Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premenstrual Syndrome; Menstruation Disturbances
Intervention: Levonorgestrel/Ethinyl Estradiol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s): Trial Manager, Principal Investigator, Affiliation: For Argentina, Chile, scheima@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Brazil, xavierl@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Denmark, Finland, Sweden, MedInfoNord@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Germany, MedinfoDEU@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Mexico, gomezlj@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Netherlands, trials-NL@wyeth.com Trial Managersp, Principal Investigator, Affiliation: For Poland, WPWZMED@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Romania, WPVIMED@wyeth.com Trial Manager, Principal Investigator, Affiliation: For UK, ukmedinfo@wyeth.com
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Primary outcome: Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary outcome: Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Generally healthy, women aged 18 to 49 years.
- 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:
- 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.
Locations and Contacts
Buenos Aires, Argentina
Ciudad Autonoma de Buenos Aires, Argentina
Cordoba, Argentina
Rosario-Santa Fe, Argentina
Curitiba, Brazil
Goiania, Brazil
Porto Alegre, Brazil
Salvador, Brazil
Sao Paulo, Brazil
Sorocaba, Brazil
Santiago, Chile
Temuco, Chile
Arhus, Denmark
Frederiksberg, Denmark
Kobenhavn NV, Denmark
Rungsted Kyst, Denmark
Helsinki, Finland
Kuopio, Finland
Oulu, Finland
Turku, Finland
Berlin, Germany
Bonn, Germany
Hamburg, Germany
Hannover, Germany
Mexico City, Mexico
Amsterdam, Netherlands
Apeldoorn, Netherlands
Den Helder, Netherlands
Enschede, Netherlands
Nieuwegein, Netherlands
Bialystok, Poland
Gdansk, Poland
Myslowice, Poland
Poznan, Poland
Warszawa, Poland
S, Bucuresti, Romania
Cluj-Napoca, Romania
Iasi, Romania
Goteborg, Sweden
Stockholm, Sweden
Umea, Sweden
Uppsala, Sweden
Conwell, United Kingdom
Fowey, United Kingdom
London, United Kingdom
Plymouth, United Kingdom
St. Austell, United Kingdom
Lomas de Virreyes, D.f., Mexico
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Monterrey, N.l., Mexico
San Luis Potosi, SLP, Mexico
Additional Information
Starting date: September 2005
Last updated: December 18, 2007
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