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

NCT03124160 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CCN016
• Study Type: interventional
• Target: 1,105
• Locations: 1 country
• Sites: 16

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.

Conditions

Healthy Women; Female Contraception

Keywords

Healthy Women; Female Contraception; IUD

Outcome Measures

Primary Outcomes (1)

• Pregnancy Rate of Mona Lisa Copper IUD Over 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 Outcomes (10)

• IUD Continuation

  3 years

• Failed IUD Insertion

  Immediate after IUD insertion attempt

• Uterine Perforation

  3 years

• IUD Expulsion (Complete and Partial)

  3 years

• Vaginal Bleeding Patterns

  1 year

Study Arms (2)

Mona Lisa® NT Cu380 Mini

EXPERIMENTAL

Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity.

Drug: Mona Lisa® NT Cu380 Mini

ParaGard® TCu380A

ACTIVE COMPARATOR

ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.

Drug: ParaGard® TCu380A

Interventions

Mona Lisa® NT Cu380 Mini DRUG

copper intrauterine device

Also known as: NT380-Mini, NTCu380-Mini

Mona Lisa® NT Cu380 Mini

ParaGard® TCu380A DRUG

copper intrauterine device

Also known as: T380

ParaGard® TCu380A

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• FHI 360: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Premier Research: collaborator

Study Sites (16)

Essential Access Health

Los Angeles, California, 90010, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94110, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

University of Hawaii

Honolulu, Hawaii, 96826, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Boston Medical Center Corporation

Boston, Massachusetts, 02118, United States

Location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Planned Parenthood of New York

New York, New York, 10012, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Utah

Salt Lake City, Utah, 84106, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (17)

• 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. No abstract available.

  PMID: 516121 BACKGROUND

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

  PMID: 7262334 BACKGROUND

• 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. doi: 10.1016/0010-7824(91)90149-a.

  PMID: 1797462 BACKGROUND

• 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.

  PMID: 2085966 BACKGROUND

• Hubacher D. Copper intrauterine device use by nulliparous women: review of side effects. Contraception. 2007 Jun;75(6 Suppl):S8-11. doi: 10.1016/j.contraception.2006.12.005. Epub 2007 Feb 20.

  PMID: 17531622 BACKGROUND

• Abraham M, Zhao Q, Peipert JF. Young Age, Nulliparity, and Continuation of Long-Acting Reversible Contraceptive Methods. Obstet Gynecol. 2015 Oct;126(4):823-829. doi: 10.1097/AOG.0000000000001036.

  PMID: 26348177 BACKGROUND

• 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):305-310. doi: 10.1097/AOG.0b013e3181e6cc10.

  PMID: 20664389 BACKGROUND

• 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.

  PMID: 12336868 BACKGROUND

• 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.

  PMID: 1844327 BACKGROUND

• Otero-Flores JB, Guerrero-Carreno FJ, Vazquez-Estrada LA. A comparative randomized study of three different IUDs in nulliparous Mexican women. Contraception. 2003 Apr;67(4):273-6. doi: 10.1016/s0010-7824(02)00519-x.

  PMID: 12684147 BACKGROUND

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

  PMID: 25266435 BACKGROUND

• 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. doi: 10.1097/AOG.0b013e3182723b7d.

  PMID: 22996129 BACKGROUND

• 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.

  PMID: 27467196 BACKGROUND

• 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.

  PMID: 25601352 BACKGROUND

• 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. doi: 10.1016/0140-6736(92)91904-m.

  PMID: 1347812 BACKGROUND

• Schreiber CA, Nanda K, Hubacher D, Turok DK, Jensen JT, Creinin MD, White KO, Dayananda I, Teal SB, Chen PL, Chen BA, Goldberg AB, Kerns JL, Dart C, Nelson AL, Thomas MA, Archer DF, Brown JE, Castano PM, Burke AE, Kaneshiro B, Blithe DL. Contraceptive Efficacy and Comparative Side Effects of a Mini Copper Intrauterine Device. NEJM Evid. 2025 Aug;4(8):EVIDoa2400480. doi: 10.1056/EVIDoa2400480. Epub 2025 Jul 22.

  PMID: 40693846 DERIVED

• Hubacher D, Schreiber CA, Turok DK, Jensen JT, Creinin MD, Nanda K, White KO, Dayananda I, Teal SB, Chen PL, Chen BA, Goldberg AB, Kerns JL, Dart C, Nelson AL, Thomas MA, Archer DF, Brown JE, Castano PM, Burke AE, Kaneshiro B, Blithe DL. Continuation rates of two different-sized copper intrauterine devices among nulliparous women: Interim 12-month results of a single-blind, randomised, multicentre trial. EClinicalMedicine. 2022 Jul 16;51:101554. doi: 10.1016/j.eclinm.2022.101554. eCollection 2022 Sep.

  PMID: 35865736 DERIVED

Related Links

• NDA for Paragard (TCu380A)

Results Point of Contact

• Title: David Hubacher
• Organization: FHI 360

dhubacher@fhi360.org

+1-919-321-3459

Study Officials

• Diana Blithe

  National Institute of Child Health & Human Development (NICHD)

  STUDY DIRECTOR

• David Hubacher

  FHI 360

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: April 21, 2017
• Study Start: May 26, 2017
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)