Comparative Study of the VeraCept Low-Dose Intrauterine Copper Contraceptive vs. the TCu380 Copper IUD

Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception

The purpose of this study is to evaluate the safety and effectiveness of the VeraCept Low Dose Intrauterine Copper Contraceptive compared to the standard T shaped copper IUD, the TCu380.

This is a prospective, randomized, subject-blinded, two arm controlled study of the Safety, Feasibility and Effectiveness of the VeraCept low-dose intrauterine copper contraceptive as compared to a concurrently controlled, commercially available standard copper "T" IUD (TCu380).

Inclusion Criteria:

• Adult females ages 18 to 42 (pre-menopausal)
• Have had at least one child (parous) and currently seeking long acting reversible contraception
• Normal uterine cavity as determined by ultrasound
• Willing to sign informed consent
• Able and willing to comply with study assessment schedule

Exclusion Criteria:

• Post menopausal
• Pregnant (at time of enrollment)
• Known anatomical abnormalities of uterus, cervix and/or fallopian tubes
• Diagnosed or in treatment for cancer
• Untreated acute cervicitis
• In treatment for active Pelvic Inflammatory Disease
• Unexplained uterine bleeding or menometrorrhagia
• Known allergy to copper (Wilson's Disease) or imaging contrast media
• Unsuitable for study participation in the opinion of the Principal Investigator