Study Completed

Menorrhagia

Bayer Identifier:

91518

ClinicalTrials.gov Identifier:

NCT00360490

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study in women with Idiopathic Menorrhagia to determine the reduction in menstrual blood loss (MBL) after treatment with the levonorgestrel-releasing intrauterine system (IUS)

Trial purpose

The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.

Key Participants Requirements

Sex

Female

Age

18 Years

Trial summary

Enrollment Goal

165

Trial Dates

July 2006 - June 2008

Phase

Phase 3

Could I Receive a placebo

Products

Mirena (Levonorgestrel IUS, BAY86-5028)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Eastern Virginia Medical School	Norfolk, 23507, United States
Completed	Northern Indiana Womens Heatlh Research, Inc.	South Bend, 46601, United States
Completed	Boston University School of Medicine	Boston, 02118, United States
Completed	Genesis Center for Clinical Research	San Diego, 92103, United States
Completed	Visions Clinical Research - Tucson	Tucson, 85712, United States
Completed	Oregon Health and Science University	Portland, 97239, United States
Completed	Fletcher Allen Health Care	Burlington, 05401, United States
Completed	University of Florida Women's Health- Specialists Emerson	Jacksonville, 32216, United States
Completed	South Carolina Clinical Research Center	Columbia, 29201, United States
Completed	Harbor - UCLA Medical Center	Torrance, 90509, United States
Completed	Advances in Health, inc.	Houston, 77030, United States
Terminated	Synergy Medical Education Alliance	Saginaw, 48602, United States
Completed	Lyndhurst Gynecologic Associates	Winston-Salem, 27103, United States
Completed	Clinical Research of Philadelphia, LLC	Philadelphia, 19114, United States
Completed	Comprehensive Clinical Trials	West Palm Beach, 33409, United States
Completed	Visions Clinical Research	Boynton Beach, 33437, United States
Completed	University of Medicine and Dentistry of New Jersey	New Brunswick, 08901, United States
Terminated	Laurel Creek Research Associates	Moorestown, 08057, United States
Completed	Seattle Women's: Health, Research, Gynecology	Seattle, 98105, United States
Completed	York Clinical Consulting	Marrero, 70072, United States
Terminated	Woman’s Clinical Research	Newburgh, 47630, United States
Completed	Clinical Trials Research Services, LLC	Pittsburgh, 15206, United States
Completed	Blue Hill Medical Group	Santa Monica, 90403, United States
Completed	Medical Center for Clinical Research	San Diego, 92108, United States
Completed	Phoenix Ob-Gyn Assoicates	Moorestown, 08057, United States
Completed	Center for Women's Research	Chicago, 60612, United States
Completed	Women's Clinic of Lincoln, PC	Lincoln, 68510, United States
Completed	Impact Clinical Trials	Beverly Hills, 90211, United States
Completed	Yassear Clinical Research	Carmichael, 95608, United States
Completed	Clinical Trial Center of Colorado	Littleton, 80122, United States
Completed	New South Medical	Clarksville, 37043, United States
Completed	Affiliated Clinical Research, Inc.	Las Vegas, United States
Completed	York Clinical Consulting	Amite, 70422, United States
Terminated	Obstetrical & Gynecological Associates, PA	Houston, United States
Completed	St. Louis Women's Health Care Group	Chesterfield, 63017, United States
Completed	Providence Medical Group/OB-GYN Health Center	Medford, 97504, United States
Completed	Research Associates	Boise, 83702, United States
Completed	Affiliated Clinical Research, Inc.	LasVegas, 89106, United States
Completed	Clinique de Gynecologie	Shawinigan, G9N 2H6, Canada
Completed	Ottawa Hospital-Riverside Campus	Ottawa, K1H7W9, Canada
Completed	Clinique Recherche en Sante des Femmes Inc.	Quebec, G1S 2L6, Canada
Completed	Centre d'étude clinique de Montréal Inc.	Montreal, H1T 1P6, Canada
Completed	Prime Health Research	Toronto, M4S 1Y2, Canada
Completed	Kells Medical Research Group, Inc.	Pointe-Claire, H9R 4S3, Canada
Completed	Centre for Kinesiology, Health and Sport	Regina, S4S 0A2, Canada
Completed	Les Gynecologues Associes	Montreal, H2X 1N8, Canada
Completed	Maritimes Research Center	Bathurst, E2A 4X7, Canada
Completed	Omnispec Recherche Clinique Inc.	Mirabel, J7J 1L2, Canada
Completed	Faculdade de Ciencias Medicas-Universidade Estadual Campinas	Campinas, 13083-970, Brazil
Completed	Centro de Estudos e Pesquisas em Reproducao Humana e Fertil.	Curitiba, 80030-220, Brazil
Terminated	Hospital Italiano Buenos Aires	Buenos Aires, C1181ACH, Argentina
Completed	Hospital Bernardino Rivadavia	Buenos Aires, 1425, Argentina
Completed	Hospital General de México SS	Mexico, 16720, Mexico
Completed	Hospital Universitario "José Eleuterio González"	Monterrey, 64460, Mexico
Completed	Instituto Nacional de Perinatología	MEXICO DF, 11000, Mexico

Primary Outcome

The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)
Time Frame:
Baseline and up to 6 months
Safety Issue:
No
Percentage of Patients With Successful Treatment
Time Frame:
At 6 months
Safety Issue:
No

Secondary Outcome

Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
Time Frame:
Baseline and up to 6 months
Safety Issue:
No
Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)
Time Frame:
Baseline and up to 3 months
Safety Issue:
No
Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
Time Frame:
Baseline and up to 3 months
Safety Issue:
No
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
Time Frame:
Baseline and up to 6 months
Safety Issue:
No
Total Number of Bleeding Days
Time Frame:
Baseline and up to 6 months
Safety Issue:
No
Total Number of Spotting and Bleeding Days
Time Frame:
Baseline and up to 6 months
Safety Issue:
No
Total Number of Spotting Days
Time Frame:
Baseline and up to 6 months
Safety Issue:
No
Total Number of Bleeding Episodes
Time Frame:
Baseline and up to 6 months
Safety Issue:
No
Percent Change in Hemoglobin
Time Frame:
Baseline and up to 6 months
Safety Issue:
No
Percent Change in Hematocrit
Time Frame:
Baseline and up to 6 months
Safety Issue:
No
Percent Change in Serum Ferritin
Time Frame:
Baseline and up to 6 months
Safety Issue:
No
Percentage of Patients With Improvement in the Investigator Global Assessment Scale
Time Frame:
Up to 6 months
Safety Issue:
No
Percentage of Patients With Improvement in the Patients Overall Assessment Scale
Time Frame:
Up to 6 months
Safety Issue:
No

Trial design

A Multicenter, Randomized, Open label, Parallel Group, Active Control Study to Evaluate the Efficacy and Safety of LNG IUS (Mirena®) as Compared to Medroxyprogesterone Acetate During 6 Cycles of Treatment in Patients with Idiopathic Menorrhagia

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.