Conditions: Metrorrhagia
Keywords: Dysfunctional Uterine Bleeding
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 190
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:
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Arms:
arm 1: A blister card consists of 28 pills 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: 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 placeboA blister card consists of 28 pills taken orally once a day for 28 days (one cycle) intervention 2: Matching placebo to be taken orally daily.

Protocol document: