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| Sponsor: | Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00195559 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Premenstrual Syndrome Menstruation Disturbances |
Drug: Levonorgestrel/Ethinyl Estradiol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 526 |
| Study Start Date: | September 2005 |
| Study Completion Date: | December 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other exclusion applies.
Contacts and Locations
Hide Study Locations| Argentina | |
| Buenos Aires, Argentina | |
| Ciudad Autonoma de Buenos Aires, Argentina | |
| Rosario-Santa Fe, Argentina | |
| Cordoba, Argentina | |
| Brazil | |
| Sao Paulo, Brazil | |
| Sorocaba, Brazil | |
| Salvador, Brazil | |
| Porto Alegre, Brazil | |
| Curitiba, Brazil | |
| Goiania, Brazil | |
| Chile | |
| Santiago, Chile | |
| Temuco, Chile | |
| Denmark | |
| Kobenhavn NV, Denmark | |
| Arhus, Denmark | |
| Rungsted Kyst, Denmark | |
| Frederiksberg, Denmark | |
| Finland | |
| Helsinki, Finland | |
| Turku, Finland | |
| Kuopio, Finland | |
| Oulu, Finland | |
| Germany | |
| Berlin, Germany | |
| Hannover, Germany | |
| Bonn, Germany | |
| Hamburg, Germany | |
| Mexico | |
| Mexico City, Mexico | |
| Mexico, D.F. | |
| Lomas de Virreyes, D.F., Mexico | |
| Mexico, Jalisco | |
| Zapopan, Jalisco, Mexico | |
| Guadalajara, Jalisco, Mexico | |
| Mexico, N.L. | |
| Monterrey, N.L., Mexico | |
| Mexico, SLP | |
| San Luis Potosi, SLP, Mexico | |
| Netherlands | |
| Apeldoorn, Netherlands | |
| Nieuwegein, Netherlands | |
| Den Helder, Netherlands | |
| Enschede, Netherlands | |
| Amsterdam, Netherlands | |
| Poland | |
| Poznan, Poland | |
| Gdansk, Poland | |
| Myslowice, Poland | |
| Warszawa, Poland | |
| Bialystok, Poland | |
| Romania | |
| Iasi, Romania | |
| S | |
| Bucuresti, Romania | |
| Cluj-Napoca, Romania | |
| Sweden | |
| Uppsala, Sweden | |
| Umea, Sweden | |
| Stockholm, Sweden | |
| Goteborg, Sweden | |
| United Kingdom | |
| London, United Kingdom | |
| Fowey, United Kingdom | |
| St. Austell, United Kingdom | |
| Plymouth, United Kingdom | |
| Conwell, United Kingdom | |
| Principal Investigator: | Trial Manager | For Argentina, Chile, scheima@wyeth.com |
| Principal Investigator: | Trial Manager | For Brazil, xavierl@wyeth.com |
| Principal Investigator: | Trial Manager | For Denmark, Finland, Sweden, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For Germany, MedinfoDEU@wyeth.com |
| Principal Investigator: | Trial Manager | For Mexico, gomezlj@wyeth.com |
| Principal Investigator: | Trial Manager | For Netherlands, trials-NL@wyeth.com |
| Principal Investigator: | Trial Managersp | For Poland, WPWZMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Romania, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For UK, ukmedinfo@wyeth.com |
More Information
| Study ID Numbers: | 0858A4-318 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 18, 2007 |
| ClinicalTrials.gov Identifier: | NCT00195559 History of Changes |
| Health Authority: | Poland: Ministry of Health |
|
Premenstrual Syndrome (PMS) Hormone Therapy |
|
Contraceptive Agents Contraceptives, Oral Estradiol valerate Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Estradiol 17 beta-cypionate Reproductive Control Agents Hormones Pathologic Processes Menstruation Disturbances Mental Disorders Estradiol 3-benzoate |
Syndrome Levonorgestrel Therapeutic Uses Contraceptives, Oral, Synthetic Polyestradiol phosphate Estrogens Disease Ethinyl Estradiol Depressive Disorder Estradiol Pharmacologic Actions Mood Disorders Premenstrual Syndrome |
