Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-30 @ 3:14 PM
Study NCT ID:
NCT00128934
Status:
COMPLETED
Last Update Posted:
2007-12-27
First Post:
2005-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D011293', 'term': 'Premenstrual Syndrome'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019304', 'term': 'Ethinyl Estradiol-Norgestrel Combination'}], 'ancestors': [{'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 744}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-18', 'studyFirstSubmitDate': '2005-08-08', 'studyFirstSubmitQcDate': '2005-08-08', 'lastUpdatePostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle'}]}, 'conditionsModule': {'keywords': ['Premenstrual Syndrome (PMS)', 'Hormone Therapy'], 'conditions': ['Menstruation Disturbances', 'Premenstrual Syndrome']}, 'referencesModule': {'references': [{'pmid': '22067793', 'type': 'DERIVED', 'citation': 'Halbreich U, Freeman EW, Rapkin AJ, Cohen LS, Grubb GS, Bergeron R, Smith L, Mirkin S, Constantine GD. Continuous oral levonorgestrel/ethinyl estradiol for treating premenstrual dysphoric disorder. Contraception. 2012 Jan;85(1):19-27. doi: 10.1016/j.contraception.2011.05.008. Epub 2011 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy, women aged 18 to 49 years.\n* History of severe PMS symptoms over the last year, as determined by the investigator.\n* Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.\n\nExclusion Criteria:\n\n* Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years.\n* Contraindication to combination oral contraceptives.\n* Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.\n\nOther exclusions apply.'}, 'identificationModule': {'nctId': 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