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Completed NCT05309694

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

Conditions: Contraception

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 119
Sponsor: CooperSurgical Inc.

Location: Downtown Women's Healthcare Denver Colorado

Summary

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05309694). StuddyBuddy aggregates publicly available trial information.