Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
NCT ID: NCT00528112
Last Updated: 2017-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2885 participants
INTERVENTIONAL
2007-08-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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LCS12
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
LCS12
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h
LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
LCS16
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h
Interventions
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LCS12
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h
LCS16
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h
Eligibility Criteria
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Inclusion Criteria
* Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).
Exclusion Criteria
* History of ectopic pregnancies.
* Any genital infection (until successfully treated).
* Abnormal uterine bleeding of unknown origin.
18 Years
35 Years
FEMALE
Yes
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
Glendale, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Carmichael, California, United States
Pacific Palisades, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
Torrance, California, United States
Denver, Colorado, United States
Littleton, Colorado, United States
Boyton Beach, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
South Bend, Indiana, United States
Marrero, Louisiana, United States
Boston, Massachusetts, United States
Kalamazoo, Michigan, United States
Chaska, Minnesota, United States
Chesterfield, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Moorestown, New Jersey, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
New Bern, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Medford, Oregon, United States
Portland, Oregon, United States
Jenkintown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Columbia, South Carolina, United States
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Lanús Oeste, Buenos Aires, Argentina
San Isidro, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Calgary, Alberta, Canada
Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Waterloo, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Québec, Quebec, Canada
Shawinigan, Quebec, Canada
Sherbrooke, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Santiago, , Chile
Espoo, , Finland
Helsinki, , Finland
Helsinki, , Finland
Joensuu, , Finland
Kotka, , Finland
Kuopio, , Finland
Lahti, , Finland
Oulu, , Finland
Oulu, , Finland
Oulu, , Finland
Tampere, , Finland
Turku, , Finland
Turku, , Finland
Turku, , Finland
Compiègne, , France
Grenoble, , France
Le Chesnay, , France
Lille, , France
Nîmes, , France
Quetigny, , France
Reims, , France
Roanne, , France
Szeged, Csongrád megye, Hungary
Békéscsaba, , Hungary
Budapest, , Hungary
Eger, , Hungary
Esztergom, , Hungary
Kecskemét, , Hungary
Nyíregyháza, , Hungary
Szentes, , Hungary
Torreón, Coahuila, Mexico
México, D.F., Mexico City, Mexico
Monterrey, Nuevo León, Mexico
Hermosillo, Sonora, Mexico
México, D.F., , Mexico
México, D.F., , Mexico
Alkmaar, , Netherlands
Eindhoven, , Netherlands
Heerlen, , Netherlands
Helmond, , Netherlands
Hoofddorp, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
The Hague, , Netherlands
Utrecht, , Netherlands
Elverum, , Norway
Kolbotn, , Norway
Larvik, , Norway
Oslo, , Norway
Trondheim, , Norway
Gothenburg, , Sweden
Luleå, , Sweden
Malmo, , Sweden
Norrköping, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Countries
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References
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Nahum GG, Kaunitz AM, Rosen K, Schmelter T, Lynen R. Ovarian cysts: presence and persistence with use of a 13.5mg levonorgestrel-releasing intrauterine system. Contraception. 2015 May;91(5):412-7. doi: 10.1016/j.contraception.2015.01.021. Epub 2015 Feb 7.
Apter D, Gemzell-Danielsson K, Hauck B, Rosen K, Zurth C. Pharmacokinetics of two low-dose levonorgestrel-releasing intrauterine systems and effects on ovulation rate and cervical function: pooled analyses of phase II and III studies. Fertil Steril. 2014 Jun;101(6):1656-62.e1-4. doi: 10.1016/j.fertnstert.2014.03.004. Epub 2014 Apr 14.
Nelson A, Apter D, Hauck B, Schmelter T, Rybowski S, Rosen K, Gemzell-Danielsson K. Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial. Obstet Gynecol. 2013 Dec;122(6):1205-13. doi: 10.1097/AOG.0000000000000019.
Gemzell-Danielsson K, Apter D, Hauck B, Schmelter T, Rybowski S, Rosen K, Nelson A. The Effect of Age, Parity and Body Mass Index on the Efficacy, Safety, Placement and User Satisfaction Associated With Two Low-Dose Levonorgestrel Intrauterine Contraceptive Systems: Subgroup Analyses of Data From a Phase III Trial. PLoS One. 2015 Sep 17;10(9):e0135309. doi: 10.1371/journal.pone.0135309. eCollection 2015.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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310442
Identifier Type: OTHER
Identifier Source: secondary_id
G04209F
Identifier Type: OTHER
Identifier Source: secondary_id
G04209G
Identifier Type: OTHER
Identifier Source: secondary_id
2007-000420-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
91665
Identifier Type: -
Identifier Source: org_study_id
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