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

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ClinicalTrials.gov Identifier: NCT03124160
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
FHI 360 - IND Holder
Information provided by (Responsible Party):
Health Decisions

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Women Female Contraception Drug: Mona Lisa® NT Cu380 Mini Drug: ParaGard® CuT380A Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Multi-center, Single-blind, Randomized Clinical Trial to Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard
Actual Study Start Date : May 26, 2017
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : November 1, 2021

Arm Intervention/treatment
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
Mona Lisa® NT Cu380 Mini

Active Comparator: ParaGard® CuT380A
ParaGard® CuT380A containing 380mm2 of copper surface inserted into the uterine cavity.
Drug: ParaGard® CuT380A
ParaGard® CuT380A




Primary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. IUD continuation at months 12, 24 and 36 as measured by confirmation of IUD placement (visible or palpable) [ Time Frame: 3 years ]
  2. Failed IUD insertion as measured by inability to place the IUD correctly [ Time Frame: 3 years ]
  3. Uterine perforation as measured by ultrasound [ Time Frame: 3 years ]
  4. IUD expulsion (complete and partial) [ Time Frame: 3 years ]
  5. Vaginal bleeding patterns [ Time Frame: 3 years ]
  6. Pelvic pain as measured in the subject diary [ Time Frame: 3 years ]
  7. Dysmenorrhea [ Time Frame: 3 years ]
  8. Other side effects as measured by adverse and/or other events [ Time Frame: 3 years ]
  9. Pain with and shortly after insertion as measured by visual analog scale completed by study subjects [ Time Frame: 3 years ]
  10. Ease of IUD insertion as measured by asking the investigator to assess ease of insertion [ Time Frame: 3 years ]
  11. Overall product satisfaction as measured by acceptability questions asked of subjects [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124160


Locations
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United States, California
Essential Access Health
Los Angeles, California, United States, 90010
University of California, Davis
Sacramento, California, United States, 95817
University of California, San Francisco
San Francisco, California, United States, 94110
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80045
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96826
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston Medical Center Corporation
Boston, Massachusetts, United States, 02118
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
United States, New York
Planned Parenthood of New York
New York, New York, United States, 10012
Columbia University
New York, New York, United States, 10032
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84106
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Health Decisions
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
FHI 360 - IND Holder
Investigators
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Study Director: Diana Blithe National Institute of Child Health & Human Development (NICHD)
Study Director: David Hubacher FHI 360

Additional Information:
Publications:

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Responsible Party: Health Decisions
ClinicalTrials.gov Identifier: NCT03124160     History of Changes
Other Study ID Numbers: CCN016
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Health Decisions:
Healthy Women
Female Contraception
IUD
Additional relevant MeSH terms:
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Copper
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs