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


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Ethinyl Estradiol and Norethindrone (Oral Contraceptive)

Brevicon; Estrostep 21; Estrostep Fe; Gencept 0.5/35; Gencept 1/35; Gencept 10/11; Genora 0.5/35; Genora 1/35; Jenest-28; Loestrin 21 1.5/30; Loestrin 21 1/20; Loestrin Fe 1.5/30; Loestrin Fe 1/20; Microgestin Fe 1.5/30; Microgestin Fe 1/20; Modicon; N. E. E.; Necon 0.5/35; Necon 1/35; Necon 10/11; Necon 7/7/7; Nelova 0.5/35 E; Nelova 1/35 E; Nelova 10/11; Norcept-E 1/35; Norethin 1/35 E; Norinyl 1+35; Nortrel 0.5/35; Nortrel 1/35; Nortrel 7/7/7; Ortho-Novum 1/35; Ortho-Novum 10/11; Ortho-Novum 7/7/7; Ovcon-35; Ovcon-50; Tri-Norinyl 



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

This study is not yet open for patient recruitment.
Verified by Wyeth September 2005

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00195559

Purpose

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.
Condition Intervention Phase
Premenstrual Syndrome
Menstruation Disturbances
  Drug: Levonorgestrel/Ethinyl Estradiol
 Phase III

MedlinePlus related topics:  Menstruation;   Premenstrual Syndrome

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary Outcomes: Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
Expected Total Enrollment:  526

Study start: September 2005

Eligibility

Ages Eligible for Study:  18 Years   -   49 Years,  Genders Eligible for Study:  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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00195559

Trial Manager       clinicaltrialinfo@wyeth.com

Argentina
      Buenos Aires,  Argentina
see Central Contact

      Ciudad Autonoma de Buenos Aires,  Argentina
see Central Contact

      Rosario - Santa Fe,  Argentina
see Central Contact

      Buenos Aires,  Argentina
see Central Contact

      Cordoba,  Argentina
see Central Contact

Brazil
      Sao Paulo,  Brazil
see Central Contact

      Sorocaba,  Brazil
see Central Contact

      Salvador,  Brazil
see Central Contact

      Porto Alegre,  Brazil
see Central Contact

      Curitiba,  Brazil
see Central Contact

      Goiania,  Brazil
see Central Contact

Chile
      Santiago,  Chile
see Central Contact

      Temuco,  Chile
see Central Contact

Denmark
      Kobenhavn NV,  Denmark
see Central Contact

      Arhus,  Denmark
see Central Contact

      Rungsted Kyst,  Denmark
see Central Contact

      Frederiksberg,  Denmark
see Central Contact

Finland
      Helsinki,  Finland
see Central Contact

      Oulu,  Finland
see Central Contact

      Kuopio,  Finland
see Central Contact

      Turku,  Finland
see Central Contact

Germany
      Berlin,  Germany
see Central Contact

      Hannover,  Germany
see Central Contact

      Bonn,  Germany
see Central Contact

      Hamburg,  Germany
see Central Contact

Mexico
      Mexico City,  Mexico
see Central Contact

Mexico, D.F.
      Lomas de Virreyes,  D.F.,  Mexico
see Central Contact

Mexico, Jalisco
      Zapopan,  Jalisco,  Mexico
see Central Contact

      Guadalajara,  Jalisco,  Mexico
see Central Contact

Mexico, N.L.
      Monterrey,  N.L.,  Mexico
see Central Contact

Mexico, SLP
      San Luis Potosi,  SLP,  Mexico
see Central Contact

Netherlands
      Den Helder,  Netherlands
see Central Contact

      Nieuwegein,  Netherlands
see Central Contact

      Apeldoorn,  Netherlands
see Central Contact

      ENSCHEDE,  Netherlands
see Central Contact

      Amsterdam,  Netherlands
see Central Contact

Poland
      Poznan,  Poland
see Central Contact

      Gdansk,  Poland
see Central Contact

      Myslowice,  Poland
see Central Contact

      Warszawa,  Poland
see Central Contact

      Bialystok,  Poland
see Central Contact

Romania
      Iasi,  Romania
see Central Contact

      Bucuresti,  Romania
see Central Contact

      Cluj Napoca,  Romania
see Central Contact

Sweden
      Stockholm,  Sweden
see Central Contact

      Umea,  Sweden
see Central Contact

      Uppsala,  Sweden
see Central Contact

      Goteborg,  Sweden
see Central Contact

United Kingdom
      London,  United Kingdom
see Central Contact

      Fowey,  United Kingdom
see Central Contact

      St. Austell,  United Kingdom
see Central Contact

      Plymouth,  United Kingdom
see Central Contact

      Conwell,  United Kingdom
see Central Contact

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   

More Information

Study ID Numbers:  0858A4-318
Last Updated:  September 19, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00195559
Health Authority: Poland: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-20


Source: ClinicalTrials.gov
Cache Date: September 21, 2005

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Page Updated: June 1, 2005
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