Conditions: Metrorrhagia
Keywords: Dysfunctional uterine bleeding
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 231
Healthy volunteers: no

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

Detailed description:
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.

Arms:
arm 1: A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo. arm 2: Matching placebo to be taken orally daily.

Interventions: intervention 1: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Placebo
Intervention descriptions: intervention 1: 1 pill per day taken orally over 7 cycles of 28 pills per cycle intervention 2: 1 pill per day taken orally over 7 cycles of 28 pills per cycle

Protocol document: