Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

PHASE3CompletedINTERVENTIONAL
Enrollment

735

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

October 31, 2008

Study Completion Date

November 30, 2008

Conditions
Vasomotor SymptomsHot Flashes
Interventions
DRUG

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

One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).

DRUG

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

One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).

DRUG

Estradiol (E2 0.3mg)

One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).

DRUG

Placebo

Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Trial Locations (76)

15090

Wexford

15206

Pittsburgh

16502

Erie

19114

Philadelphia

23294

Richmond

23507

Norfolk

27103

Winston-Salem

27612

Raleigh

29201

Columbia

30034

Decatur

30328

Atlanta

30342

Atlanta

32114

Daytona Beach

32216

Jacksonville

33169

Miami

33186

Miami

33409

West Palm Beach

33437

Boynton Beach

33461

Lake Worth

33607

Tampa

33761

Clearwater

33916

Fort Myers

34655

New Port Richey

34748

Leesburg

36608

Mobile

37403

Chattanooga

37404

Chattanooga

38120

Memphis

40536

Lexington

43213

Columbus

44122

Cleveland

47630

Newburgh

49079

Paw Paw

55318

Chaska

57105

Sioux Falls

58105

Fargo

59101

Billings

59102

Billings

60004

Arlington Heights

60526

La Grange Park

61820

Champaign

65802

Springfield

68510

Lincoln

70072

Marrero

70422

Amite

72205

Little Rock

73103

Oklahoma City

74105

Tulsa

75234

Dallas

77004

Houston

77030

Houston

80218

Denver

80910

Colorado Springs

83404

Idaho Falls

83702

Boise

85031

Phoenix

85225

Chandler

85712

Tucson

85741

Tucson

87102

Albuquerque

89104

Las Vegas

89502

Reno

90723

Paramount

91607

Valley Village

92083

Vista

92103

San Diego

92108

San Diego

92121

San Diego

92123

San Diego

98055

Renton

98105

Seattle

06050

New Britain

08648

Lawrenceville

08901

New Brunswick

08540

Princeton

05401

Burlington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY