To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)

PHASE3CompletedINTERVENTIONAL
Enrollment

409

Participants

Timeline

Start Date

September 8, 2008

Primary Completion Date

May 10, 2011

Study Completion Date

May 10, 2011

Conditions
Contraception
Interventions
DRUG

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo

DRUG

Ortho Tri Cyclen Lo

Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo

Trial Locations (59)

19114

Philadelphia

30034

Decatur

32207

Jacksonville

33409

West Palm Beach

33759

Clearwater

37620

Bristol

38120

Memphis

43213

Columbus

45246

Cincinnati

46037

Fishers

46217

Indianapolis

46601

South Bend

54601

La Crosse

63017

Chesterfield

63141

St Louis

68510

Lincoln

70006

Metairie

77054

Houston

80127

Littleton

80206

Denver

80218

Denver

83406

Idaho Falls

83702

Boise

83712

Boise

85032

Phoenix

89128

Las Vegas

90404

Santa Monica

92024

Encinitas

92108

San Diego

94925

Independence

Winston-Salem

99207

Spokane

08901

New Brunswick

97239-3011

Portland

V3A 4H9

Langley

E2A 4Z9

Bathurst

A1A 3R5

St. John's

B3K 5R3

Halifax

N0N 1G0

Corunna

M3J 1N2

Downsview

L8L 5G8

Hamilton

L8M 1K7

Hamilton

L3Y 5G8

Newmarket

K1H 7W9

Ottawa

N7T 4X3

Sarnia

M4S 1Y2

Toronto

M9W 4L6

Toronto

N4S 5P5

Woodstock

C1A 5Y9

Charlottetown

J2B 7T1

Drummondville

J7J 2K8

Mirabel

H9R 3J1

Pointe-Claire

H9R 4S3

Pointe-Claire

G9N 2H6

Shawinigan

G1V 4X7

Ste-Foy

S4P 3X1

Regina

S7H 5M3

Saskatoon

S7K 7H9

Saskatoon

G3K 2P8

Québec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00754065 - To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada) | Biotech Hunter | Biotech Hunter