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.

NCT00307801 Phase 3 COMPLETED Results posted

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

Details

Lead sponsor	Bayer
Phase	Phase 3
Status	COMPLETED
Enrolment	231
Start date	2006-02
Completion	2008-05

Conditions

• Metrorrhagia

Interventions

• Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
• Placebo

Primary outcomes

• Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms — Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
  At least 6, up to 8 criteria to be met in complete response during 90-day period: no bleeding episodes(BE) \>7 days, no \>4 BE, no BE with blood loss (menstrual blood loss, MBL) ≥80 mL, no \>1 BE increase from baseline, no increase from baseline in individual patient's total number of bleeding days and total number of bleeding days not \>24 days. Additionally, for subjects included with prolonged bleeding: decrease between maximum duration during run-in and efficacy ≥2 days excessive bleeding: MBL associated with each episode decreased by ≥50% from average of qualifying episodes during run-in.

Countries

Australia, Czechia, Finland, Germany, Hungary, Netherlands, Poland, Sweden, Ukraine, United Kingdom