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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menorrhagia

Intervention: Levonorgestrel IUS (Mirena, BAY86-5028) (Drug); Medroxyprogesterone acetate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)

Percentage of Patients With Successful Treatment

Secondary outcome:

Percent Change From Baseline MBL to End of Study MBL (Cycle 6)

Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)

Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)

Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group

Total Number of Bleeding Days

Total Number of Spotting and Bleeding Days

Total Number of Spotting Days

Total Number of Bleeding Episodes

Percent Change in Hemoglobin

Percent Change in Hematocrit

Percent Change in Serum Ferritin

Percentage of Patients With Improvement in the Investigator Global Assessment Scale

Percentage of Patients With Improvement in the Patients Overall Assessment Scale

Detailed description: Acronyms in the Adverse Event Section:

- IUCD Intrauterine Contraceptive Device

- MedDRA Medical Dictionary for Regulatory Activities

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer HealthCare AG, Germany.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women who have >/= 80 mL blood loss during their menstrual cycles and desire

contraception Exclusion Criteria:

- Post menopausal menstrual cycle < 21 days or > 35 days

- Pregnancy

Locations and Contacts

Buenos Aires 1425, Argentina

Buenos Aires C1181ACH, Argentina

Quebec G1S 2L6, Canada

Mexico Df 11000, Mexico

Tucson, Arizona 85712, United States

Beverly Hills, California 90211, United States

Carmichael, California 95608, United States

San Diego, California 92103, United States

San Diego, California 92108, United States

Santa Monica, California 90403, United States

Torrance, California 90509, United States

Littleton, Colorado 80122, United States

Boynton Beach, Florida 33437, United States

Jacksonville, Florida 32216, United States

West Palm Beach, Florida 33409, United States

Boise, Idaho 83702, United States

Chicago, Illinois 60612, United States

Newburgh, Indiana 47630, United States

South Bend, Indiana 46601, United States

Amite, Louisiana 70422, United States

Marrero, Louisiana 70072, United States

Boston, Massachusetts 02118, United States

Saginaw, Michigan 48602, United States

Chesterfield, Missouri 63017, United States

Mexico, México 16720, Mexico

Lincoln, Nebraska 68510, United States

Las Vegas, Nevada, United States

LasVegas, Nevada 89106, United States

Bathurst, New Brunswick E2A 4X7, Canada

Moorestown, New Jersey 08057, United States

New Brunswick, New Jersey 08901, United States

Winston-Salem, North Carolina 27103, United States

Monterrey, Nuevo Leon 64460, Mexico

Ottawa, Ontario K1H7W9, Canada

Toronto, Ontario M4S 1Y2, Canada

Medford, Oregon 97504, United States

Portland, Oregon 97239, United States

Curitiba, Parana 80030-220, Brazil

Philadelphia, Pennsylvania 19114, United States

Pittsburgh, Pennsylvania 15206, United States

Mirabel, Quebec J7J 1L2, Canada

Montreal, Quebec H1T 1P6, Canada

Montreal, Quebec H2X 1N8, Canada

Pointe-Claire, Quebec H9R 4S3, Canada

Shawinigan, Quebec G9N 2H6, Canada

Campinas, Sao Paulo 13083-970, Brazil

Regina, Saskatchewan S4S 0A2, Canada

Columbia, South Carolina 29201, United States

Clarksville, Tennessee 37043, United States

Houston, Texas 77030, United States

Houston, Texas, United States

Burlington, Vermont 05401, United States

Norfolk, Virginia 23507, United States

Seattle, Washington 98105, United States

Additional Information

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Starting date: July 2006
Last updated: November 14, 2013

Page last updated: August 23, 2015

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