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

September 19, 2024 updated by: FHI 360

A Multi-center, Single-blind, Randomized Clinical Trial to Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90010
        • Essential Access Health
      • Sacramento, California, United States, 95817
        • University of California, Davis
      • San Francisco, California, United States, 94110
        • University of California, San Francisco
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • University of Hawaii
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Planned Parenthood League of Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center Corporation
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10012
        • Planned Parenthood of New York
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • University of Utah
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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:

    • suspicious unexplained vaginal bleeding
    • known cervical cancer
    • known endometrial cancer
    • known Wilson's disease
    • Confirmed gestational trophoblastic disease with persistently elevated beta-hCG levels or malignant disease, with evidence or suspicion of intrauterine disease
    • anatomic abnormalities with distorted uterine cavity
    • current pelvic inflammatory disease (PID)
    • pelvic tuberculosis
    • immediately post-septic abortion or puerperal sepsis
    • current known purulent cervicitis or chlamydial infection or gonorrhea; Note: to enroll, there must be no obvious signs of infection at the time of enrollment based on pelvic exam. If lab results come back for positive infection after enrollment, treatment should be provided but the IUD can be left in place.
    • complicated solid organ transplantation
    • systemic lupus erythematosus with severe thrombocytopenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mona Lisa® NT Cu380 Mini
Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity.
Drug: Mona Lisa® NT Cu380 Mini
copper intrauterine device
Other Names:
  • NT380-Mini, NTCu380-Mini
Active Comparator: ParaGard® TCu380A
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
Drug: ParaGard® TCu380A
copper intrauterine device
Other Names:
  • T380

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pregnancy Rate of Mona Lisa Copper IUD Over 3 Years
Time Frame: 3 years
Pearl Index is a measure of contraceptive efficacy used by the FDA that summarizes number of method failures per 100 person years
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
IUD Continuation
Time Frame: 3 years
IUD continuation at 36-months by product
3 years
Failed IUD Insertion
Time Frame: Immediate after IUD insertion attempt
Failed IUD insertion as measured by inability to place the IUD correctly
Immediate after IUD insertion attempt
Uterine Perforation
Time Frame: 3 years
Uterine perforation as measured by ultrasound
3 years
IUD Expulsion (Complete and Partial)
Time Frame: 3 years
When the IUD is expelled from the uterus, either completely or partially.
3 years
Vaginal Bleeding Patterns
Time Frame: 1 year
Proportion of cycles with heavy bleeding (more than 4 sanitary products in a day)
1 year
Pelvic Pain as Measured in the Subject Diary
Time Frame: 1 year
Percent of cycles with any pelvic pain will be calculated using all available cycles
1 year
Dysmenorrhea
Time Frame: 3 years
Number of participants who experienced any dysmenorrhea during the trial
3 years
Pain With and Shortly After Insertion as Recorded by Study Subjects
Time Frame: Pain level 10 minutes after IUD insertion
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
Pain level 10 minutes after IUD insertion
Ease of IUD Insertion as Recorded by the Investigator
Time Frame: Right after IUD insertion
Investigator to assess ease of IUD insertion (easy, somewhat easy, somewhat hard or hard)
Right after IUD insertion
Overall Product Satisfaction as Measured by Acceptability Questions Asked of Subjects
Time Frame: 3 years
Overall product satisfaction level at exit visit (highly satisfied, satisfied, dissatisfied, highly dissatisfied)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FHI 360

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Health Decisions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Diana Blithe, National Institute of Child Health & Human Development (NICHD)
  • Study Director: David Hubacher, FHI 360

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCN016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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