Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-04 @ 4:43 AM
Study NCT ID:
NCT00195559
Status:
COMPLETED
Last Update Posted:
2007-12-27
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011293', 'term': 'Premenstrual Syndrome'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}], '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': 526}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-18', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-15', 'lastUpdatePostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', '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': ['Premenstrual Syndrome', 'Menstruation Disturbances']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.'}, '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 exclusion applies.'}, 'identificationModule': {'nctId': 'NCT00195559', 'briefTitle': 'Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder', 'orgStudyIdInfo': {'id': '0858A4-318'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Levonorgestrel/Ethinyl Estradiol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Córdoba', 'country': 'Argentina', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Rosario-Santa Fe', 'country': 'Argentina'}, {'city': 'Curitiba', 'country': 'Brazil', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Goiânia', 'country': 'Brazil', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'city': 'Porto Alegre', 'country': 'Brazil', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Salvador', 'country': 'Brazil', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'city': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Sorocaba', 'country': 'Brazil', 'geoPoint': {'lat': -23.50167, 'lon': -47.45806}}, {'city': 'Santiago', 'country': 'Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Temuco', 'country': 'Chile', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'city': 'Aarhus', 'country': 'Denmark', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Frederiksberg', 'country': 'Denmark', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}, {'city': 'København NV', 'country': 'Denmark', 'geoPoint': {'lat': 55.71258, 'lon': 12.52343}}, {'city': 'Rungsted Kyst', 'country': 'Denmark', 'geoPoint': {'lat': 55.88547, 'lon': 12.53034}}, {'city': 'Helsinki', 'country': 'Finland', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Kuopio', 'country': 'Finland', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Oulu', 'country': 'Finland', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Turku', 'country': 'Finland', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Lomas de Virreyes', 'state': 'D.F.', 'country': 'Mexico'}, {'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'Zapopan', 'state': 'Jalisco', 'country': 'Mexico', 'geoPoint': {'lat': 20.72111, 'lon': -103.38742}}, {'city': 'Monterrey', 'state': 'N.L.', 'country': 'Mexico', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'city': 'San Luis Potosí City', 'state': 'San Luis Potosí', 'country': 'Mexico', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'city': 'Mexico City', 'country': 'Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Apeldoorn', 'country': 'Netherlands', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'city': 'Den Helder', 'country': 'Netherlands', 'geoPoint': {'lat': 52.95988, 'lon': 4.75933}}, {'city': 'Enschede', 'country': 'Netherlands', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Gdansk', 'country': 'Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Mysłowice', 'country': 'Poland', 'geoPoint': {'lat': 50.20745, 'lon': 19.16668}}, {'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'S', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Iași', 'country': 'Romania', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Gothenburg', 'country': 'Sweden', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Umeå', 'country': 'Sweden', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'city': 'Uppsala', 'country': 'Sweden', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Conwell', 'country': 'United Kingdom'}, {'city': 'Fowey', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.33634, 'lon': -4.6386}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'St Austell', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.3425, 'lon': -4.77442}}], 'overallOfficials': [{'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Argentina, Chile, scheima@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Brazil, xavierl@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Denmark, Finland, Sweden, MedInfoNord@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Germany, MedinfoDEU@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Mexico, gomezlj@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Netherlands, trials-NL@wyeth.com'}, {'name': 'Trial Managersp', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Poland, WPWZMED@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Romania, WPVIMED@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For UK, ukmedinfo@wyeth.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}