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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

Page last updated: August 23, 2015

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