Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)

PHASE3CompletedINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Menorrhagia
Interventions
DRUG

Levonorgestrel IUS (Mirena, BAY86-5028)

Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.

DRUG

Medroxyprogesterone acetate

Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Trial Locations (54)

1425

Buenos Aires

11000

Mexico City

15206

Pittsburgh

16720

México

19114

Philadelphia

23507

Norfolk

27103

Winston-Salem

29201

Columbia

32216

Jacksonville

33409

West Palm Beach

33437

Boynton Beach

37043

Clarksville

46601

South Bend

47630

Newburgh

48602

Saginaw

60612

Chicago

63017

Chesterfield

64460

Monterrey

68510

Lincoln

70072

Marrero

70422

Amite

77030

Houston

80122

Littleton

83702

Boise

85712

Tucson

89106

LasVegas

90211

Beverly Hills

90403

Santa Monica

90509

Torrance

92103

San Diego

92108

San Diego

95608

Carmichael

97239

Portland

97504

Medford

98105

Seattle

02118

Boston

Unknown

Las Vegas

Houston

08057

Moorestown

08901

New Brunswick

05401

Burlington

C1181ACH

Buenos Aires

80030-220

Curitiba

13083-970

Campinas

E2A 4X7

Bathurst

K1H7W9

Ottawa

M4S 1Y2

Toronto

J7J 1L2

Mirabel

H1T 1P6

Montreal

H2X 1N8

Montreal

H9R 4S3

Pointe-Claire

G1S 2L6

Québec

G9N 2H6

Shawinigan

S4S 0A2

Regina

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY