Clinical trial NCT00293059: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metrorrhagia
Keywords: Dysfunctional Uterine Bleeding
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-02-17
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms
timeFrame: during a time period of 90 days under treatment
Secondary outcomes:
measure: Proportion of Participants Cured From Prolonged Bleeding
timeFrame: during a time period of 90 days under treatment
measure: Proportion of Participants Cured From Frequent Bleeding
timeFrame: during a time period of 90 days under treatment
measure: Proportion of Participants Cured From Excessive Bleeding
timeFrame: during a time period of 90 days under treatment
measure: Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84
timeFrame: from baseline up to treatment day 84
measure: Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196
timeFrame: from baseline up to treatment day 196
measure: Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84
timeFrame: from baseline up to treatment day 84
measure: Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196
timeFrame: from baseline up to treatment day 196
measure: Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment
timeFrame: Baseline and reference period of 90 days under treatment
measure: Menstrual Blood Loss Volume for All Participants at Cycle 1
timeFrame: 28 days
measure: Menstrual Blood Loss Volume for All Participants at Cycle 3
timeFrame: 28 days
measure: Menstrual Blood Loss Volume for All Participants at Cycle 7
timeFrame: 28 days
measure: Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment
timeFrame: baseline and reference period of 90 days under treatment
measure: Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1
timeFrame: 28 days
measure: Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3
timeFrame: 28 days
measure: Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7
timeFrame: 28 days
measure: Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment
timeFrame: baseline and reference period of 90 days under treatment
measure: Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment
timeFrame: baseline and reference period of 90 days under treatment
measure: Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment
timeFrame: baseline and reference period of 90 days under treatment
measure: Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84
timeFrame: baseline and treatment day 84
measure: Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196
timeFrame: baseline and treatment day 196
measure: Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84
timeFrame: baseline and treatment day 84
measure: Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196
timeFrame: baseline and treatment day 196
measure: Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84
timeFrame: baseline and treatment day 84
measure: Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196
timeFrame: baseline and treatment day 196
measure: Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84
timeFrame: baseline and treatment day 84
measure: Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196
timeFrame: baseline and treatment day 196
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84
timeFrame: treatment day 84
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84
timeFrame: treatment day 84
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84
timeFrame: treatment day 84
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84
timeFrame: treatment day 84
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84
timeFrame: treatment day 84
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84
timeFrame: treatment day 84
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84
timeFrame: treatment day 84
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84
timeFrame: treatment day 84
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84
timeFrame: treatment day 84
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84
timeFrame: treatment day 84
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196
timeFrame: treatment day 196
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196
timeFrame: treatment day 196
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196
timeFrame: treatment day 196
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196
timeFrame: treatment day 196
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196
timeFrame: treatment day 196
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196
timeFrame: treatment day 196
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196
timeFrame: treatment day 196
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196
timeFrame: treatment day 196
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196
timeFrame: treatment day 196
measure: Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196
timeFrame: treatment day 196
measure: Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 196
timeFrame: baseline and treatment day 196
measure: Change From Baseline in Serum Ferritin Concentration at Treatment Day 84
timeFrame: baseline and treatment day 84
measure: Change From Baseline in Serum Ferritin Concentration at Treatment Day 196
timeFrame: baseline and treatment day 196
measure: Change From Baseline in Hemoglobin Concentration at Treatment Day 84
timeFrame: baseline and treatment day 84
measure: Change From Baseline in Hemoglobin Concentration at Treatment Day 196
timeFrame: baseline and treatment day 196
Other outcomes:
Locations:
city: Lake Havasu CIty
country: United States
facility: Women and Child, LPP
state: Arizona
city: Greenbrae
country: United States
facility: Marin Endocrine Associates
state: California
city: Los Angeles
country: United States
facility: Impact Clinical Trials - Los Angeles
state: California
city: Pacific Palisades
country: United States
facility: Blue Hill Medical Group
state: California
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Women's Health Care, Inc.
state: California
city: Greenwood Village
country: United States
facility: Clinical Trial Center of Colorado
state: Colorado
city: Littleton
country: United States
facility: Clinical Trial Center of Colorado
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates, Inc.
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corp.
state: Florida
city: Tampa
country: United States
facility: Insignia Care for Women, P.A.
state: Florida
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Douglasville
country: United States
facility: Atlanta West Women's Center
state: Georgia
city: Champaign
country: United States
facility: Women's Health Practice
state: Illinois
city: Indianapolis
country: United States
facility: Physicians Research Group
state: Indiana
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: Bismark
country: United States
facility: Womens Medical Center
state: North Dakota
city: Cincinnati
country: United States
facility: Reproductive Medical Research
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Pottstown
country: United States
facility: Women's Health Care Group of PA
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Clinical Research Center
state: South Carolina
city: Watertown
country: United States
facility: Brown Clinic, P.L.L.P.
state: South Dakota
city: Clarksville
country: United States
facility: New South Medical
state: Tennessee
city: Corpus Christi
country: United States
facility: Advanced Research Associates
state: Texas
city: Houston
country: United States
facility: Obstetrical & Gynecological Associates, PA
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: Richmond
country: United States
facility: National Clinical Research, Inc.
state: Virginia
city: Spokane
country: United States
facility: North Spokane Women's Clinic
state: Washington
city: Tacoma
country: United States
facility: Dr. John Lenihan, MD
state: Washington
city: Bathurst
country: Canada
facility: Maritimes Research Center
state: New Brunswick
city: Kitchener
country: Canada
facility: Total Concept Health Care Inc.
state: Ontario
city: Toronto
country: Canada
facility: Prime Health Research
state: Ontario
city: Montreal
country: Canada
facility: Centre d'étude clinique de Montréal Inc.
state: Quebec
city: Montreal
country: Canada
facility: Les Gynecologues Associes
state: Quebec
city: Shawinigan
country: Canada
facility: Clinique de Gynecologie
state: Quebec
city: Sherbrooke
country: Canada
facility: Q & T Research, Inc.
state: Quebec
city: Ste-Foy
country: Canada
facility: Clinique Médicale des Campus
state: Quebec
city: Quebec
country: Canada
facility: Clinique Recherche en Sante des Femmes Inc.
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.
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.
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.