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

Sponsor
Health Decisions (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03124160
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), FHI 360 (Other)
1,000
Enrollment
16
Locations
2
Arms
65.2
Anticipated Duration (Months)
62.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pregnancy Rate [3 years]

Secondary Outcome Measures

  1. IUD continuation at months 12, 24 and 36 as measured by confirmation of IUD placement (visible or palpable) [3 years]

  2. Failed IUD insertion as measured by inability to place the IUD correctly [3 years]

  3. Uterine perforation as measured by ultrasound [3 years]

  4. IUD expulsion (complete and partial) [3 years]

  5. Vaginal bleeding patterns [3 years]

  6. Pelvic pain as measured in the subject diary [3 years]

  7. Dysmenorrhea [3 years]

  8. Other side effects as measured by adverse and/or other events [3 years]

  9. Pain with and shortly after insertion as measured by visual analog scale completed by study subjects [3 years]

  10. Ease of IUD insertion as measured by asking the investigator to assess ease of insertion [3 years]

  11. Overall product satisfaction as measured by acceptability questions asked of subjects [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Essential Access Health Los Angeles California United States 90010
2 University of California, Davis Sacramento California United States 95817
3 University of California, San Francisco San Francisco California United States 94110
4 University of Colorado Denver Colorado United States 80045
5 University of Hawaii Honolulu Hawaii United States 96826
6 Johns Hopkins University Baltimore Maryland United States 21224
7 Boston Medical Center Corporation Boston Massachusetts United States 02118
8 Planned Parenthood League of Massachusetts Boston Massachusetts United States 02215
9 Planned Parenthood of New York New York New York United States 10012
10 Columbia University New York New York United States 10032
11 University of Cincinnati Cincinnati Ohio United States 45267
12 Oregon Health & Science University Portland Oregon United States 97239
13 University of Pennsylvania Philadelphia Pennsylvania United States 19104
14 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
15 University of Utah Salt Lake City Utah United States 84106
16 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

Investigators

  • Study Director: Diana Blithe, National Institute of Child Health & Human Development (NICHD)
  • Study Director: David Hubacher, FHI 360

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Health Decisions
ClinicalTrials.gov Identifier:
NCT03124160
Other Study ID Numbers:
  • CCN016
First Posted:
Apr 21, 2017
Last Update Posted:
Jul 9, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Jul 9, 2021