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

Launched by COOPERSURGICAL INC. · Mar 24, 2022

Keywords

ClinConnect Summary

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.

Gender

FEMALE

Eligibility criteria

• 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.