Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder

NCT00128934

Last updated date
Study Location
Scottsdale, Arizona, 85251, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Menstruation Disturbances, Premenstrual Syndrome
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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 exclusions apply.

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Menstruation Disturbances, Premenstrual SyndromeStudy Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
NCT00128934
  1. Scottsdale, Arizona
  2. Tucson, Arizona
  3. Jonesboro, Arkansas
  4. Little Rock, Arkansas
  5. Carmichael, California
  6. Los Angeles, California
  7. San Diego, California
  8. Denver, Colorado
  9. Lakewood, Colorado
  10. Longmont, Colorado
  11. Middletown, Connecticut
  12. New Haven, Connecticut
  13. Waterbury, Connecticut
  14. Washington, District of Columbia
  15. Adventure, Florida
  16. Clearwater, Florida
  17. Fort Myers, Florida
  18. Hialeah, Florida
  19. Pembroke Pines, Florida
  20. West Palm Beach, Florida
  21. Atlanta, Georgia
  22. Atlanta, Georgia
  23. Savannah, Georgia
  24. Boise, Idaho
  25. Chicago, Illinois
  26. Chicago, Illinois
  27. Evansville, Indiana
  28. South Bend, Indiana
  29. Lexington, Kentucky
  30. New Orleans, Louisiana
  31. Glen Burnie, Maryland
  32. Boston, Massachusetts
  33. Pittsfield, Massachusetts
  34. Springfield, Massachusetts
  35. Brooklyn, New York
  36. Buffalo, New York
  37. New York City, New York
  38. Rochester, New York
  39. Fayetteville, North Carolina
  40. New Bern, North Carolina
  41. Winston-Salem, North Carolina
  42. Cincinnati, Ohio
  43. Cleveland, Ohio
  44. Mogadore, Ohio
  45. Oklahoma City, Oklahoma
  46. Tulsa, Oklahoma
  47. Eugene, Oregon
  48. Medford, Oregon
  49. Philadelphia, Pennsylvania
  50. Philadelphia, Pennsylvania
  51. Wexford, Pennsylvania
  52. East Providence, Rhode Island
  53. Greer, South Carolina
  54. Hilton Head Island, South Carolina
  55. Nashville, Tennessee
  56. Austin, Texas
  57. Carrollton, Texas
  58. Conroe, Texas
  59. San Antonio, Texas
  60. Salt Lake City, Utah
  61. Sandy, Utah
  62. Burlington, Vermont
  63. Charlottesville, Virginia
  64. Norfolk, Virginia
  65. Richmond, Virginia
  66. Richmond, Virginia
  67. Richmond, Virginia
  68. Lakewood, Washington
  69. Renton, Washington
  70. Edmonton, Alberta
  71. Edmonton, Alberta
  72. Kelowna, British Columbia
  73. Vancouver, British Columbia
  74. Hamilton, Ontario
  75. Toronto, Ontario
  76. Hull, Quebec
  77. Montréal, Quebec
  78. Montréal, Quebec
  79. Pointe-Claire, Quebec
  80. Quebec City, Quebec
  81. Quebec City, Quebec
  82. Shawinigan, Quebec
  83. Sherbrooke, Quebec
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder
Brief Summary The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Menstruation Disturbances
  • Premenstrual Syndrome
Intervention  ICMJE Drug: levonorgestrel/ethinyl estradiol
Study Arms  ICMJE Not Provided
Publications * Halbreich U, Freeman EW, Rapkin AJ, Cohen LS, Grubb GS, Bergeron R, Smith L, Mirkin S, Constantine GD. Continuous oral levonorgestrel/ethinyl estradiol for treating premenstrual dysphoric disorder. Contraception. 2012 Jan;85(1):19-27. doi: 10.1016/j.contraception.2011.05.008. Epub 2011 Jul 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 8, 2005)
744
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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 exclusions apply.

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00128934
Other Study ID Numbers  ICMJE 0858A4-316
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP