Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

Wyeth

Status and phase: Completed; Phase 3

Conditions: Menstruation Disturbances; Premenstrual Syndrome

Treatments: Drug: Levonorgestrel/Ethinyl Estradiol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195559

0858A4-318

Details and patient eligibility

About

The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.

Enrollment: 526 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 exclusion applies.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind