Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding.

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Inclusion Criteria:

• Women 18 years or older
• And with a diagnosis of dysfunctional uterine bleeding without organic pathology
• And with at least one of the following symptoms: prolonged, frequent or excessive bleeding.

Exclusion Criteria:

• The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
• Women with a history of endometrial ablation or dilatation and curettage within 2 months prior to study start will be excluded.