Official Title: “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”

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).

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: levonorgestrel/ethinyl estradiol

Primary Measures

• Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score

Secondary Measures

• Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 49 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor, MD Study Director Wyeth  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00128934

Study ID Number: 0858A4-316

ClinicalTrials.gov Identifier: NCT00128934

Health Authority: Canada: Health Canada