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

Not Applicable

Completed

• Conditions: Contraception

• Registration Number: NCT01973777
• Lead Sponsor: Wiebe, Ellen, M.D.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-26
• Study First Submitted QC: 2013-10-26
• Study First Posted: 2013-11-01
• Study Start: 2013-12
• Primary Completion: 2015-05
• Results First Submitted: 2015-12-31
• Results First Submitted QC: 2015-12-31
• Results First Posted: 2016-02-02
• Status Verified: 2019-08
• Study Completion: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Expulsion Rate	at 6-8 weeks	The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus

Secondary Outcome Measures

Name	Time	Method
Acceptability	12 months	patient-reported acceptability
Complication	12 months	infection, perforation, pregnancy

Trial Locations

Locations (1)

Willow Women's Clinic; 🇨🇦 Vancouver, British Columbia, Canada