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

NCT00161681

Last updated date
Study Location
Huntsville, Alabama, 35801, 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.
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

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


- 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.

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Premenstrual SyndromeStudy Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
NCT00161681
  1. Huntsville, Alabama
  2. Peoria, Arizona
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Tucson, Arizona
  6. San Diego, California
  7. Denver, Colorado
  8. Longmont, Colorado
  9. Aventura, Florida
  10. Boynton Beach, Florida
  11. Clearwater, Florida
  12. Deland, Florida
  13. Fort Myers, Florida
  14. Miami, Florida
  15. Miami, Florida
  16. Pembroke Pines, Florida
  17. Tampa, Florida
  18. West Palm Beach, Florida
  19. Atlanta, Georgia
  20. Atlanta, Georgia
  21. Savannah, Georgia
  22. Idaho Falls, Idaho
  23. Chicago, Illinois
  24. Chicago, Illinois
  25. Lexington, Kentucky
  26. Kansas City, Missouri
  27. Las Vegas, Nevada
  28. Las Vegas, Nevada
  29. Moorestown, New Jersey
  30. Rochester, New York
  31. Fayetteville, North Carolina
  32. Winston-Salem, North Carolina
  33. Cleveland, Ohio
  34. Mogadore, Ohio
  35. Eugene, Oregon
  36. Medford, Oregon
  37. Philadelphia, Pennsylvania
  38. Pittsburgh, Pennsylvania
  39. Wexford, Pennsylvania
  40. Hilton Head Island, South Carolina
  41. Mt. Pleasant, South Carolina
  42. Nashville, Tennessee
  43. Houston, Texas
  44. San Antonio, Texas
  45. Sandy, Utah
  46. Richmond, Virginia
  47. Lakewood, Washington
  48. Seattle, Washington
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.
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 Premenstrual Syndrome
Intervention  ICMJE Drug: Levonorgestrel/Ethinyl Estradiol
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Enrollment  ICMJE
 (submitted: September 7, 2005)
200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161681
Other Study ID Numbers  ICMJE 0858A2-322
B3121024 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
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 May 2007

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