Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
NCT ID: NCT00293059
Last Updated: 2013-11-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
190 participants
INTERVENTIONAL
2005-12-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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)
Placebo
Matching placebo to be taken orally daily
Placebo
Matching placebo to be taken orally daily.
Interventions
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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)
Placebo
Matching placebo to be taken orally daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* Women with history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Women and Child, LPP
Lake Havasu City, Arizona, United States
Marin Endocrine Associates
Greenbrae, California, United States
Impact Clinical Trials - Los Angeles
Los Angeles, California, United States
Blue Hill Medical Group
Pacific Palisades, California, United States
Genesis Center for Clinical Research
San Diego, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Women's Health Care, Inc.
San Diego, California, United States
Clinical Trial Center of Colorado
Greenwood Village, Colorado, United States
Clinical Trial Center of Colorado
Littleton, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
Clinical Physiology Associates, Inc.
Fort Myers, Florida, United States
New Age Medical Research Corp.
Miami, Florida, United States
Insignia Care for Women, P.A.
Tampa, Florida, United States
Mount Vernon Clinical Research
Atlanta, Georgia, United States
Atlanta West Women's Center
Douglasville, Georgia, United States
Women's Health Practice
Champaign, Illinois, United States
Physicians Research Group
Indianapolis, Indiana, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
NYU Langone Medical Center
New York, New York, United States
Eastern Carolina Women's Center
New Bern, North Carolina, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, United States
Womens Medical Center
Bismarck, North Dakota, United States
Reproductive Medical Research
Cincinnati, Ohio, United States
Rapid Medical Research Inc.
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States
Women's Health Care Group of PA
Pottstown, Pennsylvania, United States
South Carolina Clinical Research Center
Columbia, South Carolina, United States
Brown Clinic, P.L.L.P.
Watertown, South Dakota, United States
New South Medical
Clarksville, Tennessee, United States
Advanced Research Associates
Corpus Christi, Texas, United States
Obstetrical & Gynecological Associates, PA
Houston, Texas, United States
Research Across America
Plano, Texas, United States
National Clinical Research, Inc.
Richmond, Virginia, United States
North Spokane Women's Clinic
Spokane, Washington, United States
Dr. John Lenihan, MD
Tacoma, Washington, United States
Maritimes Research Center
Bathurst, New Brunswick, Canada
Total Concept Health Care Inc.
Kitchener, Ontario, Canada
Prime Health Research
Toronto, Ontario, Canada
Centre d'étude clinique de Montréal Inc.
Montreal, Quebec, Canada
Les Gynecologues Associes
Montreal, Quebec, Canada
Clinique Recherche en Sante des Femmes Inc.
Québec, Quebec, Canada
Clinique de Gynecologie
Shawinigan, Quebec, Canada
Q & T Research, Inc.
Sherbrooke, Quebec, Canada
Clinique Médicale des Campus
Ste-Foy, Quebec, Canada
Countries
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References
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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.
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.
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.
Other Identifiers
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308960
Identifier Type: OTHER
Identifier Source: secondary_id
91469
Identifier Type: -
Identifier Source: org_study_id