Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT03594604
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2018-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Norethindrone for the Delay of Menstruation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009640', 'term': 'Norethindrone'}, {'id': 'D000077563', 'term': 'Norethindrone Acetate'}, {'id': 'D003276', 'term': 'Contraceptives, Oral'}, {'id': 'D003277', 'term': 'Contraceptives, Oral, Combined'}], 'ancestors': [{'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'}, {'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Patients will be randomized to receive oral contraceptive pills or norethindrone'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to receive oral contraceptive pills or norethindrone'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2007-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-18', 'studyFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2018-07-18', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'breakthrough bleeding on treatment', 'timeFrame': 'at 2 weeks from starting therapy', 'description': 'comparison of breakthrough bleeding between oral contraceptives and norethindrone'}], 'secondaryOutcomes': [{'measure': 'Likelihood of recommending this method or using it again', 'timeFrame': 'at 2 weeks from starting therapty', 'description': 'A questionnaire given to the patient at 2 weeks from starting therapy and containing the question "on a scale from 1-5 (5 most likely) how likely are you to recommend this method to a friend or using it again yourself".'}, {'measure': 'Adverse effects', 'timeFrame': 'at 2 weeks from starting therapy', 'description': 'measurement of side effects from norethindrone therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['norethindrone'], 'conditions': ['Menstrual Flow Altered']}, 'referencesModule': {'references': [{'pmid': '23990713', 'type': 'BACKGROUND', 'citation': 'Attia AM, Ibrahim MM, Abou-Setta AM. Role of the levonorgestrel intrauterine system in effective contraception. Patient Prefer Adherence. 2013 Aug 9;7:777-85. doi: 10.2147/PPA.S36948. eCollection 2013.'}, {'pmid': '17074351', 'type': 'RESULT', 'citation': 'Yairi-Oron Y, Rabinson J, Orvieto R. A simplified approach to religious infertility. Fertil Steril. 2006 Dec;86(6):1771-2. doi: 10.1016/j.fertnstert.2006.05.050. Epub 2006 Oct 30.'}, {'pmid': '15729953', 'type': 'RESULT', 'citation': 'Chertok IR, Zimmerman DR, Taragin S, Silverman Z, Hallak M. Implications of endometriosis for women who observe Jewish law (halakha). Isr Med Assoc J. 2005 Feb;7(2):71-4.'}, {'pmid': '19666684', 'type': 'RESULT', 'citation': 'Amy JJ, Tripathi V. Contraception for women: an evidence based overview. BMJ. 2009 Aug 7;339:b2895. doi: 10.1136/bmj.b2895. No abstract available.'}, {'pmid': '31138184', 'type': 'DERIVED', 'citation': 'Dean J, Kramer KJ, Akbary F, Wade S, Huttemann M, Berman JM, Recanati MA. Norethindrone is superior to combined oral contraceptive pills in short-term delay of menses and onset of breakthrough bleeding: a randomized trial. BMC Womens Health. 2019 May 28;19(1):70. doi: 10.1186/s12905-019-0766-6.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of oral contraceptive pills versus norethindrone to delay menstuation.', 'detailedDescription': 'Many women ask the OBGYN for help in delaying a poorly timed period in order to participate in events that menstruation would normally interfere with. While most OBGYNs prescribe combined oral contraceptives for this purpose, this method often results in unpredictable spotting, especially at the beginning of therapy. Norethindrone, a progesterone agonist, inhibits ovulation through its antagonistic effect at the anterior pituitary, preventing the release of LH. Additionally, it thickens cervical mucus to inhibit sperm migration into the uterine cavity . Norethindrone downregulates estrogen receptors on the endometrium lining preventing endometrial proliferation, enhancing glandular secretion, and maintaining endometrium integrity. Therefore, norethindrone is well suited in preventing the endometrium from breakdown and preventing menstrual bleeding. Indeed, many OBGYNs have consistently used it for this purpose in women who desire to remain fertile. The intention of our study was to compare norethindrone to birth control pills in order to determine the effectiveness at suppressing bleeding and spotting, compare side effect profiles and to find a method allowing women to freely and comfortably participate in their life events.\n\nOBJECTIVES:\n\n1. Determine if norethindrone can delay menstruation without breakthrough bleeding\n2. Compare norethindrone with oral contraceptive pills for delaying menstruation\n3. Compare patient satisfaction of each method\n4. Compare side effect profiles of each method'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only females menstruate', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female, age 18-45, regular periods, desires to postpone menstrual period,\n\nExclusion Criteria:\n\n* fibroids, irregular menstrual cycle, endometrial polyps, BMI\\>30'}, 'identificationModule': {'nctId': 'NCT03594604', 'briefTitle': 'Norethindrone for the Delay of Menstruation', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation', 'orgStudyIdInfo': {'id': '040818M1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Norethindrone', 'description': 'Delaying menstruation using Norethindrone 5mg three times daily in women who desire postponement of their period for social or personal reasons.', 'interventionNames': ['Drug: Norethindrone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Contraceptive Pills', 'description': 'Women who desire postponing their periods are typically treated with oral contraceptive pills, the current standard of care.', 'interventionNames': ['Drug: oral contraceptive pill']}], 'interventions': [{'name': 'Norethindrone', 'type': 'DRUG', 'otherNames': ['(Aygestin)'], 'description': 'Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.', 'armGroupLabels': ['Norethindrone']}, {'name': 'oral contraceptive pill', 'type': 'DRUG', 'otherNames': ['Combined oral contraceptive pill'], 'description': 'Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.', 'armGroupLabels': ['Oral Contraceptive Pills']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Maurice Recanati', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Vincents Catholic Medical Centers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Clinical Educator', 'investigatorFullName': 'Maurice-Andre Recanati', 'investigatorAffiliation': 'Wayne State University'}}}}