Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
364 participants
INTERVENTIONAL
2016-12-22
2021-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Levonorgestrel IUS (Mirena, BAY86-5028)
Mirena during extended use (Years 6 to 8).
Levonorgestrel IUS (Mirena, BAY86-5028)
Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day.
Interventions
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Levonorgestrel IUS (Mirena, BAY86-5028)
Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day.
Eligibility Criteria
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Inclusion Criteria
* Women, 18 to 35 years of age at the time of screening (visit 1) who are currently using Mirena for contraception or for contraception and heavy menstrual bleeding. The duration of use of the current Mirena has to be at least 4 years 6 months at the start of screening phase but not more than 5 years at visit 2 and the woman is willing to continue with its use and has a continuing need for contraception.
* Normal or clinically insignificant cervical smear not requiring further follow up
Exclusion Criteria
* Pregnancy or suspicion of pregnancy
* Uterine bleeding of unknown etiology
* Untreated acute cervicitis or vaginitis or other lower genital tract infections
* Increased susceptibility to pelvic infection
* Acute pelvic inflammatory disease (PID) or a history of PID unless successfully treated and which, in the investigator's opinion, has not negatively affected subject's fertility
* Congenital or acquired uterine anomaly if it distorts the uterine cavity
* History of, diagnosed or suspected genital or other malignancy and untreated cervical dysplasia
* Any active acute liver disease or liver tumor (benign or malignant)
* Clinically significant endometrial polyp(s)
18 Years
35 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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Mobile, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Encinitas, California, United States
San Francisco, California, United States
Ventura, California, United States
Aurora, Colorado, United States
Atlanta, Georgia, United States
Idaho Falls, Idaho, United States
Fort Wayne, Indiana, United States
Newburgh, Indiana, United States
Frederick, Maryland, United States
Pikesville, Maryland, United States
Boston, Massachusetts, United States
Saginaw, Michigan, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Lebanon, New Hampshire, United States
Lawrenceville, New Jersey, United States
Neptune City, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Port Jefferson, New York, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Morehead City, North Carolina, United States
New Bern, North Carolina, United States
Winston-Salem, North Carolina, United States
Franklin, Ohio, United States
Mayfield Heights, Ohio, United States
Portland, Oregon, United States
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Chattanooga, Tennessee, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Draper, Utah, United States
Midlothian, Virginia, United States
North Chesterfield, Virginia, United States
Roanoke, Virginia, United States
Virginia Beach, Virginia, United States
Seattle, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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18649
Identifier Type: -
Identifier Source: org_study_id
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