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

Last updated: January 19, 2023
Sponsor: CooperSurgical Inc.
Overall Status: Completed

Phase

4

Condition

Contraception

Treatment

N/A

Clinical Study ID

NCT05309694
CSIPD-001
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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

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

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 maycomplicate 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.

Study Design

Total Participants: 119
Study Start date:
March 04, 2022
Estimated Completion Date:
December 08, 2022

Study Description

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.

Connect with a study center

  • Downtown Women's Healthcare

    Denver, Colorado 80218
    United States

    Site Not Available

  • South Miami Women's Health

    South Miami, Florida 33143
    United States

    Site Not Available

  • GYN-CARE Women's Healthcare

    Atlanta, Georgia 30363
    United States

    Site Not Available

  • Valley Ob-Gyn Clinic, PC

    Saginaw, Michigan 48602
    United States

    Site Not Available

  • Hilltop Obstetrics & Gynecology

    Franklin, Ohio 45005
    United States

    Site Not Available

  • Austin Area Ob-Gyn & Fertility

    Austin, Texas 78758
    United States

    Site Not Available

  • Central Austin - Women Partners in Health

    Austin, Texas 78705
    United States

    Site Not Available

  • Seattle Clinical Research Center

    Seattle, Washington 98105
    United States

    Site Not Available

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