Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)
NCT ID: NCT00360490
Last Updated: 2013-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
165 participants
INTERVENTIONAL
2006-07-31
2008-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Levonorgestrel IUS (Mirena, BAY86-5028)
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA)
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Medroxyprogesterone acetate
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Interventions
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Levonorgestrel IUS (Mirena, BAY86-5028)
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Tucson, Arizona, United States
Beverly Hills, California, United States
Carmichael, California, United States
San Diego, California, United States
San Diego, California, United States
Santa Monica, California, United States
Torrance, California, United States
Littleton, Colorado, United States
Boynton Beach, Florida, United States
Jacksonville, Florida, United States
West Palm Beach, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Newburgh, Indiana, United States
South Bend, Indiana, United States
Amite, Louisiana, United States
Marrero, Louisiana, United States
Boston, Massachusetts, United States
Saginaw, Michigan, United States
Chesterfield, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
LasVegas, Nevada, United States
Moorestown, New Jersey, United States
New Brunswick, New Jersey, United States
Winston-Salem, North Carolina, United States
Medford, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Columbia, South Carolina, United States
Clarksville, Tennessee, United States
Houston, Texas, United States
Houston, Texas, United States
Burlington, Vermont, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Buenos Aires, Argentina, Argentina
Buenos Aires, Buenos Aires, Argentina
Curitiba, Paraná, Brazil
Campinas, São Paulo, Brazil
Bathurst, New Brunswick, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Mirabel, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Québec, Quebec, Canada
Shawinigan, Quebec, Canada
Regina, Saskatchewan, Canada
Mexico City, Mexico City, Mexico
Monterrey, Nuevo León, Mexico
México, State of Mexico, Mexico
Countries
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References
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Endrikat J, Vilos G, Muysers C, Fortier M, Solomayer E, Lukkari-Lax E. The levonorgestrel-releasing intrauterine system provides a reliable, long-term treatment option for women with idiopathic menorrhagia. Arch Gynecol Obstet. 2012 Jan;285(1):117-21. doi: 10.1007/s00404-011-1902-1. Epub 2011 Apr 8.
Kaunitz AM, Bissonnette F, Monteiro I, Lukkari-Lax E, DeSanctis Y, Jensen J. Levonorgestrel-releasing intrauterine system for heavy menstrual bleeding improves hemoglobin and ferritin levels. Contraception. 2012 Nov;86(5):452-7. doi: 10.1016/j.contraception.2012.07.018. Epub 2012 Sep 7.
Kaunitz AM, Bissonnette F, Monteiro I, Lukkari-Lax E, Muysers C, Jensen JT. Levonorgestrel-releasing intrauterine system or medroxyprogesterone for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):625-632. doi: 10.1097/AOG.0b013e3181ec622b.
Other Identifiers
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309849
Identifier Type: OTHER
Identifier Source: secondary_id
91518
Identifier Type: -
Identifier Source: org_study_id
NCT00360620
Identifier Type: -
Identifier Source: nct_alias