Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
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.
2 other identifiers
interventional
190
2 countries
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2005
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 15, 2006
CompletedFirst Posted
Study publicly available on registry
February 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
June 6, 2011
CompletedNovember 27, 2013
November 1, 2013
2.4 years
February 15, 2006
February 23, 2011
November 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
during a time period of 90 days under treatment
Secondary Outcomes (51)
Proportion of Participants Cured From Prolonged Bleeding
during a time period of 90 days under treatment
Proportion of Participants Cured From Frequent Bleeding
during a time period of 90 days under treatment
Proportion of Participants Cured From Excessive Bleeding
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
from baseline up to treatment day 84
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196
from baseline up to treatment day 196
- +46 more secondary outcomes
Study Arms (2)
Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
EXPERIMENTALA 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 COMPARATORMatching placebo to be taken orally daily
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (46)
Women and Child, LPP
Lake Havasu City, Arizona, 86403, United States
Marin Endocrine Associates
Greenbrae, California, 94904, United States
Impact Clinical Trials - Los Angeles
Los Angeles, California, 90010, United States
Blue Hill Medical Group
Pacific Palisades, California, 90272, United States
Genesis Center for Clinical Research
San Diego, California, 92103, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Women's Health Care, Inc.
San Diego, California, 92123, United States
Clinical Trial Center of Colorado
Greenwood Village, Colorado, 80111, United States
Clinical Trial Center of Colorado
Littleton, Colorado, 80122, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Women's Medical Research Group, LLC
Clearwater, Florida, 33759, United States
Clinical Physiology Associates, Inc.
Fort Myers, Florida, 33916, United States
New Age Medical Research Corp.
Miami, Florida, 33186, United States
Insignia Care for Women, P.A.
Tampa, Florida, 33607, United States
Mount Vernon Clinical Research
Atlanta, Georgia, 30328, United States
Atlanta West Women's Center
Douglasville, Georgia, 30134, United States
Women's Health Practice
Champaign, Illinois, 61820, United States
Physicians Research Group
Indianapolis, Indiana, 46250, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89119, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Eastern Carolina Women's Center
New Bern, North Carolina, 28562, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103, United States
Womens Medical Center
Bismarck, North Dakota, 58501, United States
Reproductive Medical Research
Cincinnati, Ohio, 45267, United States
Rapid Medical Research Inc.
Cleveland, Ohio, 44122, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
Women's Health Care Group of PA
Pottstown, Pennsylvania, 19464, United States
South Carolina Clinical Research Center
Columbia, South Carolina, 29201, United States
Brown Clinic, P.L.L.P.
Watertown, South Dakota, 57201, United States
New South Medical
Clarksville, Tennessee, 37043, United States
Advanced Research Associates
Corpus Christi, Texas, 78414, United States
Obstetrical & Gynecological Associates, PA
Houston, Texas, United States
Research Across America
Plano, Texas, 75093, United States
National Clinical Research, Inc.
Richmond, Virginia, 23294, United States
North Spokane Women's Clinic
Spokane, Washington, 99207, United States
Dr. John Lenihan, MD
Tacoma, Washington, 98405, United States
Maritimes Research Center
Bathurst, New Brunswick, E2A 4X7, Canada
Total Concept Health Care Inc.
Kitchener, Ontario, N2C 2N9, Canada
Prime Health Research
Toronto, Ontario, M4S 1Y2, Canada
Centre d'étude clinique de Montréal Inc.
Montreal, Quebec, H1T 1P6, Canada
Les Gynecologues Associes
Montreal, Quebec, H2X 1N8, Canada
Clinique Recherche en Sante des Femmes Inc.
Québec, Quebec, G1S 2L6, Canada
Clinique de Gynecologie
Shawinigan, Quebec, G9N 2H6, Canada
Q & T Research, Inc.
Sherbrooke, Quebec, J1H 4J6, Canada
Clinique Médicale des Campus
Ste-Foy, Quebec, G1V 4X7, Canada
Related Publications (3)
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.
PMID: 22240178RESULTJensen 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.
PMID: 21422847RESULTFraser 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.
PMID: 21774563RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2006
First Posted
February 17, 2006
Study Start
December 1, 2005
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
November 27, 2013
Results First Posted
June 6, 2011
Record last verified: 2013-11