Trials / Completed
CompletedNCT00307801
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
- 231 (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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 1 pill per day taken orally over 7 cycles of 28 pills per cycle |
| DRUG | Placebo | 1 pill per day taken orally over 7 cycles of 28 pills per cycle |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2008-05-01
- Completion
- 2008-05-01
- First posted
- 2006-03-28
- Last updated
- 2014-12-30
- Results posted
- 2011-07-29
Locations
36 sites across 10 countries: Australia, Czechia, Finland, Germany, Hungary, Netherlands, Poland, Sweden, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00307801. Inclusion in this directory is not an endorsement.