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

Phase 3

Completed

• Conditions: Menstruation Disturbances; Premenstrual Syndrome

• Registration Number: NCT00128934
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-08
• Study First Submitted QC: 2005-08-08
• Study First Posted: 2005-08-10
• Status Verified: 2007-12
• Study Completion: 2007-12
• Last Update Submitted: 2007-12-18
• Last Update Posted: 2007-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 744

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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