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Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Primary Purpose

Metrorrhagia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

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

Placebo

About this trial

This is an interventional treatment trial for Metrorrhagia focused on measuring Dysfunctional uterine bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

Placebo

Arm Description

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.

Matching placebo to be taken orally daily.

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

Proportion of Participants Cured From Prolonged Bleeding

Prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days. Cure from prolonged bleeding: no bleeding episodes lasting more than 7 days and the decrease between maximum duration during run-in and maximum duration during the efficacy phase was at least 2 days.

Proportion of Participants Cured From Excessive Bleeding

Excessive bleeding:>=2 bleeding episodes each with blood loss volume (MBL) of >=80 mL in 90-day period, assessed by alkaline hematin method. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. Cure from excessive bleeding: MBL in each episode <80 mL + blood loss volume associated with each bleeding episode is decrease of ≥50% from average of qualifying bleeding episodes (with blood loss volume ≥80 mL per episode during run-in)

Proportion of Participants Cured From Frequent Bleeding

Frequent bleeding: greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall. Cure from frequent bleeding: no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and no increase from baseline in an individual patient's total number of bleeding days occurred

Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84

According to the investigator's global assessment scale "improved" was defined as being classified as 'very much improved', 'much improved', or 'improved' and "not improved" was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 84 compared with admission to study data.

Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196

Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 84

According to the patient's global assessment scale "improved" was defined as being classified as 'very much improved', 'much improved', or 'improved' and "not improved" was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Patients assessed the overall improvement at day 84 compared with admission to the study condition.

Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 196

According to the patient´s global assessment scale "improved" was defined as being classified as 'very much improved', 'much improved', or 'improved' and "not improved" was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Patients assessed the overall improvement at day 196 compared with admission to the study condition.

Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment

Menstrual blood loss volume as assessed by the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. A negative value indicates a reduction in blood loss after treatment.

Menstrual Blood Loss Volume for All Participants at Cycle 1

Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.

Menstrual Blood Loss Volume for All Participants at Cycle 3

Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.

Menstrual Blood Loss Volume for All Participants at Cycle 7

Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.

Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment.

Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.

Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1.

Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.

Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3.

Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.

Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7.

Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.

Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment

A bleeding episode is characterized by the following: • Bleeding for at least 2 days • Bleeding days can be separated by no more than 1 bleeding-free day • An episode stops with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. negative value indicates a reduction from baseline in the number of episodes while under treatment.

Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment

A bleeding day is a day on which sanitary protection is required. The number of bleeding days was determined for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.

Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment

The number of total sanitary protection items used during the 90 days before treatment (baseline) and those used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to baseline.

Change From Baseline in Hemoglobin Concentration at Treatment Day 84

Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.

Change From Baseline in Hemoglobin Concentration at Treatment Day 196

Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.

Change From Baseline in Hematocrit at Treatment Day 196.

Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.

Change From Baseline in Ferritin Concentration at Treatment Day 84

Ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 84.

Change From Baseline in Ferritin Concentration at Treatment Day 196

Ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 196.

Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 84.

The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.

Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 196.

Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 84

The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133.

Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 196

Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 84

The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594.

Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 196

Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84.

The visual analogue scale (ie, "thermometer") had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked "your own health state today" to the appropriate point on the thermometer scale.

Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196.

Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 84.

The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed.

Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 196.

Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 84

The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study.

Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 196

Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 84.

The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working.

Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 196.

Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 84

The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities.

Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 196.

Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 84

The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed.

Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 196

Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 84

The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed.

Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 196

Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 84

The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed.

Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 196

Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 84

The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed.

Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 196

Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 84

The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed.

Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 196

Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 84

The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed.

Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 196

Full Information

NCT ID

NCT00307801

First Posted

March 27, 2006

Last Updated

December 8, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00307801

Brief Title

Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metrorrhagia

Keywords

Dysfunctional uterine bleeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

231 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo to be taken orally daily.

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

1 pill per day taken orally over 7 cycles of 28 pills per cycle

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

1 pill per day taken orally over 7 cycles of 28 pills per cycle

Primary Outcome Measure Information:

Title

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

Description

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

Secondary Outcome Measure Information:

Title

Proportion of Participants Cured From Prolonged Bleeding

Description

Time Frame

Title

Proportion of Participants Cured From Excessive Bleeding

Description

Time Frame

Title

Proportion of Participants Cured From Frequent Bleeding

Description

Time Frame

Title

Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84

Description

Time Frame

From baseline (visit 5, day 1) up to treatment day 84

Title

Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196

Description

Time Frame

From baseline (visit 5, day 1) up to treatment day 196

Title

Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 84

Description

Time Frame

From baseline (visit 5, day 1) up to treatment day 84

Title

Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 196

Description

Time Frame

From baseline (visit 5, day 1) up to treatment day 196

Title

Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment

Description

Time Frame

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

Title

Menstrual Blood Loss Volume for All Participants at Cycle 1

Description

Time Frame

Cycle 1 = 28 days (one cycle)

Title

Menstrual Blood Loss Volume for All Participants at Cycle 3

Description

Time Frame

Cycle 3 = 28 days (one cycle)

Title

Menstrual Blood Loss Volume for All Participants at Cycle 7

Description

Time Frame

Cycle 7 = 28 days (one cycle)

Title

Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment.

Description

Time Frame

Title

Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1.

Description

Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.

Time Frame

Cycle 1 = 28 days (one cycle)

Title

Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3.

Description

Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.

Time Frame

Cycle 3 = 28 days (one cycle)

Title

Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7.

Description

Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.

Time Frame

Cycle 7 = 28 days (one cycle)

Title

Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment

Description

Time Frame

Title

Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment

Description

Time Frame

Title

Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment

Description

Time Frame

Title

Change From Baseline in Hemoglobin Concentration at Treatment Day 84

Description

Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.

Time Frame

Baseline (visit 5) and treatment day 84

Title

Change From Baseline in Hemoglobin Concentration at Treatment Day 196

Description

Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.

Time Frame

Baseline (visit 5) and treatment day 196

Title

Change From Baseline in Hematocrit at Treatment Day 196.

Description

Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.

Time Frame

Baseline (visit 5) and treatment day 196

Title

Change From Baseline in Ferritin Concentration at Treatment Day 84

Description

Ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 84.

Time Frame

Baseline (visit 5, day 1) and treatment day 84

Title

Change From Baseline in Ferritin Concentration at Treatment Day 196

Description

Ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 196.

Time Frame

Baseline (visit 5, day 1) and treatment day 196

Title

Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 84.

Description

Time Frame

Baseline (visit 5, day 1) and treatment day 84

Title

Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 196.

Description

Time Frame

Baseline (visit 5, day 1) and treatment day 196

Title

Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 84

Description

Time Frame

Baseline (visit 5, day 1) and treatment day 84

Title

Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 196

Description

Time Frame

Baseline (visit 5, day 1) and treatment day 196

Title

Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 84

Description

Time Frame

Baseline (visit 5, day 1) and treatment day 84

Title

Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 196

Description

Time Frame

Baseline (visit 5, day 1) and treatment day 196

Title

Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84.

Description

Time Frame

Baseline (visit 5, day 1) and treatment day 84

Title

Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196.

Description

Time Frame

Baseline (visit 5, day 1) and treatment day 196

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 84.

Description

Time Frame

Treatment day 84

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 196.

Description

Time Frame

Treatment day 196

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 84

Description

Time Frame

Treatment day 84

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 196

Description

Time Frame

Treatment day 196

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 84.

Description

Time Frame

Treatment day 84

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 196.

Description

Time Frame

Treatment day 196

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 84

Description

Time Frame

Treatment day 84

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 196.

Description

Time Frame

Treatment day 196

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 84

Description

Time Frame

Treatment day 84

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 196

Description

Time Frame

Treatment day 196

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 84

Description

Time Frame

Treatment day 84

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 196

Description

Time Frame

Treatment day 196

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 84

Description

Time Frame

Treatment day 84

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 196

Description

Time Frame

Treatment day 196

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 84

Description

Time Frame

Treatment day 84

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 196

Description

Time Frame

Treatment day 196

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 84

Description

Time Frame

Treatment day 84

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 196

Description

Time Frame

Treatment day 196

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 84

Description

Time Frame

Treatment day 84

Title

Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 196

Description

Time Frame

Treatment day 196

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

Facility Name

Private Practice Dr. Ian Fraser

City

Ashfield

State/Province

New South Wales

ZIP/Postal Code

NSW 2131

Country

Australia

Facility Name

King Edward Memorial Hospital

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

Gynekologicka ambulance Vanda Horejsi, MD

City

Ceske Budejovice

ZIP/Postal Code

37001

Country

Czech Republic

Facility Name

Center for Clinical& Basic Research

City

Pardubice

ZIP/Postal Code

2667

Country

Czech Republic

Facility Name

Gynekologicko-poradnicka ambulance Dr. Hlavackova

City

Pisek

ZIP/Postal Code

39701

Country

Czech Republic

Facility Name

Lekarsky dum Praha 7 a.s.Gynekologicka ambulance Dr. Jenicek

City

Praha 7

ZIP/Postal Code

170 00

Country

Czech Republic

Facility Name

Adenova Lääkärikeskus Oy

City

Espoo

ZIP/Postal Code

02100

Country

Finland

Facility Name

Terveystalo Lahti

City

Lahti

ZIP/Postal Code

15110

Country

Finland

Facility Name

Koskiklinikka

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Ylioppilaiden terveydenhoitosäätiö, Turku

City

Turku

ZIP/Postal Code

20540

Country

Finland

Facility Name

Praxis Hr. Dr. U. Kohoutek

City

Karlsruhe

State/Province

Baden-Württemberg

ZIP/Postal Code

76199

Country

Germany

Facility Name

Praxis Hr. Dr. S. Schönian

City

Rheinstetten

State/Province

Baden-Württemberg

ZIP/Postal Code

76287

Country

Germany

Facility Name

Praxis Hr. Dr. K. Greven

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30459

Country

Germany

Facility Name

ClinPharm International GmbH

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01067

Country

Germany

Facility Name

emovis GmbH

City

Berlin

ZIP/Postal Code

10629

Country

Germany

Facility Name

University of Semmelweis

City

Budapest

ZIP/Postal Code

1082

Country

Hungary

Facility Name

Selya Janos Hospital

City

Komarom

ZIP/Postal Code

2921

Country

Hungary

Facility Name

Borsod-Abauj-Zemplen County Hospital

City

Miskolc

ZIP/Postal Code

3501

Country

Hungary

Facility Name

Medisch Spectrum Twente, Locatie Ariensplein

City

Enschede

ZIP/Postal Code

7511 JX

Country

Netherlands

Facility Name

PreCare Trial & Recruitment

City

Geleen

ZIP/Postal Code

6166

Country

Netherlands

Facility Name

Menox BV

City

Nijmegen

ZIP/Postal Code

6525 EC

Country

Netherlands

Facility Name

Poliklinika Ginekologiczna- Poloznicza

City

Bialystok

ZIP/Postal Code

15-435

Country

Poland

Facility Name

Instytut Centrum Zdrowia Matki Polki

City

Lodz

ZIP/Postal Code

93-338

Country

Poland

Facility Name

SPSK nr 1

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Szpital Kliniczny nr 3

City

Poznan

ZIP/Postal Code

60-525

Country

Poland

Facility Name

CSK MSWiA

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Skånes Universitetssjukhus

City

Lund

ZIP/Postal Code

22185

Country

Sweden

Facility Name

Karolinska Universitetssjukhuset Huddinge

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Akademiska Sjukhuset

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

Dept. of obstetrics and gynaecology

City

Kiev

ZIP/Postal Code

01030

Country

Ukraine

Facility Name

Instr. of Pediatrics, Obstetrics & Gynecology

City

Kiev

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Kyiv Medical Academy of Postdyploma Education

City

Kiev

ZIP/Postal Code

04210

Country

Ukraine

Facility Name

Lviv Regional Center Perinatal Center

City

Lviv

Country

Ukraine

Facility Name

Bridge House Medical Centre

City

Cheadle

State/Province

Cheshire

ZIP/Postal Code

SK8 5LL

Country

United Kingdom

Facility Name

Luton & Dunstable Hospital

City

Luton

ZIP/Postal Code

LU4 0DZ

Country

United Kingdom

Facility Name

MeDiNova Research

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

22240178

Citation

Fraser IS, Jensen J, Schaefers M, Mellinger U, Parke S, Serrani M. Normalization of blood loss in women with heavy menstrual bleeding treated with an oral contraceptive containing estradiol valerate/dienogest. Contraception. 2012 Aug;86(2):96-101. doi: 10.1016/j.contraception.2011.11.011. Epub 2012 Jan 10.

Results Reference

result

PubMed Identifier

21774563

Citation

Fraser IS, Parke S, Mellinger U, Machlitt A, Serrani M, Jensen J. Effective treatment of heavy and/or prolonged menstrual bleeding without organic cause: pooled analysis of two multinational, randomised, double-blind, placebo-controlled trials of oestradiol valerate and dienogest. Eur J Contracept Reprod Health Care. 2011 Aug;16(4):258-69. doi: 10.3109/13625187.2011.591456.

Results Reference

result

PubMed Identifier

21784734

Citation

Fraser IS, Romer T, Parke S, Zeun S, Mellinger U, Machlitt A, Jensen JT. Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind Phase III trial. Hum Reprod. 2011 Oct;26(10):2698-708. doi: 10.1093/humrep/der224. Epub 2011 Jul 21.

Results Reference

result

PubMed Identifier

22927764

Citation

Wasiak R, Filonenko A, Vanness DJ, Wittrup-Jensen KU, Stull DE, Siak S, Fraser I. Impact of estradiol-valerate/dienogest on work productivity and activities of daily living in European and Australian women with heavy menstrual bleeding. Int J Womens Health. 2012;4:271-8. doi: 10.2147/IJWH.S31740. Epub 2012 Jul 12.

Results Reference

result

PubMed Identifier

23439617

Citation

Fraser IS, Zeun S, Parke S, Wilke B, Junge W, Serrani M. Improving the objective quality of large-scale clinical trials for women with heavy menstrual bleeding: experience from 2 multi-center, randomized trials. Reprod Sci. 2013 Jul;20(7):745-54. doi: 10.1177/1933719113477492. Epub 2013 Feb 25.

Results Reference

result

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

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Learn more about this trial

Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

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Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Metrorrhagia

About this trial

Eligibility Criteria

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Arms of the Study

Arm 1

Arm 2

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Primary Outcome Measures

Secondary Outcome Measures

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1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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