Endometrial Safety Study

PHASE3CompletedINTERVENTIONAL
Enrollment

662

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

August 31, 2009

Study Completion Date

August 31, 2009

Conditions
Postmenopause
Interventions
DRUG

0.25mg DRSP / 0.5mg E2 (BAY86-4891)

One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle).

DRUG

0.5mg NETA / 1.0mg E2 (Activella)

One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).

Trial Locations (59)

1030

Vienna

1060

Vienna

1090

Vienna

1200

Vienna

1824

Lanús Oeste

2340

Mödling

2700

Wiener Neustadt

2750

Ballerup Municipality

3100

Sankt Pölten

6020

Innsbruck

6300

Wörgl

6900

Bregenz

7100

Vejle

8280

Fürstenfeld

8680

Mürzzuschlag

8740

Zeltweg

9000

Aalborg

9020

Klagenfurt

14050

México, D.F.

19114

Philadelphia

23294

Richmond

28100

Novara

29201

Columbia

33437

Boynton Beach

33759

Clearwater

40138

Bologna

41124

Modena

43100

Parma

44122

Cleveland

53100

Siena

56126

Pisa

64460

Monterrey

70072

Marrero

70422

Amite

78414

Corpus Christi

80111

Greenwood Village

80218

Denver

83704

Boise

85224

Chandler

89122

Las Vegas

92103

San Diego

92108

San Diego

98105

Seattle

101000

Moskva

113093

Moskva

117415

Moscow

117997

Moskva

177997

Moscow

B1642CLN

San Isidro

C1117ABH

Buenos Aires

C1280AEB

Buenos Aires

74175-080

Goiânia

80030-220

Curitiba

90035-001

Porto Alegre

04062-003

São Paulo

09124

Cagliari

07100

Sassari

Unknown

Mexico City

06700

México

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Laboratorium für Klinische Forschung

UNKNOWN

collaborator

Diagnostic Cytology Laboratory

UNKNOWN

collaborator

University of California, San Francisco

OTHER

lead

Bayer

INDUSTRY

NCT00522873 - Endometrial Safety Study | Biotech Hunter | Biotech Hunter