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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Premenstrual Syndrome

Treatments: Drug: Levonorgestrel/Ethinyl Estradiol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00161681

0858A2-322

B3121024 (Other Identifier)

Details and patient eligibility

About

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

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind