of levonorgestrel.', 'interventionNames': ['Other: Mirena']}], 'interventions': [{'name': 'Depo-Provera', 'type': 'OTHER', 'description': 'Injectable progesterone', 'armGroupLabels': ['Depo-Provera group']}, {'name': 'Implanon', 'type': 'OTHER', 'description': 'Etonogestrel implant', 'armGroupLabels': ['Implanon group']}, {'name': 'Norgestrel', 'type': 'OTHER', 'description': 'Pill containing progesterone', 'armGroupLabels': ['Norgestrel group']}, {'name': 'Mirena', 'type': 'OTHER', 'description': 'Levonorgestrel-releasing intra-uterine drug (IUD)', 'armGroupLabels': ['Mirena group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Ahmed Ossman', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Mona K Omar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Obstetrics and Gynecology Department, Faculty of Medicine,Tanta University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'One year', 'ipdSharing': 'YES', 'description': 'The data will be available upon reasonable request from the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Obstetrics and Gynecology Department,Faculty of Medicine,Tanta University', 'investigatorFullName': 'Ahmed Ossman', 'investigatorAffiliation': 'Tanta University'}}}}