CompletedNot Applicable

A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A

Canada51 participantsStarted 2013-12

Plain-language summary

The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * requesting non-hormonal intrauterine contraception * able to return for ultrasound in 6-8 weeks Exclusion Criteria: * History of recent pelvic inflammatory disease * Known anemia * Dysfunctional uterine bleeding * Malignancy or suspected malignant disease of female inner or outer genitalia * Known intolerance or allergy to copper and/or copper IUDs * Any other significant disease or condition that could interfere with the subject's ability to complete the protocol * Pregnancy

What they're measuring

Expulsion Rate

Timeframe: at 6-8 weeks

Trial details

NCT IDNCT01973777

SponsorWiebe, Ellen, M.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-05

Results submitted2015-12-31

View on ClinicalTrials.gov More Contraception trials