A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)

A Post-Marketing, Prospective, Multi-Center, Single Arm, Open Label Clinical Study to Evaluate the Safety of a New Inserter Design for Paragard® T380A Intrauterine Copper Contraceptive

The purpose of this study is to demonstrate that a new device inserter leads to successful and safe insertion of Paragard® IUS, comparable to the currently approved IUS inserter, in females of reproductive potential.

This is a post-market prospective clinical study to be conducted at multiple centers in a single arm and open-label design to evaluate the safety of a new inserter design for Paragard® (intrauterine copper contraceptive). The study will be conducted in female subjects of child bearing potential.

Inclusion Criteria:

• Subject is a postmenarcheal and premenopausal woman of child bearing potential.
• Subjects are at least 18 years of age, at the time of signing the informed consent.
• Subject is overtly healthy as determined by medical evaluation.

Exclusion Criteria:

• Pregnancy or suspicion of pregnancy or at risk for luteal phase pregnancy
• History of previous IUD complications
• Abnormalities of the uterus resulting in distortion of the uterine cavity that may complicate IUD insertion
• Known anatomical abnormalities of the cervix
• Presence of acute pelvic inflammatory disease at the time of screening.
• Postpartum endometritis.
• Known or suspected uterine or cervical malignancy.
• Uterine bleeding of unknown etiology.
• Untreated acute cervicitis or vaginitis or other lower genital tract infection.
• Conditions associated with increased susceptibility to pelvic infections.
• Subjects with Wilson's disease.