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

NCT01973777 | Completed Results

• 1 other identifier: 130928 IUB
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

intrauterine device, contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Complication

  12 months

• Acceptability

  12 months

Study Arms (1)

IUB

EXPERIMENTAL

There is one arm of women who will have IUBs inserted

Device: IUB

Interventions

IUB DEVICE

intrauterine contraceptive device

Also known as: SCu380A IUB™

IUB

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• requesting non-hormonal intrauterine contraception
• able to return for ultrasound in 6-8 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Wiebe, Ellen, M.D.: lead

Study Sites (1)

Willow Women's Clinic

Vancouver, British Columbia, V5Z1H9, Canada

Location

Results Point of Contact

• Title: Dr Ellen Wiebe
• Organization: University of British Columbia

ellenwiebe@gmail.com

6047095611

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: intrauterine contraceptive device IUB

Study Record Dates

• First Submitted: October 26, 2013
• First Posted: November 1, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2019
• Last Updated: September 6, 2019
• Results First Posted: February 2, 2016

Record last verified: 2019-08

Locations

CA (1)