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Completed

NCT Number: NCT01973777

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

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.

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Key information

Conditions

Contraception

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Willow Women's Clinic

Vancouver, British Columbia, V5Z1H9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IUB

Device

intrauterine contraceptive device

Other names: SCu380A IUB™

Primary outcomes

  1. Expulsion Rate

    Time frame: 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 outcomes

  1. Complication

    Time frame: 12 months

    infection, perforation, pregnancy

  2. Acceptability

    Time frame: 12 months

    patient-reported acceptability

Sponsors and collaborators

Lead sponsor

Wiebe, Ellen, M.D.

Other

Registry information

Official study title

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

Acronym: IUB

Important dates

Study start
2013
Primary completion
2015
Study completion
2019
First posted
Nov 1, 2013
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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