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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wiebe, Ellen, M.D.
ClinicalTrials.gov Identifier:
NCT01973777
First received: October 26, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Contraception
Device: IUB
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A Spherical Copper Intrauterine Contraceptive Device.

Resource links provided by NLM:


Further study details as provided by Wiebe, Ellen, M.D.:

Primary Outcome Measures:
  • expulsion rate [ Time Frame: at 6-8 weeks ] [ Designated as safety issue: No ]
    The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus


Secondary Outcome Measures:
  • complication [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    infection, perforation, pregnancy

  • acceptability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    patient-reported acceptability


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IUB
There is one arm of women who will have IUBs inserted
Device: IUB
intrauterine contraceptive device
Other Name: SCu380A IUB™

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973777

Locations
Canada, British Columbia
Willow Women's Clinic
Vancouver, British Columbia, Canada, V5Z1H9
Sponsors and Collaborators
Wiebe, Ellen, M.D.
  More Information

No publications provided

Responsible Party: Wiebe, Ellen, M.D.
ClinicalTrials.gov Identifier: NCT01973777     History of Changes
Other Study ID Numbers: 130928 IUB
Study First Received: October 26, 2013
Last Updated: April 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by Wiebe, Ellen, M.D.:
intrauterine device, contraception

ClinicalTrials.gov processed this record on October 23, 2014