At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 190 enrolled
Drug / intervention
Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) +1 moredrug
Likely dose
Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) 3 mgfrom 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 190 participants across 46 sites in 2 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
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2005
First PostedFeb 2006
Primary CompletionMay 2008
TodayJul 2026
First PostedFeb 17, 2006
Enrollment StartDec 1, 2005
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.4 years ago
Interventions
Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)drug
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)
Placebodrug
Matching placebo to be taken orally daily.