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

Completed · Phase 3

Conditions studied: Premenstrual Syndrome

In brief

The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.

Key facts

Study ID

NCT00161681

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

200

Starts

2005-07-01

Expected to finish

2006-08-01

Last updated by the study team

2013-02-08

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Longmont, Colorado, United States
• Study site — Aventura, Florida, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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