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

CooperSurgical Inc.119 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

119

Conditions

Contraception

Interventions

Paragard® T380A Intrauterine Copper Contraceptive with New InserterCOMBINATION_PRODUCT

Paragard® IUS with Investigational Inserter combines the current insertion tube and white rod to form a new pre-assembled inserter device that supports a single hand operation. The device is used to pass the IUS through the cervical canal and into the uterine cavity and facilitates insertion of the T shaped Paragard® IUS implant into the uterus.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (8)

Downtown Women's Healthcare

Denver, Colorado, United States

South Miami Women's Health

South Miami, Florida, United States

GYN-CARE Women's Healthcare

Atlanta, Georgia, United States

Valley Ob-Gyn Clinic, PC

Saginaw, Michigan, United States

Outcomes

Primary Outcomes

Successful Insertions

The percentage of successful insertions will be calculated by number of subjects with successful insertions relative to the total number of subjects with at least one successful or unsuccessful insertion attempt.