A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
NCT ID: NCT00995150
Last Updated: 2024-08-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1910 participants
INTERVENTIONAL
2009-11-30
2021-10-12
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
TREATMENT
NONE
Study Groups
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LNG20 (16-35 Year Olds)
LNG20 levonorgestrel-releasing intrauterine system in subjects 16-35 years of age
LNG20
levonorgestrel-releasing intrauterine system for contraception
Mirena
Levonorgestrel-releasing intrauterine system for contraception
Mirena
Mirena intrauterine system
LNG20 (36-45 Year Olds)
LNG20 levonorgestrel-releasing intrauterine system in subjects 36-45 years of age
LNG20
levonorgestrel-releasing intrauterine system for contraception
Interventions
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LNG20
levonorgestrel-releasing intrauterine system for contraception
Mirena
Mirena intrauterine system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 16-35 years old
* Cohort 36-45 years old
* Sexually active
Exclusion Criteria
* Currently breastfeeding
* Current persistent, abnormal vaginal bleeding
16 Years
45 Years
FEMALE
Yes
Sponsors
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Medicines360
OTHER
Responsible Party
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Principal Investigators
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Andrea Olariu, MD, PhD
Role: STUDY_DIRECTOR
COO
Locations
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Phoenix, Arizona, United States
Palo Alto, California, United States
San Francisco, California, United States
Vista, California, United States
Denver, Colorado, United States
Atlanta, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Des Moines, Iowa, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Magee Women's Hospital, University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Countries
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References
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Chen BA, Kimble T, Harris LH, Kerns JL, Olariu AI, Creinin MD. Levonorgestrel 52-mg Intrauterine Device Efficacy and Safety After More Than 8 Years of Use. Obstet Gynecol. 2023 May 1;141(5):1004-1006. doi: 10.1097/AOG.0000000000005147. Epub 2023 Apr 5.
Chen BA, Eisenberg DL, Schreiber CA, Turok DK, Olariu AI, Creinin MD. Bleeding changes after levonorgestrel 52-mg intrauterine system insertion for contraception in women with self-reported heavy menstrual bleeding. Am J Obstet Gynecol. 2020 Apr;222(4S):S888.e1-S888.e6. doi: 10.1016/j.ajog.2019.11.1288. Epub 2019 Dec 19.
Teal SB, Turok DK, Chen BA, Kimble T, Olariu AI, Creinin MD. Five-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52-mg Intrauterine System. Obstet Gynecol. 2019 Jan;133(1):63-70. doi: 10.1097/AOG.0000000000003034.
Schreiber CA, Teal SB, Blumenthal PD, Keder LM, Olariu AI, Creinin MD. Bleeding patterns for the Liletta(R) levonorgestrel 52 mg intrauterine system. Eur J Contracept Reprod Health Care. 2018 Apr;23(2):116-120. doi: 10.1080/13625187.2018.1449825. Epub 2018 Mar 21.
Darney PD, Stuart GS, Thomas MA, Cwiak C, Olariu A, Creinin MD. Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use. Contraception. 2018 Mar;97(3):210-214. doi: 10.1016/j.contraception.2017.10.005. Epub 2017 Oct 13.
Creinin MD, Jansen R, Starr RM, Gobburu J, Gopalakrishnan M, Olariu A. Levonorgestrel release rates over 5 years with the Liletta(R) 52-mg intrauterine system. Contraception. 2016 Oct;94(4):353-6. doi: 10.1016/j.contraception.2016.04.010. Epub 2016 Apr 25.
Eisenberg DL, Schreiber CA, Turok DK, Teal SB, Westhoff CL, Creinin MD; ACCESS IUS Investigators. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015 Jul;92(1):10-6. doi: 10.1016/j.contraception.2015.04.006. Epub 2015 Apr 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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M360-L102
Identifier Type: -
Identifier Source: org_study_id
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