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

Female Contraception Clinical Trial

Official title:

A Multi-center, Single-blind, Randomized Clinical Trial to Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03124160
• Other study ID #: CCN016
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 26, 2017
• Est. completion date: September 30, 2023

Study information

• Verified date: September 2023
• Source: Health Decisions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2023
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Female Contraception
• Healthy Women

Intervention

Drug:
• Mona Lisa® NT Cu380 Mini
Mona Lisa® NT Cu380 Mini
• ParaGard® CuT380A
ParaGard® CuT380A

Locations

Country	Name	City	State
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	University of Cincinnati	Cincinnati	Ohio
United States	University of Colorado	Denver	Colorado
United States	University of Hawaii	Honolulu	Hawaii
United States	Essential Access Health	Los Angeles	California
United States	Columbia University	New York	New York
United States	Planned Parenthood of New York	New York	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	University of California, Davis	Sacramento	California
United States	University of Utah	Salt Lake City	Utah
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Kimberly Myer	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), FHI 360

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate		3 years
Secondary	IUD continuation at months 12, 24 and 36 as measured by confirmation of IUD placement (visible or palpable)		3 years
Secondary	Failed IUD insertion as measured by inability to place the IUD correctly		3 years
Secondary	Uterine perforation as measured by ultrasound		3 years
Secondary	IUD expulsion (complete and partial)		3 years
Secondary	Vaginal bleeding patterns		3 years
Secondary	Pelvic pain as measured in the subject diary		3 years
Secondary	Dysmenorrhea		3 years
Secondary	Other side effects as measured by adverse and/or other events		3 years
Secondary	Pain with and shortly after insertion as measured by visual analog scale completed by study subjects		3 years
Secondary	Ease of IUD insertion as measured by asking the investigator to assess ease of insertion		3 years
Secondary	Overall product satisfaction as measured by acceptability questions asked of subjects		3 years

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