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

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

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
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.

Study Design

• 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

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 [ 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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

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

More Information

Additional Information:

Related Info 

Publications:

Sivin I, Stern J. Long-acting, more effective copper T IUDs: a summary of U.S. experience, 1970-75. Stud Fam Plann. 1979 Oct;10(10):263-81.

Sivin I, Tatum HJ. Four years of experience with the TCu 380A intrauterine contraceptive device. Fertil Steril. 1981 Aug;36(2):159-63.

Sivin I, Stern J, Coutinho E, Mattos CE, el Mahgoub S, Diaz S, Pavez M, Alvarez F, Brache V, Thevenin F, et al. Prolonged intrauterine contraception: a seven-year randomized study of the levonorgestrel 20 mcg/day (LNg 20) and the Copper T380 Ag IUDS. Contraception. 1991 Nov;44(5):473-80.

The TCu380A, TCu220C, multiload 250 and Nova T IUDS at 3,5 and 7 years of use--results from three randomized multicentre trials. World Health Organization. Special Programme of Research, Development and Research Training in Human Reproduction: Task Force on the Safety and Efficacy of Fertility Regulating Methods. Contraception. 1990 Aug;42(2):141-58.

Hubacher D. Copper intrauterine device use by nulliparous women: review of side effects. Contraception. 2007 Jun;75(6 Suppl):S8-11. Epub 2007 Feb 20. Review.

Abraham M, Zhao Q, Peipert JF. Young Age, Nulliparity, and Continuation of Long-Acting Reversible Contraceptive Methods. Obstet Gynecol. 2015 Oct;126(4):823-9. doi: 10.1097/AOG.0000000000001036.

Benacerraf BR, Shipp TD, Lyons JG, Bromley B. Width of the normal uterine cavity in premenopausal women and effect of parity. Obstet Gynecol. 2010 Aug;116(2 Pt 1):305-10. doi: 10.1097/AOG.0b013e3181e6cc10.

Koch P, Reinhardt P, Soyka E. Intrauterine contraception using the Copper Mini-Gravigard 7 IUD: summary of 328 case histories. Contracept Deliv Syst. 1981 Apr;2(1):171-6.

Petersen KR, Brooks L, Jacobsen N, Skoby SO. Clinical performance of intrauterine devices in nulligravidae: is the length of the endometrial cavity of significance? Acta Eur Fertil. 1991 Jul-Aug;22(4):225-8.

Otero-Flores JB, Guerrero-Carreño FJ, Vázquez-Estrada LA. A comparative randomized study of three different IUDs in nulliparous Mexican women. Contraception. 2003 Apr;67(4):273-6.

Ott MA, Sucato GS; Committee on Adolescence. Contraception for adolescents. Pediatrics. 2014 Oct;134(4):e1257-81. doi: 10.1542/peds.2014-2300. Review.

Committee on Adolescent Health Care Long-Acting Reversible Contraception Working Group, The American College of Obstetricians and Gynecologists. Committee opinion no. 539: adolescents and long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol. 2012 Oct;120(4):983-8.

Curtis KM, Tepper NK, Jatlaoui TC, Berry-Bibee E, Horton LG, Zapata LB, Simmons KB, Pagano HP, Jamieson DJ, Whiteman MK. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016 Jul 29;65(3):1-103. doi: 10.15585/mmwr.rr6503a1.

Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.

Farley TM, Rosenberg MJ, Rowe PJ, Chen JH, Meirik O. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet. 1992 Mar 28;339(8796):785-8.

• Responsible Party: Health Decisions
• ClinicalTrials.gov Identifier: NCT03124160
• Other Study ID Numbers: CCN016
• First Posted: April 21, 2017
• Last Update Posted: May 15, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• 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