Study Stopped
The data cutoff date of 05 April 2021 was chosen as it coincides with all subjects completing through Year 8 of use (intended duration of use for the product).
A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
1 other identifier
interventional
1,910
1 country
25
Brief Summary
The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who request long-term, reversible contraception for up to 10 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2009
Longer than P75 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2021
CompletedResults Posted
Study results publicly available
August 14, 2024
CompletedAugust 14, 2024
July 1, 2024
12 years
October 13, 2009
October 31, 2023
July 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Pregnancies Per Year
Number of pregnancies per year in each treatment arm.
10 years
Cumulative Pearl Index
The Pearl Index (PI) is an estimate of the number of pregnancies per 100 women-years of contraceptive exposure. The Pearl Index is calculated as the number of "on treatment" pregnancies in the study divided by the total number of complete 28-day cycles of use in the study multiplied by 1,300 (13 cycles/yr x 100 years). Cycles where other birth control methods were used were excluded from this measure. The Pearl Index for MIRENA was not a pre-specified primary outcome measure and is therefore not included. There is only 8 years of data due to the early termination of the study.
8 years
Secondary Outcomes (14)
Safety and Tolerability
10 Years
Distribution of Bleeding Amenorrhea by 90 Day Interval
8 Years
Continuation Rates
10 Years
Return of Menses After Discontinuation
5 months
Return to Fertility After Discontinuation
12 months
- +9 more secondary outcomes
Study Arms (3)
LNG20 (16-35 Year Olds)
EXPERIMENTALLNG20 levonorgestrel-releasing intrauterine system in subjects 16-35 years of age
Mirena
ACTIVE COMPARATORLevonorgestrel-releasing intrauterine system for contraception
LNG20 (36-45 Year Olds)
EXPERIMENTALLNG20 levonorgestrel-releasing intrauterine system in subjects 36-45 years of age
Interventions
Eligibility Criteria
You may qualify if:
- Healthy women requesting contraception
- years old
- Cohort 36-45 years old
- Sexually active
You may not qualify if:
- Currently pregnant, pregnant within 4 weeks prior to study entry or planning pregnancy within 24 months of study entry
- Currently breastfeeding
- Current persistent, abnormal vaginal bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medicines360lead
Study Sites (25)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Palo Alto, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Vista, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Idaho Falls, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Chapel Hill, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Magee Women's Hospital, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Related Publications (7)
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.
PMID: 37023451DERIVEDChen 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.
PMID: 31866516DERIVEDTeal 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.
PMID: 30531565DERIVEDSchreiber 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.
PMID: 29560743DERIVEDDarney 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.
PMID: 29038072DERIVEDCreinin 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.
PMID: 27125892DERIVEDEisenberg 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.
PMID: 25934164DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Emily Morris
- Organization
- Medicines360
Study Officials
- STUDY DIRECTOR
Andrea Olariu, MD, PhD
COO
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2009
First Posted
October 15, 2009
Study Start
November 1, 2009
Primary Completion
October 12, 2021
Study Completion
October 12, 2021
Last Updated
August 14, 2024
Results First Posted
August 14, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share