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

Phase 3

Active, not recruiting

• Conditions: Healthy Women; Female Contraception
• Interventions: Drug: Mona Lisa® NT Cu380 Mini; Drug: ParaGard® TCu380A

• Registration Number: NCT03124160
• Lead Sponsor: Kimberly Myer

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.

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 Timeline

• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-21
• Study Start: 2017-05-26
• Primary Completion: 2022-06-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mona Lisa® NT Cu380 Mini	Mona Lisa® NT Cu380 Mini	Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A	ParaGard® TCu380A	ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate of Mona Lisa Copper IUD Over 3 Years	3 years	Pearl Index is a measure of contraceptive efficacy used by the FDA that summarizes number of method failures per 100 person years

Secondary Outcome Measures

Name	Time	Method
IUD Continuation	3 years	IUD continuation at 36-months by product
Failed IUD Insertion	Immediate after IUD insertion attempt	Failed IUD insertion as measured by inability to place the IUD correctly
Uterine Perforation	3 years	Uterine perforation as measured by ultrasound
IUD Expulsion (Complete and Partial)	3 years	When the IUD is expelled from the uterus, either completely or partially.
Vaginal Bleeding Patterns	1 year	Proportion of cycles with heavy bleeding (more than 4 sanitary products in a day)
Pelvic Pain as Measured in the Subject Diary	1 year	Percent of cycles with any pelvic pain will be calculated using all available cycles
Dysmenorrhea	3 years	Number of participants who experienced any dysmenorrhea during the trial
Pain With and Shortly After Insertion as Recorded by Study Subjects	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
Ease of IUD Insertion as Recorded by the Investigator	Right after IUD insertion	Investigator to assess ease of IUD insertion (easy, somewhat easy, somewhat hard or hard)
Overall Product Satisfaction as Measured by Acceptability Questions Asked of Subjects	3 years	Overall product satisfaction level at exit visit (highly satisfied, satisfied, dissatisfied, highly dissatisfied)

Trial Locations

Locations (16)

Boston Medical Center Corporation; 🇺🇸 Boston, Massachusetts, United States

Columbia University; 🇺🇸 New York, New York, United States

University of Hawaii; 🇺🇸 Honolulu, Hawaii, United States

Essential Access Health; 🇺🇸 Los Angeles, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Planned Parenthood League of Massachusetts; 🇺🇸 Boston, Massachusetts, United States

Planned Parenthood of New York; 🇺🇸 New York, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States