This will be a multi-site, participant-blinded, randomized clinical trial. The investigators will randomize 1000 eligible participants in a 4:1 ratio to two different copper IUDs: 800 to Mona Lisa NT Cu380 Mini and 200 to ParaGard.
The total duration of the study for each participant is expected to be approximately 39 months: including screening and enrollment (up to 30 days to meet enrollment criteria), 37 months of participation, and a post-removal follow up telephone call 17 days post-removal. After enrollment, subject visits occur at 6 weeks, 3 months, 6 months, 12 months, 24 months, with telephone calls at 9, 18, and 30 months and seen again at 37 months for their final visit. Subjects will use a home pregnancy test 17 days post-removal of the IUD or Exit Visit procedures, whichever occurs first, and called by the site for the result and for safety follow-up. Subject recruitment is expected to begin Q2 (in the second quarter of) 2017 and is planned to continue through Q2 2018. However, if the enrollment rate declines, the enrollment period may be extended beyond this date. If this enrollment timeline is met, all subjects should finish active treatment by approximately the end of Q2 2021. The total duration of the study will be approximately 48 months for each study site including pre- and post- trial activities. The end of the study will occur when the last subject to be enrolled has completed her post-removal pregnancy test telephone call. Total duration of the project is expected to be five years. Preliminary results of the study are expected to be available Q4 of 2019 based on the current study plan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
1,105
copper intrauterine device
copper intrauterine device
Essential Access Health
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
Pregnancy Rate of Mona Lisa Copper IUD Over 3 Years
Pearl Index is a measure of contraceptive efficacy used by the FDA that summarizes number of method failures per 100 person years
Time frame: 3 years
IUD Continuation
IUD continuation at 36-months by product
Time frame: 3 years
Failed IUD Insertion
Failed IUD insertion as measured by inability to place the IUD correctly
Time frame: Immediate after IUD insertion attempt
Uterine Perforation
Uterine perforation as measured by ultrasound
Time frame: 3 years
IUD Expulsion (Complete and Partial)
When the IUD is expelled from the uterus, either completely or partially.
Time frame: 3 years
Vaginal Bleeding Patterns
Proportion of cycles with heavy bleeding (more than 4 sanitary products in a day)
Time frame: 1 year
Pelvic Pain as Measured in the Subject Diary
Percent of cycles with any pelvic pain will be calculated using all available cycles
Time frame: 1 year
Dysmenorrhea
Number of participants who experienced any dysmenorrhea during the trial
Time frame: 3 years
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University of California, San Francisco
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
University of Hawaii
Honolulu, Hawaii, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Medical Center Corporation
Boston, Massachusetts, United States
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States
Planned Parenthood of New York
New York, New York, United States
Columbia University
New York, New York, United States
...and 6 more locations
Pain With and Shortly After Insertion as Recorded by Study Subjects
Pain level on scale of 0=no pain to 10=worst imaginable pain as displayed on a paper form for study subject to indicate their level of pain
Time frame: Pain level 10 minutes after IUD insertion
Ease of IUD Insertion as Recorded by the Investigator
Investigator to assess ease of IUD insertion (easy, somewhat easy, somewhat hard or hard)
Time frame: Right after IUD insertion
Overall Product Satisfaction as Measured by Acceptability Questions Asked of Subjects
Overall product satisfaction level at exit visit (highly satisfied, satisfied, dissatisfied, highly dissatisfied)
Time frame: 3 years