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

N/ACompletedNCT01973777

Wiebe, Ellen, M.D.51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Contraception

Interventions

IUBDEVICE

intrauterine contraceptive device

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Willow Women's Clinic

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Expulsion Rate

The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus

Time frame: at 6-8 weeks

Secondary Outcomes

Complication

infection, perforation, pregnancy

Time frame: 12 months

Acceptability

patient-reported acceptability

Time frame: 12 months

Data from ClinicalTrials.gov

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