Status and phase
Conditions
Treatments
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
16-40 years
o 16 and 17 year olds, where permissible by state regulations and local Institutional Review Board (IRB) approval
Sexually active, anticipating at least one act of vaginal intercourse per menstrual cycle with a male partner and at risk for pregnancy
seeking contraception, and willing to use the study IUD as the only contraception method
willing to be randomized to one of the two copper IUDs
has an intact uterus and at least one ovary
has a history of regular menstrual cycles; defined as occurring every 21-35 days when not using hormones, and with a variation of typical cycle length of no more than 5 days
able and willing to provide written informed consent
agrees to follow all study requirements
not currently pregnant or at risk for luteal phase pregnancy based on history of unprotected intercourse
Exclusion criteria
abnormal Pap requiring treatment after enrollment
known human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS) infection
intending to become pregnant in the 37 months after enrollment
known infertility
history of allergy or sensitivity to copper
previous tubal sterilization
has received an injectable contraceptive in the last 9 months and has not resumed regular menstrual cycles (as evidenced by 2 spontaneous menses)
within 30 days of administration of mifepristone and/or misoprostol for medical abortion or for miscarriage management
within 30 days of first, second, or third trimester abortion or miscarriage (note: potential abortion/miscarriage participants can be screened and return after 30 days for randomization and IUD insertion)
within 30 days of delivery (for parous population)
breastfeeding or recently breastfeeding women unless two consecutive normal menstrual periods have occurred after delivery and prior to enrollment.
wants to use a copper IUD for emergency contraception
has previously participated in the study
participated in another clinical trial involving an investigational product within the last 30 days (before screening) or planning to participate in another clinical trial involving an intervention or treatment during this study
not living in the catchment area of the study site or planning to move from the area within the year (unless known to be moving to the catchment area of another study site)
known or suspected current alcohol or drug abuse
planning to undergo major surgery during study participation
current need for use of exogenous hormones or therapeutic anticoagulants (Note: subjects who start a therapeutic anticoagulant after enrolment will be allowed to continue in the study.)
at high risk for sexually-transmitted infections or pelvic infection
anticipated need for regular condom use (refer to Section 8.1).
has any condition (social or medical) which in the opinion of the Investigator would make study participation unsafe or complicate data interpretation
Reported medical contraindications (Medical Eligibility Criteria category 3 or 4)14 to copper IUDs, including:
Primary purpose
Allocation
Interventional model
Masking
1,105 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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