Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

PHASE3CompletedINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions
Metrorrhagia
Interventions
DRUG

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

Placebo

Matching placebo to be taken orally daily.

Trial Locations (46)

10016

NYU Langone Medical Center, New York

19114

Clinical Research of Philadelphia, LLC, Philadelphia

19464

Women's Health Care Group of PA, Pottstown

23294

National Clinical Research, Inc., Richmond

27103

Hawthorne Medical Research, Inc., Winston-Salem

28562

Eastern Carolina Women's Center, New Bern

29201

South Carolina Clinical Research Center, Columbia

30134

Atlanta West Women's Center, Douglasville

30328

Mount Vernon Clinical Research, Atlanta

33180

South Florida Medical Research, Aventura

33186

New Age Medical Research Corp., Miami

33607

Insignia Care for Women, P.A., Tampa

33759

Women's Medical Research Group, LLC, Clearwater

33916

Clinical Physiology Associates, Inc., Fort Myers

37043

New South Medical, Clarksville

44122

Rapid Medical Research Inc., Cleveland

45267

Reproductive Medical Research, Cincinnati

46250

Physicians Research Group, Indianapolis

57201

Brown Clinic, P.L.L.P., Watertown

58501

Womens Medical Center, Bismarck

61820

Women's Health Practice, Champaign

75093

Research Across America, Plano

78414

Advanced Research Associates, Corpus Christi

80111

Clinical Trial Center of Colorado, Greenwood Village

80122

Clinical Trial Center of Colorado, Littleton

86403

Women and Child, LPP, Lake Havasu City

89119

Advanced Biomedical Research of America, Las Vegas

90010

Impact Clinical Trials - Los Angeles, Los Angeles

90272

Blue Hill Medical Group, Pacific Palisades

92103

Genesis Center for Clinical Research, San Diego

92108

Medical Center for Clinical Research, San Diego

92123

Women's Health Care, Inc., San Diego

94904

Marin Endocrine Associates, Greenbrae

97239

Oregon Health and Science University, Portland

98405

Dr. John Lenihan, MD, Tacoma

99207

North Spokane Women's Clinic, Spokane

Unknown

Obstetrical & Gynecological Associates, PA, Houston

E2A 4X7

Maritimes Research Center, Bathurst

N2C 2N9

Total Concept Health Care Inc., Kitchener

M4S 1Y2

Prime Health Research, Toronto

H1T 1P6

Centre d'étude clinique de Montréal Inc., Montreal

H2X 1N8

Les Gynecologues Associes, Montreal

G1S 2L6

Clinique Recherche en Sante des Femmes Inc., Québec

G9N 2H6

Clinique de Gynecologie, Shawinigan

J1H 4J6

Q & T Research, Inc., Sherbrooke

G1V 4X7

Clinique Médicale des Campus, Ste-Foy

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00293059 - Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding | Biotech Hunter | Biotech Hunter