MetrorrhagiaPhase 3NCT00293059
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
A Phase 3 study testing Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) in people with Metrorrhagia, run by Bayer at 46 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metrorrhagia
- What is being tested?
- Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 46 sitesin 2 countries
- Study dates
- Dec 2005to May 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
United States37 sites
Mount Vernon Clinical Research
Atlanta, Georgia, 30328
South Florida Medical Research
Aventura, Florida, 33180
Womens Medical Center
Bismarck, North Dakota, 58501
Women's Health Practice
Champaign, Illinois, 61820
Reproductive Medical Research
Cincinnati, Ohio, 45267
New South Medical
Clarksville, Tennessee, 37043
Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Rapid Medical Research Inc.
Cleveland, Ohio, 44122
South Carolina Clinical Research Center
Columbia, South Carolina, 29201
Advanced Research Associates
Corpus Christi, Texas, 78414
Atlanta West Women's Center
Douglasville, Georgia, 30134
Clinical Physiology Associates, Inc.
Fort Myers, Florida, 33916
Marin Endocrine Associates
Greenbrae, California, 94904
Clinical Trial Center of Colorado
Greenwood Village, Colorado, 80111
Obstetrical & Gynecological Associates, PA
Houston, Texas
Physicians Research Group
Indianapolis, Indiana, 46250
Women and Child, LPP
Lake Havasu City, Arizona, 86403
Advanced Biomedical Research of America
Las Vegas, Nevada, 89119
Clinical Trial Center of Colorado
Littleton, Colorado, 80122
Impact Clinical Trials - Los Angeles
Los Angeles, California, 90010
New Age Medical Research Corp.
Miami, Florida, 33186
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
NYU Langone Medical Center
New York, New York, 10016
Blue Hill Medical Group
Pacific Palisades, California, 90272
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114
Research Across America
Plano, Texas, 75093
Oregon Health and Science University
Portland, Oregon, 97239
Women's Health Care Group of PA
Pottstown, Pennsylvania, 19464
National Clinical Research, Inc.
Richmond, Virginia, 23294
Genesis Center for Clinical Research
San Diego, California, 92103
Medical Center for Clinical Research
San Diego, California, 92108
Women's Health Care, Inc.
San Diego, California, 92123
North Spokane Women's Clinic
Spokane, Washington, 99207
Dr. John Lenihan, MD
Tacoma, Washington, 98405
Insignia Care for Women, P.A.
Tampa, Florida, 33607
Brown Clinic, P.L.L.P.
Watertown, South Dakota, 57201
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103
Canada9 sites
Maritimes Research Center
Bathurst, New Brunswick, E2A 4X7
Total Concept Health Care Inc.
Kitchener, Ontario, N2C 2N9
Centre d'étude clinique de Montréal Inc.
Montreal, Quebec, H1T 1P6
Les Gynecologues Associes
Montreal, Quebec, H2X 1N8
Clinique Recherche en Sante des Femmes Inc.
Québec, Quebec, G1S 2L6
Clinique de Gynecologie
Shawinigan, Quebec, G9N 2H6
Q & T Research, Inc.
Sherbrooke, Quebec, J1H 4J6
Clinique Médicale des Campus
Ste-Foy, Quebec, G1V 4X7
Prime Health Research
Toronto, Ontario, M4S 1Y2
About this study
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.
The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
Read the 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.
- Conditions
- Metrorrhagia
- Being tested
- Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027), Placebo
- Keywords
- Dysfunctional Uterine Bleeding
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)Drug
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)
PlaceboDrug
Matching placebo to be taken orally daily.
| Study group | Role | What they receive |
|---|---|---|
| Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | Experimental | 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 Receives: Drug: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) |
| Placebo | Placebo comparator | Matching placebo to be taken orally daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during a time period of 90 days under treatment
Secondary outcomes (51)
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.
Measured: during a time period of 90 days under treatment
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.
Measured: during a time period of 90 days under treatment
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.
Measured: during a time period of 90 days under treatment
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.
Measured: from baseline up to treatment day 84
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.
Measured: from baseline up to treatment day 196
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.
Measured: from baseline up to treatment day 84
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.
Measured: from baseline 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 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.
Measured: Baseline and reference period of 90 days under 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
Measured: 28 days
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
Measured: 28 days
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
Measured: 28 days
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.
Measured: baseline and reference period of 90 days under 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.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: baseline and reference period of 90 days under treatment
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.
Measured: baseline and reference period of 90 days 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.
Measured: baseline and reference period of 90 days under 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.
Measured: baseline and treatment day 84
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.
Measured: baseline and treatment day 196
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.
Measured: baseline and treatment day 84
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.
Measured: baseline and treatment day 196
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.
Measured: baseline and treatment day 84
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.
Measured: baseline 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. 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.
Measured: baseline 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. 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.
Measured: baseline and treatment day 196
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.
Measured: treatment day 84
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.
Measured: treatment day 84
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.
Measured: treatment day 84
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.
Measured: treatment day 84
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.
Measured: treatment day 84
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.
Measured: treatment day 84
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.
Measured: treatment day 84
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.
Measured: treatment day 84
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.
Measured: treatment day 84
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.
Measured: treatment day 84
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.
Measured: treatment day 196
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.
Measured: treatment day 196
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.
Measured: treatment day 196
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.
Measured: treatment day 196
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.
Measured: treatment day 196
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.
Measured: treatment day 196
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.
Measured: treatment day 196
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.
Measured: treatment day 196
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.
Measured: treatment day 196
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.
Measured: treatment day 196
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.
Measured: baseline and 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.
Measured: baseline and 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.
Measured: baseline and 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.
Measured: baseline 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.
Measured: baseline and treatment day 196
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MetrorrhagiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293059
- Sponsor's protocol ID
- 91469
- Other IDs
- 308960
- Status last verified
- Nov 2013
- First submitted
- 15 Feb 2006
- Last updated
- 27 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22240178Jensen 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.
PubMed 21422847Fraser 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.
PubMed 21774563
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00293059
- Acronym / sponsor ID
- 91469
- Conditions
- Metrorrhagia
- Keywords
- Dysfunctional Uterine Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Feb 2006 (estimated)
- Results
- Posted 6 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | Experimental | Drug: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)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 |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo to be taken orally daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)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) | Drug | Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) |
| PlaceboMatching placebo to be taken orally daily. | Drug | Placebo |
Primary outcome
Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms
Time frame: during a time period of 90 days under treatment
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.
51 secondary outcomes
Proportion of Participants Cured From Prolonged Bleeding
Time frame: during a time period of 90 days under treatment
Proportion of Participants Cured From Frequent Bleeding
Time frame: during a time period of 90 days under treatment
Proportion of Participants Cured From Excessive Bleeding
Time frame: during a time period of 90 days under treatment
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84
Time frame: from baseline up to treatment day 84
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196
Time frame: from baseline up to treatment day 196
Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84
Time frame: from baseline up to treatment day 84
Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196
Time frame: from baseline up to treatment day 196
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
Menstrual Blood Loss Volume for All Participants at Cycle 1
Time frame: 28 days
Menstrual Blood Loss Volume for All Participants at Cycle 3
Time frame: 28 days
Menstrual Blood Loss Volume for All Participants at Cycle 7
Time frame: 28 days
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
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1
Time frame: 28 days
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3
Time frame: 28 days
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7
Time frame: 28 days
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
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
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
Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84
Time frame: baseline and treatment day 84
Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196
Time frame: baseline and treatment day 196
Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84
Time frame: baseline and treatment day 84
Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196
Time frame: baseline and treatment day 196
Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84
Time frame: baseline and treatment day 84
Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196
Time frame: baseline and treatment day 196
Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84
Time frame: baseline and treatment day 84
Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196
Time frame: baseline and treatment day 196
Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84
Time frame: treatment day 84
Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84
Time frame: treatment day 84
Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84
Time frame: treatment day 84
Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84
Time frame: treatment day 84
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84
Time frame: treatment day 84
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84
Time frame: treatment day 84
Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84
Time frame: treatment day 84
Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84
Time frame: treatment day 84
Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84
Time frame: treatment day 84
Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84
Time frame: treatment day 84
Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196
Time frame: treatment day 196
Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196
Time frame: treatment day 196
Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196
Time frame: treatment day 196
Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196
Time frame: treatment day 196
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22240178Fraser 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 publication: PubMed 21422847Jensen 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 publication: PubMed 21774563Fraser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) in people with Metrorrhagia, run by Bayer at 46 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms (time frame: during a time period of 90 days under treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00293059, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013.