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

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Levonorgestrel; Polyestradiol phosphate

Criteria

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.