N/A
Completed N=51
A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A
Source: ClinicalTrials.gov NCT01973777 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Expulsion Rate — 9 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Expulsion Rate |
9 | — |
| SECONDARY Complication |
1 | — |
| SECONDARY Acceptability |
15 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01973777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.