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
CompletadoFase 3ClinicalTrials.gov
ID: NCT00195559Tipo: INTERVENTIONALInicio: 1 de sept de 2005Fin estimado: 1 de dic de 2007
Traducción no disponible, mostrando original
Resumen
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.
History of severe PMS symptoms over the last year, as determined by the investigator.
Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.
Criterios de exclusión
Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years.
Contraindication to combination oral contraceptives.
Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
Other exclusion applies.
Intervenciones
drug
Levonorgestrel/Ethinyl Estradiol
Ubicaciones
Buenos Aires, Argentina
Córdoba, Argentina
Rosario-Santa Fe, Argentina
Patrocinadores
PrincipalWyeth is now a wholly owned subsidiary of Pfizer
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