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

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ClinicalTrials.gov Identifier: NCT00128934
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : December 27, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE August 8, 2005
First Posted Date  ICMJE August 10, 2005
Last Update Posted Date December 27, 2007
Study Start Date  ICMJE August 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2005)
Mean change in average Daily record of Severity of Problems 21-item total daily score
Change History Complete list of historical versions of study NCT00128934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2005)
Change from baseline in DRSP 21 item daily score based on the 5 days with highest DRSP scores in each "estimated" treatment cycle.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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, MD Wyeth 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