Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
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 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: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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
Rosario-Santa Fe, Argentina
Cordoba, Argentina
Sao Paulo, Brazil
Sorocaba, Brazil
Salvador, Brazil
Porto Alegre, Brazil
Curitiba, Brazil
Goiania, Brazil
Santiago, Chile
Temuco, Chile
Kobenhavn NV, Denmark
Arhus, Denmark
Rungsted Kyst, Denmark
Frederiksberg, Denmark
Helsinki, Finland
Oulu, Finland
Kuopio, Finland
Turku, Finland
Berlin, Germany
Hannover, Germany
Bonn, Germany
Hamburg, Germany
Mexico City, Mexico
Den Helder, Netherlands
Nieuwegein, Netherlands
Apeldoorn, Netherlands
Enschede, Netherlands
Amsterdam, Netherlands
Poznan, Poland
Gdansk, Poland
Myslowice, Poland
Warszawa, Poland
Bialystok, Poland
Iasi, Romania
S, Bucuresti, Romania
Cluj-Napoca, Romania
Stockholm, Sweden
Umea, Sweden
Uppsala, Sweden
Goteborg, Sweden
London, United Kingdom
Fowey, United Kingdom
St. Austell, United Kingdom
Plymouth, United Kingdom
Conwell, United Kingdom
Lomas de Virreyes, D.F., Mexico
Zapopan, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, N.L., Mexico
San Luis Potosi, SLP, Mexico
Additional Information
Starting date: September 2005
Ending date: December 2007
Last updated: December 18, 2007
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