The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
1 pill per day taken orally over 7 cycles of 28 pills per cycle
1 pill per day taken orally over 7 cycles of 28 pills per cycle
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.
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
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.
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
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)
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Private Practice Dr. Ian Fraser
Ashfield, New South Wales, Australia
King Edward Memorial Hospital
Subiaco, Western Australia, Australia
Gynekologicka ambulance Vanda Horejsi, MD
České Budějovice, Czechia
Center for Clinical& Basic Research
Pardubice, Czechia
Gynekologicko-poradnicka ambulance Dr. Hlavackova
Písek, Czechia
Lekarsky dum Praha 7 a.s.Gynekologicka ambulance Dr. Jenicek
Prague, Czechia
Adenova Lääkärikeskus Oy
Espoo, Finland
Terveystalo Lahti
Lahti, Finland
Koskiklinikka
Tampere, Finland
Ylioppilaiden terveydenhoitosäätiö, Turku
Turku, Finland
...and 26 more locations
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
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
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
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.
Time frame: From baseline (visit 5, day 1) up to treatment day 84
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.
Time frame: From baseline (visit 5, day 1) up to 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.
Time frame: From baseline (visit 5, day 1) up to treatment day 84
Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 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.
Time frame: From baseline (visit 5, day 1) up to treatment day 196
Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment
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
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.
Time frame: Cycle 1 = 28 days (one cycle)
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.
Time frame: Cycle 3 = 28 days (one cycle)
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.
Time frame: Cycle 7 = 28 days (one cycle)
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.
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
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.
Time frame: Cycle 1 = 28 days (one cycle)
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.
Time frame: Cycle 3 = 28 days (one cycle)
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.
Time frame: Cycle 7 = 28 days (one cycle)
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.
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
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.
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
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.
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
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.
Time frame: Baseline (visit 5) and 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.
Time frame: Baseline (visit 5) and 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.
Time frame: Baseline (visit 5) and 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.
Time frame: Baseline (visit 5, day 1) and 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.
Time frame: Baseline (visit 5, day 1) and 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.
Time frame: Baseline (visit 5, day 1) and treatment day 84
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.
Time frame: Baseline (visit 5, day 1) and 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.
Time frame: Baseline (visit 5, day 1) and treatment day 84
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.
Time frame: Baseline (visit 5, day 1) and 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.
Time frame: Baseline (visit 5, day 1) and treatment day 84
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.
Time frame: Baseline (visit 5, day 1) and treatment day 196
Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 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.
Time frame: Baseline (visit 5, day 1) and treatment day 84
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.
Time frame: Baseline (visit 5, day 1) and treatment day 196
Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 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.
Time frame: Treatment day 84
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.
Time frame: 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.
Time frame: Treatment day 84
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.
Time frame: 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.
Time frame: Treatment day 84
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.
Time frame: 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.
Time frame: Treatment day 84
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.
Time frame: 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.
Time frame: Treatment day 84
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.
Time frame: 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.
Time frame: Treatment day 84
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.
Time frame: 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.
Time frame: Treatment day 84
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.
Time frame: 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.
Time frame: Treatment day 84
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.
Time frame: 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.
Time frame: Treatment day 84
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.
Time frame: 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.
Time frame: Treatment day 84
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.
Time frame: Treatment day 196