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

A Post-Marketing, Prospective, Multi-Center, Single Arm, Open Label Clinical Study to Evaluate the Safety of a New Inserter Design for Paragard® T380A Intrauterine Copper Contraceptive

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Combination product: Paragard® T380A Intrauterine Copper Contraceptive with New Inserter

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Downtown Women's Healthcare
  • Florida
    • South Miami, Florida, United States, 33143
      • South Miami Women's Health
  • Georgia
    • Atlanta, Georgia, United States, 30363
      • GYN-CARE Women's Healthcare
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Valley Ob-Gyn Clinic, PC
  • Ohio
    • Franklin, Ohio, United States, 45005
      • HillTop Obstetrics & Gynecology
  • Texas
    • Austin, Texas, United States, 78705
      • Central Austin - Women Partners in Health
    • Austin, Texas, United States, 78758
      • Austin Area Ob-Gyn & Fertility
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Group 1; Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential

Combination product: Paragard® T380A Intrauterine Copper Contraceptive with New Inserter; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to end of treatment at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uterine Perforation and IUD Embedment	Frequency of uterine perforation and IUD embedment	From enrollment to end of treatment at 3 months
IUS Expulsions and Dislocations	Frequency of IUS expulsions (partial or total) and dislocations	From enrollment to end of treatment at 3 months
Adverse Events	Frequency of Serious Adverse Events (SAE) and Adverse Events (AE)	From enrollment to end of treatment at 3 months
Adverse Events related to Procedure	Frequency of AEs related to procedure	From enrollment to end of treatment at 3 months
Vasovagal Events	Frequency of vasovagal events at the time of insertion	From enrollment to end of treatment at 3 months
Pelvic Infections	Frequency of pelvic infections related to IUS insertion and use	From enrollment to end of treatment at 3 months

Collaborators and Investigators

• Sponsor: CooperSurgical Inc.
• Investigators: Principal Investigator: Robin Kroll, MD, Seattle Clinical Research Center; Principal Investigator: Carol Stamm, MD, Downtown Women's Healthcare; Principal Investigator: Joyce Miller, MD, South Miami Women's Health; Principal Investigator: Jacquelyn Robinson, MD, Valley Ob-Gyn Clinic, PC; Principal Investigator: Ronald Hirth, MD, HillTop Obstetrics & Gynecology; Principal Investigator: Mark Akin, MD, Austin Area Ob-Gyn & Fertility; Principal Investigator: Stephanie Reich, MD, Central Austin - Women Partners in Health; Principal Investigator: Eric L Brown, MD, GYN-CARE Women's Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2022
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): December 8, 2022

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Contraception; Intrauterine Device; Contraceptive; Birth Control; IUD; Intrauterine System; Copper Intrauterine Device; IUS
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Reproductive Control Agents; Copper; Contraceptive Agents
• Other Study ID Numbers: CSIPD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No