Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ

PHASE3CompletedINTERVENTIONAL
Enrollment

1,887

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
ContraceptionOvulation InhibitionContraceptives, Oral
Interventions
DRUG

EE20/DRSP (BAY86-5300)

Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone

DRUG

EE20/DRSP (BAY86-5300)

Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone

DRUG

EE20/DRSP (YAZ, BAY86-5300)

Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)

Trial Locations (85)

14618

Rochester

15206

Pittsburgh

19046

Jenkintown

19114

Philadelphia

23233

Richmond

23294

Richmond

27103

Winston-Salem

27713

Durham

28562

New Bern

29201

Columbia

29464

Mt. Pleasant

30034

Decatur

30328

Atlanta

32259

Jacksonville

33024

Pembroke Pines

33134

Coral Gables

33143

South Miami

33161

North Miami

33186

Miami

33313

Plantation

33409

West Palm Beach

33461

Lake Worth

33709

St. Petersburg

33759

Clearwater

34102

Naples

34429

Crystal River

34613

Brooksville

36116

Montgomery

37203

Nashville

37404

Chattanooga

37920

Knoxville

38120

Memphis

40509

Lexington

43213

Columbus

44122

Cleveland

47630

Newburgh

49079

Paw Paw

58501

Bismarck

60612

Chicago

61820

Champaign

63017

Chesterfield

64114

Kansas City

67207

Wichita

68510

Lincoln

70072

Marrero

73112

Oklahoma City

75234

Dallas

76034

Colleyville

77054

Houston

77074

Houston

78414

Corpus Christi

80111

Greenwood Village

80123

Littleton

80218

Denver

80909

Colorado Springs

83404

Idaho Falls

83702

Boise

83704

Boise

84088

West Jordan

85031

Phoenix

85203

Mesa

85213

Mesa

85224

Chandler

85283

Tempe

85712

Tucson

85741

Tucson

89104

Las Vegas

89106

LasVegas

89109

Las Vegas

90212

Beverly Hills

90272

Pacific Palisades

92103

San Diego

92108

San Diego

92705

Santa Ana

94589

Vallejo

97239

Portland

98105

Seattle

99207

Spokane

92801-2811

Anaheim

06708

Waterbury

33472-2952

Boynton Beach

08057

Moorestown

08901

New Brunswick

97239-3011

Portland

38305-3618

Jackson

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00567164 - Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ | Biotech Hunter | Biotech Hunter