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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 With diagnosis of dysfunctional uterine bleeding without organic pathology And with at least one of the following symptoms: prolonged, frequent, or excessive bleeding Exclusion Criteria: The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study. Women with history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.

Sites / Locations

  • Women and Child, LPP
  • Marin Endocrine Associates
  • Impact Clinical Trials - Los Angeles
  • Blue Hill Medical Group
  • Genesis Center for Clinical Research
  • Medical Center for Clinical Research
  • Women's Health Care, Inc.
  • Clinical Trial Center of Colorado
  • Clinical Trial Center of Colorado
  • South Florida Medical Research
  • Women's Medical Research Group, LLC
  • Clinical Physiology Associates, Inc.
  • New Age Medical Research Corp.
  • Insignia Care for Women, P.A.
  • Mount Vernon Clinical Research
  • Atlanta West Women's Center
  • Women's Health Practice
  • Physicians Research Group
  • Advanced Biomedical Research of America
  • NYU Langone Medical Center
  • Eastern Carolina Women's Center
  • Hawthorne Medical Research, Inc.
  • Womens Medical Center
  • Reproductive Medical Research
  • Rapid Medical Research Inc.
  • Oregon Health and Science University
  • Clinical Research of Philadelphia, LLC
  • Women's Health Care Group of PA
  • South Carolina Clinical Research Center
  • Brown Clinic, P.L.L.P.
  • New South Medical
  • Advanced Research Associates
  • Obstetrical & Gynecological Associates, PA
  • Research Across America
  • National Clinical Research, Inc.
  • North Spokane Women's Clinic
  • Dr. John Lenihan, MD
  • Maritimes Research Center
  • Total Concept Health Care Inc.
  • Prime Health Research
  • Centre d'étude clinique de Montréal Inc.
  • Les Gynecologues Associes
  • Clinique de Gynecologie
  • Q & T Research, Inc.
  • Clinique Médicale des Campus
  • Clinique Recherche en Sante des Femmes Inc.

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 card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo

Matching placebo to be taken orally daily

Outcomes

Primary Outcome Measures

Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms
Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) >7 days, no >4 BE, no BE with MBL >=80 mL, no >1 BE increase from baseline, no increase from baseline in an individual participant's total number of bleeding days and total number of bleeding days not >24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy >=2 days excessive bleeding: MBL associated with each episode decreased by >=50% from average of qualifying episodes during run-in.

Secondary Outcome Measures

Proportion of Participants Cured From Prolonged Bleeding
Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days.
Proportion of Participants Cured From Frequent Bleeding
Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase.
Proportion of Participants Cured From Excessive Bleeding
Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase.
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84
The investigators assessed the participants' change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196
The investigators assessed the participants' change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.
Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84
Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.
Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196
Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.
Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment
Menstrual blood loss was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. 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 was determined using the alkaline hematin method after participants were on treatment for one cycle
Menstrual Blood Loss Volume for All Participants at Cycle 3
Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles
Menstrual Blood Loss Volume for All Participants at Cycle 7
Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles
Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment
The blood loss volume 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) was determined 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
The blood loss volume 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) was determined using the alkaline hematin method after participants were on treatment for one cycle.
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3
The blood loss volume 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) was determined using the alkaline hematin method after participants were on treatment for 3 cycles.
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7
The blood loss volume 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) was determined using the alkaline hematin method after participants were on treatment for 7 cycles.
Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment
The number of bleeding days was determine 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 Bleeding Episodes to the Reference Period of 90 Days Under Treatment
A bleeding episode was one that lasted for at least 2 days, and where the bleeding days were separated by no more than 1 bleeding-free day. An episode stopped 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. A negative values indicates a reduction from baseline in the number of episodes while under treatment.
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-day run-in phase before treatment (baseline) and the number of total sanitary protection items 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 the number used before treatment.
Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores 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 was 132. The higher the score, the better the well being of the participant. 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) Scores 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 was 132. The higher the score, the better the well being of the participant. 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) Scores at Treatment Day 84
The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.
Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196
The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.
Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84
The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants 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 valuation score of .594. The change from the baseline score at day 84 is presented.
Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196
The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants 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 valuation score of .594. The change from the baseline score at day 196 is presented.
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. Participants 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. The change from baseline at day 84 is presented.
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. Participants 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. The change from baseline at day 196 is presented.
Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84
Participants were asked if there was any change in her employment status in the last 12 weeks. The proportion of participants with a change is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84
Participants were asked how many days and hours they missed from work during the past 12 weeks because of problems associated with 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
Participants were asked to rate on a scale of 0 to 10, how much their DUB affected productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.
Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84
Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do their regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing daily activities.
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84
Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84
Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84
Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84
Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who received such services is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84
Participants were asked to specify if they had out-of-pocket expenses because of 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 such expenses is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84
Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196
Participants were asked if there was any change in employment status in the last 12 weeks. The proportion of participants with a change is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196
Participants were asked how many days and hours were missed from work during the past 12 weeks because of problems associated with 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 196
Participants were asked to rate on a scale of 0 to 10, how much DUB affected their productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.
Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196
Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that 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 196
Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196
Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196
Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196
Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who had received such services is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196
Participants were asked to specify out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication, co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.
Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196
Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.
Change From Baseline in Hematocrit (Hct) Concentrations 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 Serum Ferritin Concentration at Treatment Day 84
Serum ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 84.
Change From Baseline in Serum Ferritin Concentration at Treatment Day 196
Serum ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 196.
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.

Full Information

First Posted
February 15, 2006
Last Updated
November 5, 2013
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00293059
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
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (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
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

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
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
Arm Type
Experimental
Arm Description
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
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
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 placeboA blister card consists of 28 pills taken orally once a day for 28 days (one cycle)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to be taken orally daily.
Primary Outcome Measure Information:
Title
Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms
Description
Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) >7 days, no >4 BE, no BE with MBL >=80 mL, no >1 BE increase from baseline, no increase from baseline in an individual participant's total number of bleeding days and total number of bleeding days not >24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy >=2 days excessive bleeding: MBL associated with each episode decreased by >=50% from average of qualifying episodes during run-in.
Time Frame
during a time period of 90 days under treatment
Secondary Outcome Measure Information:
Title
Proportion of Participants Cured From Prolonged Bleeding
Description
Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days.
Time Frame
during a time period of 90 days under treatment
Title
Proportion of Participants Cured From Frequent Bleeding
Description
Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase.
Time Frame
during a time period of 90 days under treatment
Title
Proportion of Participants Cured From Excessive Bleeding
Description
Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase.
Time Frame
during a time period of 90 days under treatment
Title
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84
Description
The investigators assessed the participants' change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.
Time Frame
from baseline up to treatment day 84
Title
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196
Description
The investigators assessed the participants' change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.
Time Frame
from baseline up to treatment day 196
Title
Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84
Description
Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.
Time Frame
from baseline up to treatment day 84
Title
Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196
Description
Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.
Time Frame
from baseline 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 was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. A negative value indicates a reduction in blood loss after treatment.
Time Frame
Baseline and reference period of 90 days under treatment
Title
Menstrual Blood Loss Volume for All Participants at Cycle 1
Description
Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for one cycle
Time Frame
28 days
Title
Menstrual Blood Loss Volume for All Participants at Cycle 3
Description
Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles
Time Frame
28 days
Title
Menstrual Blood Loss Volume for All Participants at Cycle 7
Description
Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles
Time Frame
28 days
Title
Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment
Description
The blood loss volume 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) was determined 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
Title
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1
Description
The blood loss volume 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) was determined using the alkaline hematin method after participants were on treatment for one cycle.
Time Frame
28 days
Title
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3
Description
The blood loss volume 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) was determined using the alkaline hematin method after participants were on treatment for 3 cycles.
Time Frame
28 days
Title
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7
Description
The blood loss volume 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) was determined using the alkaline hematin method after participants were on treatment for 7 cycles.
Time Frame
28 days
Title
Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment
Description
The number of bleeding days was determine 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
Title
Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment
Description
A bleeding episode was one that lasted for at least 2 days, and where the bleeding days were separated by no more than 1 bleeding-free day. An episode stopped 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. A negative values indicates a reduction from baseline in the number of episodes while under treatment.
Time Frame
baseline and reference period of 90 days under treatment
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-day run-in phase before treatment (baseline) and the number of total sanitary protection items 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 the number used before treatment.
Time Frame
baseline and reference period of 90 days under treatment
Title
Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores 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 was 132. The higher the score, the better the well being of the participant. 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 and treatment day 84
Title
Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores 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 was 132. The higher the score, the better the well being of the participant. 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 and treatment day 196
Title
Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84
Description
The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.
Time Frame
baseline and treatment day 84
Title
Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196
Description
The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.
Time Frame
baseline and treatment day 196
Title
Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84
Description
The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants 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 valuation score of .594. The change from the baseline score at day 84 is presented.
Time Frame
baseline and treatment day 84
Title
Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196
Description
The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants 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 valuation score of .594. The change from the baseline score at day 196 is presented.
Time Frame
baseline 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. Participants 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. The change from baseline at day 84 is presented.
Time Frame
baseline 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. Participants 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. The change from baseline at day 196 is presented.
Time Frame
baseline 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
Participants were asked if there was any change in her employment status in the last 12 weeks. The proportion of participants with a change is displayed.
Time Frame
treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84
Description
Participants were asked how many days and hours they missed from work during the past 12 weeks because of problems associated with 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 (Productivity While Working) at Treatment Day 84
Description
Participants were asked to rate on a scale of 0 to 10, how much their DUB affected productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.
Time Frame
treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84
Description
Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do their regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing daily activities.
Time Frame
treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84
Description
Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Time Frame
treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84
Description
Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Time Frame
treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84
Description
Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.
Time Frame
treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84
Description
Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who received such services is displayed.
Time Frame
treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84
Description
Participants were asked to specify if they had out-of-pocket expenses because of 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 such expenses is displayed.
Time Frame
treatment day 84
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84
Description
Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is 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
Participants were asked if there was any change in employment status in the last 12 weeks. The proportion of participants with a change is displayed.
Time Frame
treatment day 196
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196
Description
Participants were asked how many days and hours were missed from work during the past 12 weeks because of problems associated with 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 196
Description
Participants were asked to rate on a scale of 0 to 10, how much DUB affected their productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that 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 196
Description
Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that 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 196
Description
Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Time Frame
treatment day 196
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196
Description
Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Time Frame
treatment day 196
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196
Description
Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.
Time Frame
treatment day 196
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196
Description
Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who had received such services is displayed.
Time Frame
treatment day 196
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196
Description
Participants were asked to specify out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication, co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.
Time Frame
treatment day 196
Title
Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196
Description
Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.
Time Frame
treatment day 196
Title
Change From Baseline in Hematocrit (Hct) Concentrations 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 and treatment day 196
Title
Change From Baseline in Serum Ferritin Concentration at Treatment Day 84
Description
Serum ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 84.
Time Frame
baseline and treatment day 84
Title
Change From Baseline in Serum Ferritin Concentration at Treatment Day 196
Description
Serum ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 196.
Time Frame
baseline and treatment day 196
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 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 and 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 With diagnosis of dysfunctional uterine bleeding without organic pathology And with at least one of the following symptoms: prolonged, frequent, or excessive bleeding Exclusion Criteria: The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study. Women with history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.
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
Women and Child, LPP
City
Lake Havasu CIty
State/Province
Arizona
ZIP/Postal Code
86403
Country
United States
Facility Name
Marin Endocrine Associates
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Impact Clinical Trials - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Facility Name
Blue Hill Medical Group
City
Pacific Palisades
State/Province
California
ZIP/Postal Code
90272
Country
United States
Facility Name
Genesis Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Women's Health Care, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Clinical Trial Center of Colorado
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Clinical Trial Center of Colorado
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Clinical Physiology Associates, Inc.
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
New Age Medical Research Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Insignia Care for Women, P.A.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Mount Vernon Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta West Women's Center
City
Douglasville
State/Province
Georgia
ZIP/Postal Code
30134
Country
United States
Facility Name
Women's Health Practice
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Physicians Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Eastern Carolina Women's Center
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Hawthorne Medical Research, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Womens Medical Center
City
Bismark
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Reproductive Medical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Rapid Medical Research Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Women's Health Care Group of PA
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
South Carolina Clinical Research Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Brown Clinic, P.L.L.P.
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
New South Medical
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
Advanced Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Obstetrical & Gynecological Associates, PA
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
National Clinical Research, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
North Spokane Women's Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Dr. John Lenihan, MD
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Maritimes Research Center
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4X7
Country
Canada
Facility Name
Total Concept Health Care Inc.
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2C 2N9
Country
Canada
Facility Name
Prime Health Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4S 1Y2
Country
Canada
Facility Name
Centre d'étude clinique de Montréal Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1P6
Country
Canada
Facility Name
Les Gynecologues Associes
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
Facility Name
Clinique de Gynecologie
City
Shawinigan
State/Province
Quebec
ZIP/Postal Code
G9N 2H6
Country
Canada
Facility Name
Q & T Research, Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4J6
Country
Canada
Facility Name
Clinique Médicale des Campus
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Clinique Recherche en Sante des Femmes Inc.
City
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada

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
21422847
Citation
Jensen JT, Parke S, Mellinger U, Machlitt A, Fraser IS. Effective treatment of heavy menstrual bleeding with estradiol valerate and dienogest: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):777-787. doi: 10.1097/AOG.0b013e3182118ac3.
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

Learn more about this trial

Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

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