Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT04676061
Status:
TERMINATED
Last Update Posted:
2024-02-02
First Post:
2020-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077563', 'term': 'Norethindrone Acetate'}], 'ancestors': [{'id': 'D009640', 'term': 'Norethindrone'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'whyStopped': 'It was in the best interest of the investigator to terminate the study earlier than anticipated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days of bleeding and spotting', 'timeFrame': '30 days', 'description': 'To evaluate days of bleeding and spotting within 90-day intervals by quantifying a self-perception of amount of bleeding on a scale of 0 to 4 and associated symptoms on a scale of 0 to 10 using the Daily Dairy of Symptoms'}], 'secondaryOutcomes': [{'measure': 'Quality of life measurements', 'timeFrame': '30 days', 'description': "To evaluate quality of life by comparing the treatment and placebo groups' associated symptoms on a scale of 0 to 10 using the Daily Diary of Symptoms."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uterine Hemorrhage', 'Norethindrone Acetate', 'Contraceptives'], 'conditions': ['Birth Control', 'Contraception', 'Implant', 'Breakthrough Bleeding', 'Uterine Bleeding']}, 'descriptionModule': {'briefSummary': 'Effects of norethindrone acetate (NTA) in patients with Nexplanon.', 'detailedDescription': 'The purpose of this study is to find out what effects norethindrone acetate (NTA) has on the duration and recurrence of frequent and/or prolonged bleeding associated with Nexplanon™.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '48 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18-48\n* Between ages of 14-17 with parental/guardian permission\n* Women desiring placement of Nexplanon™\n* Willing to keep a daily symptom calendar\n* Keep appointments\n* Women not desiring to become pregnant in the next 2 years\n\nExclusion Criteria:\n\n* Known or suspected Pregnancy\n* Less than 8weeks postpartum\n* Menarche less than two years ago\n* Current or past history of thrombosis or thromboembolic disorders\n* Hepatic tumors (benign or malignant)\n* Active liver disease\n* Undiagnosed abnormal genital bleeding\n* Undiagnosed headaches\n* Known or suspected carcinoma of the breast or personal history of breast cancer\n* Hypersensitivity to any of the components in Nexplanon™\n* BMI greater than 40\n* Depomedroxyprogesterone acetate injection in the previous 12 weeks'}, 'identificationModule': {'nctId': 'NCT04676061', 'briefTitle': 'Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™; a Randomized Double-Blinded Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '020-291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Placebo to Norethindrone acetate (NTA)', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Group', 'description': 'Norethindrone acetate (NTA)', 'interventionNames': ['Drug: Norethindrone acetate (NTA)']}], 'interventions': [{'name': 'Norethindrone acetate (NTA)', 'type': 'DRUG', 'description': 'norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks', 'armGroupLabels': ['Treatment Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76502', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Research Institute', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}], 'overallOfficials': [{'name': 'Joanna Stacey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor Reserach Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}