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

NCT00195559

Last updated date
Study Location
Buenos Aires, , , Argentina
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, Menstruation Disturbances
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 exclusion applies.

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Premenstrual Syndrome, Menstruation DisturbancesStudy Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
NCT00195559
  1. Buenos Aires,
  2. Ciudad Autonoma de Buenos Aires,
  3. Cordoba,
  4. Rosario-Santa Fe,
  5. Curitiba,
  6. Goiania,
  7. Porto Alegre,
  8. Salvador,
  9. Sao Paulo,
  10. Sorocaba,
  11. Santiago,
  12. Temuco,
  13. Arhus,
  14. Frederiksberg,
  15. Kobenhavn NV,
  16. Rungsted Kyst,
  17. Helsinki,
  18. Kuopio,
  19. Oulu,
  20. Turku,
  21. Berlin,
  22. Bonn,
  23. Hamburg,
  24. Hannover,
  25. Lomas de Virreyes, D.f.
  26. Guadalajara, Jalisco
  27. Zapopan, Jalisco
  28. Monterrey, N.l.
  29. San Luis Potosi, SLP
  30. Mexico City,
  31. Amsterdam,
  32. Apeldoorn,
  33. Den Helder,
  34. Enschede,
  35. Nieuwegein,
  36. Bialystok,
  37. Gdansk,
  38. Myslowice,
  39. Poznan,
  40. Warszawa,
  41. Bucuresti,
  42. Cluj-Napoca,
  43. Iasi,
  44. Goteborg,
  45. Stockholm,
  46. Umea,
  47. Uppsala,
  48. Conwell,
  49. Fowey,
  50. London,
  51. Plymouth,
  52. St. Austell,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
Official Title  ICMJE 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
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.
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
  • Menstruation Disturbances
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
Estimated Enrollment  ICMJE
 (submitted: September 15, 2005)
526
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 exclusion applies.

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 Argentina,   Brazil,   Chile,   Denmark,   Finland,   Germany,   Mexico,   Netherlands,   Poland,   Romania,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195559
Other Study ID Numbers  ICMJE 0858A4-318
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
Principal Investigator:Trial ManagerFor Argentina, Chile, [email protected]
Principal Investigator:Trial ManagerFor Brazil, [email protected]
Principal Investigator:Trial ManagerFor Denmark, Finland, Sweden, [email protected]
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Mexico, [email protected]
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
Principal Investigator:Trial ManagerspFor Poland, [email protected]
Principal Investigator:Trial ManagerFor Romania, [email protected]
Principal Investigator:Trial ManagerFor UK, [email protected]
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