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Intrauterine Device

Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard

Phase 3
Waitlist Available
Research Sponsored by Kimberly Myer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests two types of copper IUDs in women eligible for IUD use to compare their effectiveness and safety. Copper IUDs work by releasing copper ions that prevent sperm from fertilizing an egg. The TCu 380A (Paragard) is a widely used copper IUD known for its safety and effectiveness.

Eligible Conditions
  • Healthy Women
  • Birth Control

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pregnancy Rate of Mona Lisa Copper IUD Over 3 Years
Secondary study objectives
Dysmenorrhea
Ease of IUD Insertion as Recorded by the Investigator
Failed IUD Insertion
+7 more

Side effects data

From 2022 Phase 3 trial • 1105 Patients • NCT03124160
58%
procedural pain
45%
dysmenorrhoea
36%
menorrhagia
29%
metrorrhagia
21%
pelvic pain
8%
uterine spasm
7%
abdominal pain
7%
dyspareunia
5%
bacterial vaginosis
1%
appendicitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mona Lisa® NT Cu380 Mini
ParaGard® TCu380A

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mona Lisa® NT Cu380 MiniExperimental Treatment1 Intervention
Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity.
Group II: ParaGard® TCu380AActive Control1 Intervention
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mona Lisa® NT Cu380 Mini
2017
Completed Phase 3
~1110

Find a Location

Who is running the clinical trial?

Kimberly MyerLead Sponsor
FHI 360Lead Sponsor
100 Previous Clinical Trials
300,367 Total Patients Enrolled
Health DecisionsOTHER
30 Previous Clinical Trials
12,897 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,746,602 Total Patients Enrolled
David HubacherStudy DirectorFHI 360
Diana BlitheStudy DirectorNational Institute of Child Health & Human Development (NICHD)
1 Previous Clinical Trials
136 Total Patients Enrolled
~130 spots leftby Dec 2025
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