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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel/Ethinyl Estradiol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle |
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Inclusion Criteria:
Exclusion Criteria:
Other exclusion applies.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | Argentina | |||||
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| Córdoba |
| Argentina |
| Rosario-Santa Fe | Argentina |
| Curitiba | Brazil |
| Goiânia | Brazil |
| Porto Alegre | Brazil |
| Salvador | Brazil |
| São Paulo | Brazil |
| Sorocaba | Brazil |
| Santiago | Chile |
| Temuco | Chile |
| Aarhus | Denmark |
| Frederiksberg | Denmark |
| København NV | Denmark |
| Rungsted Kyst | Denmark |
| Helsinki | Finland |
| Kuopio | Finland |
| Oulu | Finland |
| Turku | Finland |
| Berlin | Germany |
| Bonn | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Lomas de Virreyes | D.F. | Mexico |
| Guadalajara | Jalisco | Mexico |
| Zapopan | Jalisco | Mexico |
| Monterrey | N.L. | Mexico |
| San Luis Potosí City | San Luis Potosí | Mexico |
| Mexico City | Mexico |
| Amsterdam | Netherlands |
| Apeldoorn | Netherlands |
| Den Helder | Netherlands |
| Enschede | Netherlands |
| Nieuwegein | Netherlands |
| Bialystok | Poland |
| Gdansk | Poland |
| Mysłowice | Poland |
| Poznan | Poland |
| Warsaw | Poland |
| S | Bucharest | Romania |
| Cluj-Napoca | Romania |
| Iași | Romania |
| Gothenburg | Sweden |
| Stockholm | Sweden |
| Umeå | Sweden |
| Uppsala | Sweden |
| Conwell | United Kingdom |
| Fowey | United Kingdom |
| London | United Kingdom |
| Plymouth | United Kingdom |
| St Austell | United Kingdom |
| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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