Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

NCT00195559 | Completed Phase 3

• 1 other identifier: 0858A4-318
• Study Type: interventional
• Target: 526
• Locations: 12 countries
• Sites: 51

Brief 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.

Conditions

Premenstrual Syndrome; Menstruation Disturbances

Keywords

Premenstrual Syndrome (PMS); Hormone Therapy

Outcome Measures

Primary Outcomes (1)

• Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score

Secondary Outcomes (1)

• Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle

Interventions

Levonorgestrel/Ethinyl Estradiol DRUG

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (51)

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Buenos Aires, Argentina

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Córdoba, Argentina

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Rosario-Santa Fe, Argentina

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Curitiba, Brazil

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Goiânia, Brazil

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Porto Alegre, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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Sorocaba, Brazil

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Santiago, Chile

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Temuco, Chile

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Aarhus, Denmark

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Frederiksberg, Denmark

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København NV, Denmark

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Rungsted Kyst, Denmark

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Helsinki, Finland

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Kuopio, Finland

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Oulu, Finland

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Turku, Finland

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Berlin, Germany

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Bonn, Germany

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Hamburg, Germany

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Hanover, Germany

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Lomas de Virreyes, D.F., Mexico

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Guadalajara, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Monterrey, N.L., Mexico

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San Luis Potosí City, San Luis Potosí, Mexico

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Mexico City, Mexico

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Amsterdam, Netherlands

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Apeldoorn, Netherlands

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Den Helder, Netherlands

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Enschede, Netherlands

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Nieuwegein, Netherlands

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Bialystok, Poland

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Gdansk, Poland

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Mysłowice, Poland

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Poznan, Poland

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Warsaw, Poland

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Bucharest, Romania

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Cluj-Napoca, Romania

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Iași, Romania

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Gothenburg, Sweden

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Stockholm, Sweden

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Umeå, Sweden

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Uppsala, Sweden

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Conwell, United Kingdom

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Fowey, United Kingdom

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London, United Kingdom

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Plymouth, United Kingdom

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St Austell, United Kingdom

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MeSH Terms

Conditions

Premenstrual Syndrome; Menstruation Disturbances

Interventions

Ethinyl Estradiol-Norgestrel Combination

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: September 1, 2005
• Study Completion: December 1, 2007
• Last Updated: December 27, 2007

Record last verified: 2007-12

Locations

SE (4); GB (5); CL (2); ME (6); DE (4); PL (5); RO (3); NL (5); DK (4); BR (6); FI (4); AR (3)