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

Contraception Clinical Trial

— IUB  

Official title:

A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A Spherical Copper Intrauterine Contraceptive Device.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973777
• Other study ID #: 130928 IUB
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: Wiebe, Ellen, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2019
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• IUB
intrauterine contraceptive device

Locations

Country	Name	City	State
Canada	Willow Women's Clinic	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Wiebe, Ellen, M.D.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expulsion Rate	The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus	at 6-8 weeks
Secondary	Complication	infection, perforation, pregnancy	12 months
Secondary	Acceptability	patient-reported acceptability	12 months