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

Phase 3

Completed

• Conditions: Premenstrual Syndrome

• Registration Number: NCT00161681
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2007-05
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo

Secondary Outcome Measures

Name	Time	Method
To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo