Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
NCT ID: NCT00195559
Last Updated: 2007-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
526 participants
INTERVENTIONAL
2005-09-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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Levonorgestrel/Ethinyl Estradiol
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Contraindication to combination oral contraceptives.
* Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
Other exclusion applies.
18 Years
49 Years
FEMALE
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Principal Investigators
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Locations
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Buenos Aires, , Argentina
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
Countries
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Other Identifiers
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0858A4-318
Identifier Type: -
Identifier Source: org_study_id