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

Sponsored by CooperSurgical Inc.

About this trial

Last updated 3 years ago

Study ID

CSIPD-001

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18+ Years
Female

Trial Timing

Ended 3 years ago

What is this trial about?

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.

What are the participation requirements?

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.