Status:
COMPLETED
Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Premenstrual Syndrome
Eligibility:
FEMALE
18-49 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00161681
Start Date
July 1 2005
End Date
August 1 2006
Last Update
February 8 2013
Active Locations (48)
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1
Huntsville, Alabama, United States, 35801
2
Peoria, Arizona, United States, 85381
3
Phoenix, Arizona, United States, 85031
4
Phoenix, Arizona, United States, 85032