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

Completed · Phase 3

Conditions studied: Menstruation Disturbances, Premenstrual Syndrome

In brief

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).

Key facts

Study ID

NCT00128934

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

744

Starts

2005-08-01

Expected to finish

2007-12-01

Last updated by the study team

2007-12-27

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Carmichael, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Longmont, Colorado, United States
• Study site — Middletown, Connecticut, United States
• Study site — New Haven, Connecticut, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Adventure, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Pembroke Pines, 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 — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.