Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00307801
First received: March 27, 2006
Last updated: August 25, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.


Condition Intervention Phase
Metrorrhagia
Drug: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms [ Time Frame: Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline (visit 5, day 1) up to treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline (visit 5, day 1) up to treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline (visit 5, day 1) up to treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline (visit 5, day 1) up to treatment day 196 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Cycle 1 = 28 days (one cycle) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Cycle 3 = 28 days (one cycle) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Cycle 7 = 28 days (one cycle) ] [ Designated as safety issue: No ]
    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. [ 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Cycle 1 = 28 days (one cycle) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Cycle 3 = 28 days (one cycle) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Cycle 7 = 28 days (one cycle) ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (visit 5) and treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (visit 5) and treatment day 196 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline (visit 5) and treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (visit 5, day 1) and treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (visit 5, day 1) and treatment day 196 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline (visit 5, day 1) and treatment day 84 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline (visit 5, day 1) and treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (visit 5, day 1) and treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (visit 5, day 1) and treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (visit 5, day 1) and treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (visit 5, day 1) and treatment day 196 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline (visit 5, day 1) and treatment day 84 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline (visit 5, day 1) and treatment day 196 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
    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.


Enrollment: 231
Study Start Date: February 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
Drug: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
1 pill per day taken orally over 7 cycles of 28 pills per cycle
Placebo Comparator: Placebo
Matching placebo to be taken orally daily.
Drug: Placebo
1 pill per day taken orally over 7 cycles of 28 pills per cycle

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307801

  Show 36 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00307801     History of Changes
Other Study ID Numbers: 91470, 2005-004340-32, 308961
Study First Received: March 27, 2006
Results First Received: March 2, 2011
Last Updated: August 25, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Bayer:
Dysfunctional uterine bleeding

Additional relevant MeSH terms:
Hemorrhage
Metrorrhagia
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Dienogest
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on July 26, 2014