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Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS - Article


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Drospirenone and Ethinyl Estradiol

drospirenone 3.0mg and ethinyl estradiol 0.030mg; Yasmin


Clinical Trial: Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS

This study is currently recruiting patients.
Verified by Wyeth September 2005

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00161681

Purpose

The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.
Condition Intervention Phase
Premenstrual Syndrome
  Drug: Levonorgestrel/Ethinyl Estradiol
 Phase III

MedlinePlus related topics:  Premenstrual Syndrome

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

Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symptoms

Further Study Details: 
Primary Outcomes: To evaluate the efficacy of a continuous-use oral contraceptive regimen containing a combination of LNG/EE in preventing moderate to severe menstrual cycle-related symptoms compared with placebo.
Secondary Outcomes: To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction.
Expected Total Enrollment:  200

Study start: August 2005

Eligibility

Ages Eligible for Study:  18 Years   -   49 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

  • Healthy women aged 18 to 49 years
  • Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1
  • History of menstrual cycle related symptoms as determined by the investigator.

Exclusion Criteria:

  • Contraindication to combination oral contraceptives
  • Depression requiring hospitalization or associated with suicidal ideation within the last 3 years
  • Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00161681

Trial Manager       clinicaltrialinfo@wyeth.com

Alabama
      Huntsville,  Alabama,  35801,  United States; Not yet recruiting
see Central Contact

Arizona
      Tucson,  Arizona,  85715,  United States; Not yet recruiting
see Central Contact

      Phoenix,  Arizona,  85031,  United States; Not yet recruiting
see Central Contact

      Phoenix,  Arizona,  85032,  United States; Recruiting
see Central Contact

      Peoria,  Arizona,  85381,  United States; Not yet recruiting
see Central Contact

California
      San Diego,  California,  92103,  United States; Not yet recruiting
see Central Contact

Colorado
      Longmont,  Colorado,  80501,  United States; Recruiting
see Central Contact

      Denver,  Colorado,  80202,  United States; Recruiting
see Central Contact

Florida
      Boynton Beach,  Florida,  33437,  United States; Not yet recruiting
see Central Contact

      Miami,  Florida,  33143,  United States; Not yet recruiting
see Central Contact

      Miami,  Florida,  33186,  United States; Recruiting
see Central Contact

      Aventura,  Florida,  33180,  United States; Not yet recruiting
see Central Contact

      West Palm Beach,  Florida,  33407,  United States; Recruiting
see Central Contact

      Pembroke Pines,  Florida,  33024,  United States; Not yet recruiting
see Central Contact

      Deland,  Florida,  32720,  United States; Not yet recruiting
see Central Contact

      Clearwater,  Florida,  33761,  United States; Not yet recruiting
see Central Contact

      Tampa,  Florida,  33607,  United States; Not yet recruiting
see Central Contact

      Fort Myers,  Florida,  33916,  United States; Not yet recruiting
see Central Contact

Georgia
      Atlanta,  Georgia,  30328,  United States; Not yet recruiting
see Central Contact

      Atlanta,  Georgia,  30342,  United States; Not yet recruiting
see Central Contact

      Savannah,  Georgia,  31406,  United States; Recruiting
see Central Contact

Idaho
      Idaho Falls,  Idaho,  83404,  United States; Recruiting
see Central Contact

Illinois
      Chicago,  Illinois,  60631,  United States; Not yet recruiting
see Central Contact

      Chicago,  Illinois,  60612,  United States; Recruiting
see Central Contact

Kentucky
      Lexington,  Kentucky,  40509,  United States; Recruiting
see Central Contact

Missouri
      Kansas City,  Missouri,  64114,  United States; Not yet recruiting
see Central Contact

Nevada
      Las Vegas,  Nevada,  89109,  United States; Recruiting
see Central Contact

      Las Vegas,  Nevada,  89118,  United States; Recruiting
see Central Contact

New Jersey
      Moorestown,  New Jersey,  08057,  United States; Not yet recruiting
see Central Contact

New York
      Rochester,  New York,  14609,  United States; Not yet recruiting
see Central Contact

North Carolina
      Fayetteville,  North Carolina,  28304,  United States; Not yet recruiting
see Central Contact

      Winston Salem,  North Carolina,  27103,  United States; Not yet recruiting
see Central Contact

      Winston Salem,  North Carolina,  27103,  United States; Recruiting
see Central Contact

Ohio
      Mogadore,  Ohio,  44260,  United States; Not yet recruiting
see Central Contact

      Cleveland,  Ohio,  44122,  United States; Recruiting
see Central Contact

Oregon
      Eugene,  Oregon,  97401,  United States; Not yet recruiting
see Central Contact

      Medford,  Oregon,  97504,  United States; Not yet recruiting
see Central Contact

Pennsylvania
      Pittsburgh,  Pennsylvania,  15206,  United States; Not yet recruiting
see Central Contact

      Wexford,  Pennsylvania,  15090,  United States; Not yet recruiting
see Central Contact

      Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
see Central Contact

South Carolina
      Hilton Head Island,  South Carolina,  29926,  United States; Recruiting
see Central Contact

      Mt. Pleasant,  South Carolina,  29464,  United States; Not yet recruiting
see Central Contact

Tennessee
      Nashville,  Tennessee,  37203,  United States; Not yet recruiting
see Central Contact

Texas
      Houston,  Texas,  77024,  United States; Not yet recruiting
see Central Contact

      San Antonio,  Texas,  78229,  United States; Not yet recruiting
see Central Contact

Utah
      Sandy,  Utah,  84070,  United States; Not yet recruiting
see Central Contact

Virginia
      Richmond,  Virginia,  23226,  United States; Not yet recruiting
see Central Contact

Washington
      Seattle,  Washington,  98105,  United States; Not yet recruiting
see Central Contact

      Lakewood,  Washington,  98499,  United States; Not yet recruiting
see Central Contact

Study chairs or principal investigators

Medical Monitor, MD,  Study Director,  Wyeth Research   

More Information

Study ID Numbers:  0858A2-322
Last Updated:  September 11, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00161681
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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Page Updated: September 6, 2005
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