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Intrauterine Device

Mona Lisa® NT Cu380 Mini for Birth Control

Phase 3
Waitlist Available
Research Sponsored by Kimberly Myer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will compare two different copper IUDs to see which is more effective.

Eligible Conditions
  • Healthy Women
  • Birth Control

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pregnancy Rate
Secondary outcome measures
Dysmenorrhea
Ease of IUD insertion as measured by asking the investigator to assess ease of insertion
Failed IUD insertion as measured by inability to place the IUD correctly
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mona Lisa® NT Cu380 MiniExperimental Treatment1 Intervention
Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity.
Group II: ParaGard® CuT380AActive Control1 Intervention
ParaGard® CuT380A containing 380mm2 of copper surface inserted into the uterine cavity.

Find a Location

Who is running the clinical trial?

Kimberly MyerLead Sponsor
FHI 360OTHER
99 Previous Clinical Trials
300,360 Total Patients Enrolled
Health DecisionsLead Sponsor
30 Previous Clinical Trials
12,897 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
California
How old are they?
18 - 65
What site did they apply to?
Essential Access Health
Columbia University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
American Journal of Obstetrics and GynecologyJournal
Comparison of Three Different Models of the Copper T Intrauterine Contraceptive Device
Roy, Subir, John Casagrande, Donna L. Cooper, and Daniel R. Mishell Jr.. 1979. “Comparison of Three Different Models of the Copper T Intrauterine Contraceptive Device”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/0002-9378(79)90843-3.
ContraceptionJournal
Prolonged Intrauterine Contraception: A Seven-year Randomized Study of the Levonorgestrel 20 Mcg/day (lng 20) and the Copper T380 Ag IUDS
Sivin, Irving, Janet Stern, Elsimar Coutinho, Carlos E.R. Mattos, Sayed El Mahgoub, Soledad Diaz, Margarita Pavez, et al.. 1991. “Prolonged Intrauterine Contraception: A Seven-year Randomized Study of the Levonorgestrel 20 Mcg/day (lng 20) and the Copper T380 Ag IUDS”. Contraception. Elsevier BV. doi:10.1016/0010-7824(91)90149-a.
ContraceptionJournal
Extended Use of the Intrauterine Device: A Literature Review and Recommendations for Clinical Practice
Wu, Justine P., and Sarah Pickle. 2014. “Extended Use of the Intrauterine Device: A Literature Review and Recommendations for Clinical Practice”. Contraception. Elsevier BV. doi:10.1016/j.contraception.2014.02.011.
The LancetJournal
Intrauterine Devices and Pelvic Inflammatory Disease: An International Perspective
Farley, T.M.M., P.J. Rowe, O. Meirik, M.J. Rosenberg, and J-H. Chen. 1992. “Intrauterine Devices and Pelvic Inflammatory Disease: An International Perspective”. The Lancet. Elsevier BV. doi:10.1016/0140-6736(92)91904-m.
~128 spots leftby Apr 2025
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