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