NCT00293059

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metrorrhagia

Interventions

Type	Name	Description
DRUG	Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)	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)
DRUG	Placebo	Matching placebo to be taken orally daily.

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2006-02-17
• Last updated: 2013-11-27
• Results posted: 2011-06-06

Locations

46 sites across 2 countries: United States, Canada