190
Participants
Start Date
December 31, 2005
Primary Completion Date
May 31, 2008
Study Completion Date
May 31, 2008
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.
NYU Langone Medical Center, New York
Clinical Research of Philadelphia, LLC, Philadelphia
Women's Health Care Group of PA, Pottstown
National Clinical Research, Inc., Richmond
Hawthorne Medical Research, Inc., Winston-Salem
Eastern Carolina Women's Center, New Bern
South Carolina Clinical Research Center, Columbia
Atlanta West Women's Center, Douglasville
Mount Vernon Clinical Research, Atlanta
South Florida Medical Research, Aventura
New Age Medical Research Corp., Miami
Insignia Care for Women, P.A., Tampa
Women's Medical Research Group, LLC, Clearwater
Clinical Physiology Associates, Inc., Fort Myers
New South Medical, Clarksville
Rapid Medical Research Inc., Cleveland
Reproductive Medical Research, Cincinnati
Physicians Research Group, Indianapolis
Brown Clinic, P.L.L.P., Watertown
Womens Medical Center, Bismarck
Women's Health Practice, Champaign
Research Across America, Plano
Advanced Research Associates, Corpus Christi
Clinical Trial Center of Colorado, Greenwood Village
Clinical Trial Center of Colorado, Littleton
Women and Child, LPP, Lake Havasu City
Advanced Biomedical Research of America, Las Vegas
Impact Clinical Trials - Los Angeles, Los Angeles
Blue Hill Medical Group, Pacific Palisades
Genesis Center for Clinical Research, San Diego
Medical Center for Clinical Research, San Diego
Women's Health Care, Inc., San Diego
Marin Endocrine Associates, Greenbrae
Oregon Health and Science University, Portland
Dr. John Lenihan, MD, Tacoma
North Spokane Women's Clinic, Spokane
Obstetrical & Gynecological Associates, PA, Houston
Maritimes Research Center, Bathurst
Total Concept Health Care Inc., Kitchener
Prime Health Research, Toronto
Centre d'étude clinique de Montréal Inc., Montreal
Les Gynecologues Associes, Montreal
Clinique Recherche en Sante des Femmes Inc., Québec
Clinique de Gynecologie, Shawinigan
Q & T Research, Inc., Sherbrooke
Clinique Médicale des Campus, Ste-Foy
Lead Sponsor
Bayer
INDUSTRY