At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 231 enrolled
Drug / intervention
Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) and Placebo for Metrorrhagia. Completed, enrolled 231 participants across 36 sites in 10 countries.
Detailed Summary
The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetrorrhagia
CountriesAustralia, Czechia, Finland, Germany, Hungary, Netherlands, Poland, Sweden, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedMar 2006
Primary CompletionMay 2008
TodayJul 2026
First PostedMar 28, 2006
Enrollment StartFeb 1, 2006
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.3 years ago
Interventions
Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)drug
1 pill per day taken orally over 7 cycles of 28 pills per cycle
Placebodrug
1 pill per day taken orally over 7 cycles of 28 pills per cycle