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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
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

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.

Sites / Locations

  • Private Practice Dr. Ian Fraser
  • King Edward Memorial Hospital
  • Gynekologicka ambulance Vanda Horejsi, MD
  • Center for Clinical& Basic Research
  • Gynekologicko-poradnicka ambulance Dr. Hlavackova
  • Lekarsky dum Praha 7 a.s.Gynekologicka ambulance Dr. Jenicek
  • Adenova Lääkärikeskus Oy
  • Terveystalo Lahti
  • Koskiklinikka
  • Ylioppilaiden terveydenhoitosäätiö, Turku
  • Praxis Hr. Dr. U. Kohoutek
  • Praxis Hr. Dr. S. Schönian
  • Praxis Hr. Dr. K. Greven
  • ClinPharm International GmbH
  • emovis GmbH
  • University of Semmelweis
  • Selya Janos Hospital
  • Borsod-Abauj-Zemplen County Hospital
  • Medisch Spectrum Twente, Locatie Ariensplein
  • PreCare Trial & Recruitment
  • Menox BV
  • Poliklinika Ginekologiczna- Poloznicza
  • Instytut Centrum Zdrowia Matki Polki
  • SPSK nr 1
  • Szpital Kliniczny nr 3
  • CSK MSWiA
  • Skånes Universitetssjukhus
  • Karolinska Universitetssjukhuset Huddinge
  • Akademiska Sjukhuset
  • Dept. of obstetrics and gynaecology
  • Instr. of Pediatrics, Obstetrics & Gynecology
  • Kyiv Medical Academy of Postdyploma Education
  • Lviv Regional Center Perinatal Center
  • Bridge House Medical Centre
  • Luton & Dunstable Hospital
  • MeDiNova Research

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
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 196 compared with admission to study data.
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.
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 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
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 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
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 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.
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.
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.
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 (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
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 (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.
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 (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.
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 (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
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 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
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 (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
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 (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
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 (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
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 (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
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.

Full Information

First Posted
March 27, 2006
Last Updated
December 8, 2014
Sponsor
Bayer
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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
No

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
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.
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
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.
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
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.
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
Title
Proportion of Participants Cured From Excessive Bleeding
Description
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)
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
Title
Proportion of Participants Cured From Frequent Bleeding
Description
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
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
Title
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84
Description
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.
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
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 196 compared with admission to study data.
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
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.
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
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.
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
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.
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
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.
Time Frame
Cycle 1 = 28 days (one cycle)
Title
Menstrual Blood Loss Volume for All Participants at Cycle 3
Description
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.
Time Frame
Cycle 3 = 28 days (one cycle)
Title
Menstrual Blood Loss Volume for All Participants at Cycle 7
Description
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.
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
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.
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 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
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.
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
Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment
Description
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.
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
Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment
Description
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.
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
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time Frame
Treatment day 196
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84.
Description
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.
Time Frame
Treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196.
Description
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.
Time Frame
Treatment day 196
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84
Description
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.
Time Frame
Treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196.
Description
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.
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
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.
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
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.
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
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.
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
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.
Time Frame
Treatment day 196
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84
Description
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.
Time Frame
Treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196
Description
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.
Time Frame
Treatment day 196
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84
Description
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.
Time Frame
Treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196
Description
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.
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
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.
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
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.
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
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.
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
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.
Time Frame
Treatment day 196

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
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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Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

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