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.

Bayer36 sites in 10 countries231 target enrollmentFebruary 2006

ConditionsMetrorrhagia

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

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

Overview

Phase: Phase 3
Intervention: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
Conditions: Metrorrhagia
Sponsor: Bayer
Enrollment: 231
Locations: 36
Primary Endpoint: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

May 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women 18 years or older
•And with a diagnosis of dysfunctional uterine bleeding without organic pathology
•And with at least one of the following symptoms: prolonged, frequent or excessive bleeding.

Exclusion Criteria

•The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
•Women with a history of endometrial ablation or dilatation and curettage within 2 months prior to study start will be excluded.

Arms & Interventions

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

A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 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 placebo.

Intervention: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)

Placebo

Matching placebo to be taken orally daily.

Intervention: Placebo

Outcomes

Primary Outcomes

Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms

Time Frame: 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.

Secondary Outcomes

Menstrual Blood Loss Volume for All Participants at Cycle 3(Cycle 3 = 28 days (one cycle))
Change From Baseline in Ferritin Concentration at Treatment Day 196(Baseline (visit 5, day 1) and treatment day 196)
Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 196(From baseline (visit 5, day 1) up to treatment day 196)
Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment(Baseline and reference period of 90 days 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)
Proportion of Participants Cured From Prolonged Bleeding(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)
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84(From baseline (visit 5, day 1) up to treatment day 84)
Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 84(From baseline (visit 5, day 1) up to treatment day 84)
Proportion of Participants Cured From Excessive Bleeding(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)
Menstrual Blood Loss Volume for All Participants at Cycle 1(Cycle 1 = 28 days (one cycle))
Menstrual Blood Loss Volume for All Participants at Cycle 7(Cycle 7 = 28 days (one cycle))
Proportion of Participants Cured From Frequent Bleeding(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)
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196(From baseline (visit 5, day 1) up to treatment day 196)
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3.(Cycle 3 = 28 days (one cycle))
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7.(Cycle 7 = 28 days (one cycle))
Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 196(Treatment day 196)
Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment(Baseline and reference period of 90 days 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)
Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment.(Baseline and reference period of 90 days 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)
Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment(Baseline and reference period of 90 days 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)
Change From Baseline in Ferritin Concentration at Treatment Day 84(Baseline (visit 5, day 1) and treatment day 84)
Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 84.(Baseline (visit 5, day 1) and treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 196.(Treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 196(Treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 196(Treatment day 196)
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1.(Cycle 1 = 28 days (one cycle))
Change From Baseline in Hemoglobin Concentration at Treatment Day 84(Baseline (visit 5) and treatment day 84)
Change From Baseline in Hemoglobin Concentration at Treatment Day 196(Baseline (visit 5) and treatment day 196)
Change From Baseline in Hematocrit at Treatment Day 196.(Baseline (visit 5) and treatment day 196)
Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 196(Baseline (visit 5, day 1) and treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 84(Treatment day 84)
Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment(Baseline and reference period of 90 days 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)
Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 84(Baseline (visit 5, day 1) and treatment day 84)
Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 196(Baseline (visit 5, day 1) and treatment day 196)
Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 84(Baseline (visit 5, day 1) and treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 196(Treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 84.(Treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 196.(Treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 84(Treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 84(Treatment day 84)
Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 196.(Baseline (visit 5, day 1) and treatment day 196)
Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196.(Baseline (visit 5, day 1) and treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 196.(Treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 84(Treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 196(Treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 196(Treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 84(Treatment day 84)
Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84.(Baseline (visit 5, day 1) and treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 84.(Treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 84(Treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 84(Treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 84(Treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 196(Treatment day 196)