Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard
NCT ID: NCT03124160
Last Updated: 2024-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1105 participants
INTERVENTIONAL
2017-05-26
2022-06-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Mona Lisa® NT Cu380 Mini
Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity.
Mona Lisa® NT Cu380 Mini
copper intrauterine device
ParaGard® TCu380A
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A
copper intrauterine device
Interventions
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Mona Lisa® NT Cu380 Mini
copper intrauterine device
ParaGard® TCu380A
copper intrauterine device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
16 Years
40 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Premier Research
OTHER
FHI 360
OTHER
Responsible Party
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Principal Investigators
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Diana Blithe
Role: STUDY_DIRECTOR
National Institute of Child Health & Human Development (NICHD)
David Hubacher
Role: STUDY_DIRECTOR
FHI 360
Locations
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Essential Access Health
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
University of Hawaii
Honolulu, Hawaii, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Medical Center Corporation
Boston, Massachusetts, United States
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States
Planned Parenthood of New York
New York, New York, United States
Columbia University
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Countries
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References
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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.
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. doi: 10.1016/0010-7824(91)90149-a.
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. doi: 10.1016/j.contraception.2006.12.005. Epub 2007 Feb 20.
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.
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.
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-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.
Ott MA, Sucato GS; Committee on Adolescence. Contraception for adolescents. Pediatrics. 2014 Oct;134(4):e1257-81. doi: 10.1542/peds.2014-2300.
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.
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. doi: 10.1016/0140-6736(92)91904-m.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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NDA for Paragard (TCu380A)
Other Identifiers
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CCN016
Identifier Type: -
Identifier Source: org_study_id
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