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

Wiebe, Ellen, M.D.

Status: Completed

Conditions: Contraception

Treatments: Device: IUB

Study type: Interventional

Funder types: Other

Identifiers

NCT01973777

130928 IUB

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

IUB

Experimental group

Description:

There is one arm of women who will have IUBs inserted

Treatment:

Device: IUB