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.

Bayer45 sites in 2 countries190 target enrollmentDecember 2005

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: 190
Locations: 45
Primary Endpoint: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms
Status: Completed
Last Updated: 12 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

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Registry

clinicaltrials.gov

Start Date

December 2005

End Date

May 2008

Last Updated

12 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
•With 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 history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.

Arms & Interventions

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

A blister card consists of 28 pills 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: during a time period of 90 days under treatment

Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) \>7 days, no \>4 BE, no BE with MBL \>=80 mL, no \>1 BE increase from baseline, no increase from baseline in an individual participant's total number of bleeding days and total number of bleeding days not \>24 days. Additionally, for participants 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

Proportion of Participants Cured From Prolonged Bleeding(during a time period of 90 days under treatment)
Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84(from baseline up to treatment day 84)
Menstrual Blood Loss Volume for All Participants at Cycle 7(28 days)
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1(28 days)
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3(28 days)
Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196(baseline and treatment day 196)
Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196(baseline and treatment day 196)
Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84(baseline and treatment day 84)
Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196(baseline and treatment day 196)
Proportion of Participants Cured From Frequent Bleeding(during a time period of 90 days under treatment)
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196(from baseline up to treatment day 196)
Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196(from baseline up to treatment day 196)
Menstrual Blood Loss Volume for All Participants at Cycle 1(28 days)
Menstrual Blood Loss Volume for All Participants at Cycle 3(28 days)
Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84(baseline and treatment day 84)
Proportion of Participants Cured From Excessive Bleeding(during a time period of 90 days under treatment)
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84(from baseline up to treatment day 84)
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)
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)
Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment(baseline and reference period of 90 days under treatment)
Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84(treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84(treatment day 84)
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7(28 days)
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)
Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84(baseline and treatment day 84)
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 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)
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 (Out-of-pocket Expenses) at Treatment Day 84(treatment day 84)
Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84(treatment day 84)
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)
Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84(baseline and 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 (Regular Daily Activities) at Treatment Day 196(treatment day 196)
Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196(baseline 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 (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196(treatment day 196)
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 (Additional Unscheduled Procedures) at Treatment Day 196(treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196(treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196(treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196(treatment day 196)
Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 196(baseline and treatment day 196)
Change From Baseline in Serum Ferritin Concentration at Treatment Day 84(baseline and treatment day 84)
Change From Baseline in Serum Ferritin Concentration at Treatment Day 196(baseline and treatment day 196)
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 196(treatment day 196)
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196(treatment day 196)
Change From Baseline in Hemoglobin Concentration at Treatment Day 84(baseline and treatment day 84)
Change From Baseline in Hemoglobin Concentration at Treatment Day 196(baseline and treatment day 196)