This trial is active, not recruiting.

Condition contraception
Treatment iub
Phase phase 2/phase 3
Sponsor Wiebe, Ellen, M.D.
Start date December 2013
End date January 2015
Trial size 50 participants
Trial identifier NCT01973777, 130928 IUB


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
There is one arm of women who will have IUBs inserted
iub SCu380A IUB™
intrauterine contraceptive device

Primary Outcomes

expulsion rate
time frame: at 6-8 weeks

Secondary Outcomes

time frame: 12 months
time frame: 12 months

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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

Additional Information

Official title A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A Spherical Copper Intrauterine Contraceptive Device.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Wiebe, Ellen, M.D..