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

NCT03124160 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1105

Last updated 2024-09-25

Study results available
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Summary

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.

Conditions

  • Healthy Women
  • Female Contraception

Interventions

DRUG

Mona Lisa® NT Cu380 Mini

copper intrauterine device

DRUG

ParaGard® TCu380A

copper intrauterine device

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Premier Research

    collaborator OTHER

  • FHI 360

    lead OTHER

Principal Investigators

  • Diana Blithe · National Institute of Child Health & Human Development (NICHD)

  • David Hubacher · FHI 360

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-26
Primary Completion
2022-06-06
Completion
2022-06-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03124160 on ClinicalTrials.gov